|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Extent of Recognition
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Standard Title (click for recognition information)
|
07/06/2020 |
Tissue Engineering |
15-59 |
Complete |
ASTM |
F2450-18 |
Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products |
07/06/2020 |
Tissue Engineering |
15-61 |
Complete |
ASTM |
F2150-19 |
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products |
04/04/2016 |
Tissue Engineering |
15-24 |
Complete |
ASTM |
F2721-09 (Reapproved 2014) |
Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects |
07/06/2020 |
Tissue Engineering |
15-62 |
Complete |
ASTM |
F2602-18 |
Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
07/06/2020 |
Tissue Engineering |
15-63 |
Complete |
ASTM |
F2739-19 |
Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds |
01/14/2019 |
Tissue Engineering |
15-56 |
Complete |
ASTM |
F3224-17 |
Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging |
07/15/2019 |
Tissue Engineering |
15-57 |
Complete |
ASTM |
F2315-18 |
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
07/15/2019 |
Tissue Engineering |
15-58 |
Complete |
ASTM |
F2103-18 |
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
01/14/2019 |
Tissue Engineering |
15-47 |
Complete |
ISO |
22442-3 First edition 2007-12-15 |
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents. |
06/07/2018 |
Tissue Engineering |
15-54 |
Complete |
ASTM |
F3207-17 |
Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model |
09/17/2018 |
Tissue Engineering |
15-55 |
Complete |
ASTM |
F3259-17 |
Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds |
06/07/2018 |
Tissue Engineering |
15-51 |
Complete |
ASTM |
F2347-15 |
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
06/07/2018 |
Tissue Engineering |
15-52 |
Complete |
ASTM |
F2064-17 |
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
06/07/2018 |
Tissue Engineering |
15-53 |
Complete |
ASTM |
F3206-17 |
Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies |
08/21/2017 |
Tissue Engineering |
15-49 |
Complete |
ASTM |
F2027-16 |
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
07/09/2014 |
Tissue Engineering |
15-40 |
Complete |
ASTM |
F2211-13 |
Standard Classification for Tissue Engineered Medical Products (TEMPs) |
03/16/2012 |
Tissue Engineering |
15-31 |
Complete |
ASTM |
F2312-11 (Reapproved 2020) |
Standard Terminology Relating to Tissue Engineered Medical Products |
08/06/2013 |
Tissue Engineering |
15-14 |
Complete |
ASTM |
F2603-06 (Reapproved 2020) |
Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds |
04/04/2016 |
Tissue Engineering |
15-43 |
Complete |
ASTM |
F2791-15 |
Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
12/23/2016 |
Tissue Engineering |
15-48 |
Complete |
ASTM |
F2605-16 |
Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
06/07/2021 |
Tissue Engineering |
15-67 |
Complete |
ASTM |
F2212-20 |
Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
12/21/2020 |
Tissue Engineering |
15-65 |
Complete |
ISO |
22442-2 Third edition 2020-09 |
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling |
06/07/2021 |
Tissue Engineering |
15-66 |
Complete |
ASTM |
F2260-18 |
Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy |
04/04/2016 |
Tissue Engineering |
15-44 |
Partial |
ASTM |
F2529-13 |
Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) |
12/21/2020 |
Tissue Engineering |
15-64 |
Partial |
ISO |
22442-1 Third edition 2020-09 |
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
01/30/2014 |
Sterility |
14-401 |
Complete |
ASTM |
F2217/F2217M-13 (Reapproved 2018) |
Standard Practice for Coating/Adhesive Weight Determination |
05/30/2022 |
Sterility |
14-574 |
Complete |
ASTM |
F1608-21 |
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
05/30/2022 |
Sterility |
14-576 |
Complete |
ASTM |
D4169-22 |
Standard Practice for Performance Testing of Shipping Containers and Systems |
12/23/2016 |
Sterility |
14-497 |
Complete |
ASTM |
F1980-16 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
12/18/2023 |
Sterility |
14-589 |
Complete |
ISO |
14644-4 Second edition 2022-11 |
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
06/07/2021 |
Sterility |
14-562 |
Complete |
ANSI AAMI |
ST79:2017 & 2020 Amendments A1, A2, A3, A4 |
(Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
01/30/2014 |
Sterility |
14-429 |
Complete |
ISO ASTM |
51275 Third edition 2013-06-01 |
Practice for use of a radiochromic film dosimetry system |
01/30/2014 |
Sterility |
14-427 |
Complete |
ISO |
13408-1 Second edition 2008-06-15 |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
12/18/2023 |
Sterility |
14-593 |
Complete |
ASTM |
F3039-23 |
Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
12/20/2021 |
Sterility |
14-564 |
Complete |
USP-NF |
M98910_01_01 |
<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests |
02/20/2023 |
Sterility |
14-575 |
Complete |
ASTM |
F1980-21 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
12/19/2022 |
Sterility |
14-581 |
Complete |
ASTM |
F2638-22 |
Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier |
12/19/2022 |
Sterility |
14-582 |
Complete |
AAMI ISO |
TIR11137-4:2022 |
Sterilization of health care products - Radiation - Part 4: Guidance on process control |
ISO |
TS 11137-4 First edition 2020-06 |
Sterilization of health care products - Radiation - Part 4: Guidance on process control |
12/19/2022 |
Sterility |
14-583 |
Complete |
ANSI AAMI |
ST98:2022 |
Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices |
01/27/2015 |
Sterility |
14-389 |
Complete |
ISO |
14644-9 First edition 2012-08-15 |
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration |
12/18/2023 |
Sterility |
14-591 |
Complete |
ISO |
14644-10 Second edition 2022-05 |
Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination |
07/09/2014 |
Sterility |
14-282 |
Complete |
ASTM |
F2338-09 (Reapproved 2020) |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method |
07/09/2014 |
Sterility |
14-437 |
Complete |
ISO ASTM |
52701 First edition 2013-11-15 (R2020) |
Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing |
05/29/2023 |
Sterility |
14-587 |
Complete |
AAMI |
TIR104:2022 |
Guidance on transferring health care products between radiation sterilization sources |
01/14/2019 |
Sterility |
14-518 |
Complete |
AAMI ANSI |
ST55:2016/(R)2023 |
Table-top steam sterilizers |
07/15/2019 |
Sterility |
14-529 |
Complete |
ISO |
11135 Second edition 2014-07-15 |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] |
ANSI AAMI ISO |
11135:2014/A1:2018 |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release |
12/20/2021 |
Sterility |
14-571 |
Complete |
ISO |
11138-8 First edition 2021-07 |
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator |
01/30/2014 |
Sterility |
14-412 |
Complete |
AOAC |
6.2.01:2013 |
Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method |
05/29/2023 |
Sterility |
14-585 |
Complete |
AAMI ISO |
TIR16775:2023 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
ISO |
TS 16775 Second edition 2021-11 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
06/27/2016 |
Sterility |
14-483 |
Complete |
ISO ASTM |
52303 First edition 2015-07-15 |
Guide for absorbed-dose mapping in radiation processing facilities |
01/15/2013 |
Sterility |
14-213 |
Complete |
AOAC |
6.2.03:2006 |
Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method |
01/15/2013 |
Sterility |
14-215 |
Complete |
AOAC |
6.2.05:2006 |
Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method |
01/15/2013 |
Sterility |
14-217 |
Complete |
AOAC |
6.3.02:2006 |
Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes |
09/09/2008 |
Sterility |
14-191 |
Complete |
ISO |
13408-4 First edition 2005-11-01 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
ANSI AAMI ISO |
13408-4:2005/(R)2014 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
09/09/2008 |
Sterility |
14-240 |
Complete |
ISO |
13408-5 First edition 2006-11-15 |
Aseptic processing of health care products - Part 5: Sterilization-in-place |
ANSI AAMI ISO |
13408-5:2006/(R)2015 |
Aseptic processing of health care products - Part 5: Sterilization in place |
04/04/2016 |
Sterility |
14-277 |
Complete |
ANSI AAMI ISO |
TIR 17665-2:2009 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1 |
ISO |
TS 17665-2 First edition 2009-01-15 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 |
08/06/2013 |
Sterility |
14-388 |
Complete |
ISO |
13408-7 First edition 2012-08-01 |
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products |
ANSI AAMI ISO |
13408-7:2012 (R2018) |
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products |
01/27/2015 |
Sterility |
14-456 |
Complete |
ANSI AAMI ISO |
TIR16775:2014 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
ISO |
TS 16775 First edition 2014-05-15 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
01/15/2013 |
Sterility |
14-212 |
Complete |
AOAC |
6.2.02:2006 |
Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method |
05/29/2023 |
Sterility |
14-586 |
Complete |
ISO |
22441 First edition 2022-08 |
Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
07/09/2014 |
Sterility |
14-286 |
Complete |
ANSI AAMI |
ST65:2008/(R)2018 |
Processing of reusable surgical textiles for use in health care facilities |
07/09/2014 |
Sterility |
14-433 |
Complete |
ASTM |
F2227-13 (Reapproved 2021) |
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method |
01/27/2015 |
Sterility |
14-243 |
Complete |
ISO |
14644-6 First edition 2007-07-15 |
Cleanrooms and associated controlled environments - Part 6: Vocabulary |
05/30/2022 |
Sterility |
14-573 |
Complete |
ASTM |
F88/F88M-21 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
12/18/2023 |
Sterility |
14-597 |
Complete |
AAMI ANSI |
ST108:2023 |
Water for the processing of medical devices |
01/27/2015 |
Sterility |
14-165 |
Complete |
ISO |
14644-5 First edition 2004-08-15 |
Cleanrooms and associated controlled environments - Part 5: Operations |
07/09/2014 |
Sterility |
14-257 |
Complete |
ASTM |
D3078-02 (Reapproved 2021)e1 |
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission |
08/06/2013 |
Sterility |
14-383 |
Complete |
ISO ASTM |
51702 Third edition 2013-04-15 |
Practice for dosimetry in a gamma facility for radiation processing |
08/06/2013 |
Sterility |
14-381 |
Complete |
ISO ASTM |
51261 Second edition 2013-04-15 |
Practice for calibration of routine dosimetry systems for radiation processing |
08/21/2017 |
Sterility |
14-501 |
Complete |
ASTM |
F1886/F1886M-16 |
Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection |
07/09/2014 |
Sterility |
14-432 |
Complete |
ANSI AAMI |
ST58:2013/(R)2018 |
Chemical sterilization and high-level disinfection in health care facilities |
12/20/2021 |
Sterility |
14-563 |
Complete |
ISO |
13408-6 Second edition 2021-04 |
Aseptic processing of health care products - Part 6: Isolator systems |
12/21/2020 |
Sterility |
14-553 |
Complete |
ASTM |
F2097-20 |
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
09/09/2008 |
Sterility |
14-142 |
Complete |
ISO |
14698-1:2003 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods |
01/27/2015 |
Sterility |
14-141 |
Complete |
ISO |
14644-4 First edition 2001-04-01 |
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
12/18/2023 |
Sterility |
14-590 |
Complete |
ISO |
14644-8 Third edition 2022-06 |
Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) |
09/17/2018 |
Sterility |
14-294 |
Complete |
ANSI AAMI |
ST40:2004/(R)2018 |
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities |
03/16/2012 |
Sterility |
14-332 |
Complete |
ISO |
11140-5 Second edition 2007-03-15 |
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
ANSI AAMI ISO |
11140-5:2007/(R)2012 |
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs |
01/27/2015 |
Sterility |
14-242 |
Complete |
ISO |
14644-3 First edition 2005-12-15 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
01/15/2013 |
Sterility |
14-359 |
Complete |
ASTM |
F2096-11 (Reapproved 2019) |
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) |
06/27/2016 |
Sterility |
14-481 |
Complete |
ISO |
14644-2 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
07/15/2019 |
Sterility |
14-531 |
Complete |
ISO |
11607-2 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
ANSI AAMI ISO |
11607-2:2019 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
12/18/2023 |
Sterility |
14-596 |
Complete |
ASTM |
F88/F88M-23 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
01/30/2014 |
Sterility |
14-406 |
Complete |
ANSI AAMI |
ST8:2013/(R)2018 |
Hospital steam sterilizers |
01/30/2014 |
Sterility |
14-405 |
Complete |
ASTM |
F2252/F2252M-13 (Reapproved 2018) |
Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape |
06/27/2015 |
Sterility |
14-484 |
Complete |
ASTM |
F1929-15 |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
05/29/2023 |
Sterility |
14-588 |
Complete |
AAMI |
TIR17:2017/(R)2020 |
Compatibility of materials subjected to sterilization |
09/17/2018 |
Sterility |
14-517 |
Complete |
ASTM |
F3293-18 |
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
07/15/2019 |
Sterility |
14-530 |
Complete |
ISO |
11607-1 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
ANSI AAMI ISO |
11607-1:2019 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
12/18/2023 |
Sterility |
14-595 |
Complete |
ISO |
11607-2 Second edition 2019-02 [Including AMD1:2023] |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)]. |
12/23/2016 |
Sterility |
14-169 |
Complete |
ASTM |
F2391-05 (Reapproved 2016) |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
06/07/2018 |
Sterility |
14-510 |
Complete |
ISO |
11137-3 Second edition 2017-06 |
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
ANSI AAMI ISO |
11137-3:2017/(R)2023 |
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
09/09/2008 |
Sterility |
14-239 |
Complete |
ISO |
13408-3 First edition 2006-09-15 |
Aseptic processing of health care products - Part 3: Lyophilization |
ANSI AAMI ISO |
13408-3:2006/(R)2015 |
Aseptic processing of health care products - Part 3: Lyophilization |
09/17/2018 |
Sterility |
14-513 |
Complete |
ASTM |
F2825-18 |
Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery |
07/09/2014 |
Sterility |
14-434 |
Complete |
ASTM |
F2228-13 (Reapproved 2021) |
Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method |
07/09/2014 |
Sterility |
14-256 |
Complete |
ASTM |
F2095-07 (Reapproved 2021) |
Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates |
07/09/2014 |
Sterility |
14-435 |
Complete |
ASTM |
F2251-13 (Reapproved 2023) |
Standard Test Method for Thickness Measurement of Flexible Packaging Material |
07/09/2014 |
Sterility |
14-290 |
Complete |
ANSI AAMI |
ST24:1999/(R)2018 |
Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed. |
08/21/2017 |
Sterility |
14-502 |
Complete |
ISO |
11138-1 Third edition 2017-03 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
ANSI AAMI ISO |
11138-1:2017 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
01/30/2014 |
Sterility |
14-397 |
Complete |
AOAC |
6.2.04:2013 |
Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method |
01/30/2014 |
Sterility |
14-398 |
Complete |
AOAC |
6.3.05:2013 |
Official Method 966.04, Sporicidal Activity of Disinfectants Method I |
01/30/2014 |
Sterility |
14-399 |
Complete |
AOAC |
6.3.06:2012 |
Official Method 965.12 Tuberculocidal Activity of Disinfectants |
01/30/2014 |
Sterility |
14-400 |
Complete |
ASTM |
F2203-13 (Reapproved 2022) |
Standard Test Method for Linear Measurement Using Precision Steel Rule |
01/30/2014 |
Sterility |
14-402 |
Complete |
ASTM |
F1140/F1140M-13 (Reapproved 2020)e1 |
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages |
01/30/2014 |
Sterility |
14-404 |
Complete |
ASTM |
F2250-13 (Reapproved 2018) |
Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials |
01/27/2015 |
Sterility |
14-166 |
Complete |
ISO |
14644-7 First edition 2004-10-01 |
Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
09/17/2018 |
Sterility |
14-512 |
Complete |
ISO |
13408-2 Second edition 2018-01 |
Aseptic processing of health care products - Part 2: Sterilizing filtration. |
ANSI AAMI ISO |
13408-2:2018 |
Aseptic processing of health care products - Part 2:Sterilizing filtration |
09/17/2018 |
Sterility |
14-275 |
Complete |
ANSI AAMI |
ST41:2008/(R)2018 |
Ethylene oxide sterilization in health care facilities: Safety and effectiveness |
04/04/2016 |
Sterility |
14-337 |
Complete |
ISO |
14937 Second edition 2009-10-15 |
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
ANSI AAMI ISO |
14937:2009/(R)2013 |
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices |
07/06/2020 |
Sterility |
14-539 |
Complete |
ASTM |
F2475-20 |
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
12/18/2023 |
Sterility |
14-592 |
Complete |
ISO |
13408-1 Third edition 2023-08 |
Aseptic processing of health care products - Part 1: General requirements |
09/17/2018 |
Sterility |
14-293 |
Complete |
ANSI AAMI |
ST50:2004/(R)2018 |
Dry heat (heated air) sterilizers |
08/14/2015 |
Sterility |
14-464 |
Complete |
ISO ASTM |
51649 Third edition 2015-03-15 |
Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV |
08/14/2015 |
Sterility |
14-465 |
Complete |
ISO ASTM |
51707 Third edition 2015-03-15 |
Guide for estimating uncertainties in dosimetry for radiation processing |
08/14/2015 |
Sterility |
14-463 |
Complete |
ISO ASTM |
51608 Second edition 2015-03-15 |
Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV |
01/30/2014 |
Sterility |
14-403 |
Complete |
ASTM |
F2054/F2054M-13 (Reapproved 2020) |
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates |
01/30/2014 |
Sterility |
14-430 |
Complete |
ISO ASTM |
51607 Third edition 2013-06-01 |
Practice for use of an alanine-EPR dosimery system |
09/17/2018 |
Sterility |
14-516 |
Complete |
ASTM |
F3039-15 |
Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
12/18/2023 |
Sterility |
14-594 |
Complete |
ISO |
11607-1 Second edition 2019-02 [Including AMD1:2023] |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)] |
01/27/2015 |
Sterility |
14-379 |
Complete |
ISO |
14644-8 Second edition 2013-02-15 |
Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) |
05/29/2023 |
Sterility |
14-584 |
Complete |
ASTM |
F2391-22 |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
07/06/2020 |
Sterility |
14-541 |
Complete |
ANSI AAMI |
ST72:2019 |
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing |
12/21/2020 |
Sterility |
14-550 |
Complete |
ANSI AAMI |
ST67:2019 |
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile" |
12/21/2020 |
Sterility |
14-552 |
Complete |
ISO ASTM |
51818 Fourth edition 2020-06 |
Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV |
07/06/2020 |
Sterility |
14-543 |
Complete |
ISO |
11139 First edition 2018-08 |
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards |
07/06/2020 |
Sterility |
14-544 |
Complete |
ISO |
18472 Second edition 2018-08 |
Sterilization of health care products - Biological and chemical indicators - Test equipment |
12/23/2019 |
Sterility |
14-538 |
Complete |
ASTM |
F3357-19 |
Standard Guide for Designing Reusable Medical Devices for Cleanability |
05/30/2022 |
Sterility |
14-579 |
Complete |
ISO |
17664-2 First edition 2021-02 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. |
12/20/2021 |
Sterility |
14-566 |
Complete |
USP-NF |
M98795_02_01 |
<55> Biological Indicators -- Resistance Performance Tests |
12/20/2021 |
Sterility |
14-567 |
Complete |
USP-NF |
M7414_01_01 |
<1229.5> Biological Indicators for Sterilization |
12/20/2021 |
Sterility |
14-568 |
Complete |
USP-NF |
M98800_01_01 |
<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests |
12/20/2021 |
Sterility |
14-569 |
Complete |
USP-NF |
M98810_01_01 |
<71> Sterility Tests |
12/20/2021 |
Sterility |
14-570 |
Complete |
USP-NF |
M98830_02_01 |
<85> Bacterial Endotoxins Test |
07/06/2020 |
Sterility |
14-542 |
Complete |
ISO ASTM |
52628 Second edition 2020-04 |
Standard practice for dosimetry in radiation processing |
01/27/2015 |
Sterility |
14-390 |
Complete |
ISO |
14644-10 First edition 2013-03-01 |
Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration |
07/06/2020 |
Sterility |
14-540 |
Complete |
ISO |
11737-2 Third edition 2019-12 |
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
ANSI AAMI ISO |
11737-2:2019 |
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
12/20/2021 |
Sterility |
14-565 |
Complete |
USP-NF |
M98802_01_01 |
<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms |
07/06/2020 |
Sterility |
14-545 |
Complete |
ISO ASTM |
51276 Fourth edition 2019-08 |
Practice for use of a polymethylmethacrylate dosimetry system |
12/21/2020 |
Sterility |
14-554 |
Complete |
ASTM |
F17-20 |
Standard Terminology Relating to Flexible Barrier Packaging |
01/30/2014 |
Sterility |
14-395 |
Complete |
ISO |
14698-2 First edition 2003-09-15 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)] |
07/06/2020 |
Sterility |
14-549 |
Complete |
ASTM |
F3004-13 (Reapproved 2020) |
Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound |
07/15/2019 |
Sterility |
14-528 |
Complete |
ISO |
11137-1 First edition 2006-04-15 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)] |
ANSI AAMI ISO |
11137-1:2006/(R)2015 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)] |
12/19/2022 |
Sterility |
14-580 |
Complete |
ISO |
11137-2 Third edition 2013-06 [Including AMD1:2022] |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)] |
07/15/2019 |
Sterility |
14-533 |
Complete |
ISO |
TS 19930 First edition 2017-12 |
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
04/04/2016 |
Sterility |
14-340 |
Complete |
ISO |
20857 First edition 2010-08-15 |
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
ANSI AAMI ISO |
20857:2010/(R)2015 |
(Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
05/30/2022 |
Sterility |
14-577 |
Complete |
ISO |
11737-1 Third edition 2018-01 [Including AMD1:2021] |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)] |
04/04/2016 |
Sterility |
14-333 |
Complete |
ISO |
17665-1 First edition 2006-08-15 |
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
ANSI AAMI ISO |
17665-1:2006/(R)2013 |
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices |
07/15/2019 |
Sterility |
14-532 |
Complete |
ASTM |
F3287-17e1 |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method |
05/30/2022 |
Sterility |
14-578 |
Partial |
ISO |
17664-1 First edition 2021-07 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices |
08/14/2015 |
Sterility |
14-460 |
Partial |
ISO |
11140-1 Third edition 2014-11-01 |
Sterilization of health care products - Chemical indicators - Part 1: General requirements |
ANSI AAMI ISO |
11140-1:2014 |
Sterilization of health care products - Chemical indicators - Part 1: General requirements |
05/30/2022 |
Sterility |
14-572 |
Partial |
ANSI AAMI |
ST91:2021 |
Flexible and semi-rigid endoscope processing in health care facilities |
01/30/2014 |
Sterility |
14-334 |
Partial |
ISO |
15882 Second edition 2008-09-01 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results |
ANSI AAMI ISO |
15882:2008/(R)2013 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results |
01/30/2014 |
Sterility |
14-336 |
Partial |
ISO |
14161 Second edition 2009-09-15 |
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results |
ANSI AAMI ISO |
14161-2009/(R)2014 |
Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results |
01/30/2014 |
Sterility |
14-413 |
Complete |
AOAC |
6.2.06:2013 |
Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method |
01/14/2019 |
Sterility |
14-396 |
Partial |
ANSI AAMI |
ST77:2013/(R)2018 |
Containment devices for reusable medical device sterilization |
12/23/2016 |
Sterility |
14-500 |
Complete |
ISO |
14644-1 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration |
12/21/2020 |
Sterility |
14-551 |
Complete |
ISO |
14160 Third edition 2020-09 |
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
09/09/2008 |
Software/ Informatics |
13-19 |
Complete |
CLSI |
LIS04-A |
Standard Guide for Documentation of Clinical Laboratory Computer Systems |
07/06/2020 |
Software/ Informatics |
13-114 |
Complete |
IEEE |
Std 11073-10101-2019 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
07/06/2020 |
Software/ Informatics |
13-115 |
Complete |
ISO IEC IEEE |
29119-1 First edition 2013-09-01 |
Software and systems engineering - Software testing - Part 1: Concepts and definitions |
01/14/2019 |
Software/ Informatics |
13-106 |
Complete |
IEEE |
Std 11073-10207-2017 |
Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication |
06/27/2016 |
Software/ Informatics |
13-84 |
Complete |
ISO IEEE |
11073-10103 First edition 2014-03-01 |
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |
09/09/2008 |
Software/ Informatics |
13-18 |
Complete |
CLSI |
LIS03-A |
Standard Guide for Selection of a Clinical Laboratory Information Management System |
08/21/2017 |
Software/ Informatics |
13-94 |
Complete |
ISO IEEE |
11073-10424 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)] |
08/06/2013 |
Software/ Informatics |
13-49 |
Complete |
ISO IEEE |
11073-20101 First edition 2004-12-15 |
Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard |
08/06/2013 |
Software/ Informatics |
13-55 |
Complete |
IEEE |
Std 11073-10421-2010 |
Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
01/14/2019 |
Software/ Informatics |
13-105 |
Complete |
ANSI AAMI |
SW91:2018 |
Classification of defects in health software |
08/06/2013 |
Software/ Informatics |
13-56 |
Complete |
IEEE |
Std 11073-10406-2011 |
Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph |
08/21/2017 |
Software/ Informatics |
13-67 |
Complete |
ISO IEEE |
11073-10418 First edition 2014-03-01 |
Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)] |
01/14/2019 |
Software/ Informatics |
13-79 |
Complete |
IEC |
62304 Edition 1.1 2015-06 CONSOLIDATED VERSION |
Medical device software - Software life cycle processes |
ANSI AAMI IEC |
62304:2006/A1:2016 |
Medical device software - Software life cycle processes [Including Amendment 1 (2016)] |
12/23/2019 |
Software/ Informatics |
13-111 |
Complete |
IEEE |
Std 11073-10201-2018 |
Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model |
08/21/2017 |
Software/ Informatics |
13-96 |
Complete |
UL ANSI |
2900-1 First Edition 2017 |
Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements |
12/23/2016 |
Software/ Informatics |
13-87 |
Complete |
ISO IEC |
15026-2 First edition 2011-02-15 |
Systems and software engineering - Systems and software assurance - Part 2: Assurance case |
07/15/2019 |
Software/ Informatics |
13-108 |
Complete |
IEEE |
Std 11073-20701-2018 |
Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding |
12/19/2022 |
Software/ Informatics |
13-123 |
Complete |
ANSI NEMA |
HN 1-2019 |
American National Standard Manufacturer Disclosure Statement for Medical Device Security |
08/06/2013 |
Software/ Informatics |
13-38 |
Complete |
IEC |
80001-1 Edition 1.0 2010-10 |
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
ANSI AAMI IEC |
80001-1:2010 |
Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
12/23/2019 |
Software/ Informatics |
13-112 |
Complete |
AAMI |
TIR97:2019 |
Principles for medical device security - Postmarket risk management for device manufacturers |
04/04/2016 |
Software/ Informatics |
13-81 |
Complete |
IEEE |
Std 11073-10419:2015 |
Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump |
08/21/2017 |
Software/ Informatics |
13-91 |
Complete |
ISO IEEE |
11073-10419 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump |
07/09/2014 |
Software/ Informatics |
13-68 |
Complete |
ISO |
11073-90101 First edition 2008-01-15 |
Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test |
08/14/2015 |
Software/ Informatics |
13-76 |
Complete |
ISO |
11073-91064 First edition 2009-05-01 |
Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
08/06/2013 |
Software/ Informatics |
13-59 |
Complete |
ISO IEC IEEE |
15026-4 First edition 2021-10-01 |
Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle |
12/04/2017 |
Software/ Informatics |
13-99 |
Complete |
ISO IEC |
15459-2 Third edition 2015-03-01 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures |
07/06/2020 |
Software/ Informatics |
13-113 |
Complete |
IEEE |
Std 11073-20601-2019 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol. |
01/14/2019 |
Software/ Informatics |
13-107 |
Complete |
ISO |
11073-20702 First edition 2018-09 |
Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services |
IEEE |
Std 11073-20702-2016 |
Health informatics - Point-of-care medical device communication Part 20702: Medical Devices |
08/14/2015 |
Software/ Informatics |
13-77 |
Complete |
ISO IEC |
29147 First edition 2014-02-15 |
Information technology - Security techniques - Vulnerability disclosure |
10/19/2020 |
Software/ Informatics |
13-116 |
Complete |
FIRST |
CVSS v3.0 |
Common Vulnerability Scoring System version 3.0 |
12/19/2022 |
Software/ Informatics |
13-128 |
Complete |
IEEE UL |
Std 2621.2-2022 |
Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions |
12/23/2016 |
Software/ Informatics |
13-86 |
Complete |
ISO IEC |
15026-1 First edition 2013-11-01 |
Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary |
08/06/2013 |
Software/ Informatics |
13-40 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-1 2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples |
IEC |
TR 80001-2-1 Edition 1.0 2012-07 |
Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples |
08/06/2013 |
Software/ Informatics |
13-44 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-3:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
IEC |
TR 80001-2-3 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
08/21/2017 |
Software/ Informatics |
13-97 |
Complete |
IEC |
82304-1 Edition 1.0 2016-10 |
Health software - Part 1: General requirements for product safety |
01/30/2014 |
Software/ Informatics |
13-63 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-4:2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations |
IEC |
TR 80001-2-4 Edition 1.0 2012-11 |
Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization |
12/04/2017 |
Software/ Informatics |
13-102 |
Complete |
IEC |
TR 80001-2-8 Edition 1.0 2016-05 |
Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 |
12/04/2017 |
Software/ Informatics |
13-101 |
Complete |
ISO IEC |
15459-6 Second edition 2014 Corrected 2016 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings |
08/06/2013 |
Software/ Informatics |
13-52 |
Complete |
ISO IEEE |
11073-10408 First edition 2010-05-01 |
Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer |
07/09/2014 |
Software/ Informatics |
13-69 |
Complete |
ISO IEEE |
11073-10472 First edition 2012-11-01 |
Health informatics - Personal health device communication -- Part 10472: Device specialization - Medication monitor |
08/21/2017 |
Software/ Informatics |
13-90 |
Complete |
IEEE |
Std 11073-10417-2015 |
Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter |
01/27/2015 |
Software/ Informatics |
13-70 |
Complete |
ANSI AAMI IEC |
TIR80001-2-5:2014 |
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems |
IEC |
TR 80001-2-5 Edition 1.0 2014-12 |
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems |
12/04/2017 |
Software/ Informatics |
13-100 |
Complete |
ISO IEC |
15459-4 Third edition 2014 Corrected 2016 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages |
08/14/2015 |
Software/ Informatics |
13-75 |
Complete |
ISO IEEE |
11073-10102 First edition 2014-03-01 |
Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG |
08/14/2015 |
Software/ Informatics |
13-78 |
Complete |
INCITS ISO IEC |
30111 First edition 2013-11-01 (R2019) |
Information technology - Security techniques - Vulnerability handling processes |
08/21/2017 |
Software/ Informatics |
13-89 |
Complete |
ISO IEEE |
11073-10406 First edition 2012-12-01 |
Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
12/04/2017 |
Software/ Informatics |
13-103 |
Complete |
IEC |
TR 80001-2-9 Edition 1.0 2017-01 |
Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities |
01/15/2013 |
Software/ Informatics |
13-34 |
Complete |
ANSI AAMI IEC |
TIR80002-1:2009 |
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
IEC |
TR 80002-1 Edition 1.0 2009-09 |
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
09/09/2008 |
Software/ Informatics |
13-20 |
Complete |
CLSI |
LIS05-A |
Standand Specification for Transferring Clinical Observations Between Independent Computer Systems |
09/09/2008 |
Software/ Informatics |
13-21 |
Complete |
CLSI |
LIS06-A |
Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems |
09/09/2008 |
Software/ Informatics |
13-22 |
Complete |
CLSI |
LIS07-A |
Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory |
09/09/2008 |
Software/ Informatics |
13-23 |
Complete |
CLSI |
LIS08-A |
Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems |
09/09/2008 |
Software/ Informatics |
13-24 |
Complete |
CLSI |
LIS09-A |
Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures |
09/08/2009 |
Software/ Informatics |
13-29 |
Complete |
CLSI |
LIS01-A2 |
Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems |
08/21/2017 |
Software/ Informatics |
13-95 |
Complete |
ISO IEEE |
11073-10425 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) |
12/19/2022 |
Software/ Informatics |
13-124 |
Complete |
AAMI |
CR34971:2022 |
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning |
12/19/2022 |
Software/ Informatics |
13-125 |
Complete |
ANSI AAMI UL |
2800-1-1:2022 |
Standard for Risk Concerns for Interoperable Medical Products |
10/09/2023 |
Software/ Informatics |
13-130 |
Complete |
ANSI AAMI |
2700-2-1:2022 |
Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging |
12/04/2017 |
Software/ Informatics |
13-98 |
Complete |
ISO IEC |
646 Third edition 1991-12-15 (R2018) |
Information technology - ISO 7-bit coded character set for information interchange |
INCITS ISO IEC |
646:1991 (R2018) |
Information technology - ISO 7-bit coded character set for information interchange |
08/06/2013 |
Software/ Informatics |
13-42 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-2:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
IEC |
TR 80001-2-2 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
01/15/2013 |
Software/ Informatics |
13-33 |
Complete |
AAMI |
TIR 36:2007 |
Validation of software for regulated processes |
07/09/2014 |
Software/ Informatics |
13-15 |
Complete |
CLSI |
AUTO13-A2 (Formerly GP19-A2) |
Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition |
01/15/2013 |
Software/ Informatics |
13-35 |
Complete |
ANSI AAMI |
SW87:2012 |
Application of quality management system concepts to medical device data systems |
08/06/2013 |
Software/ Informatics |
13-37 |
Complete |
CLSI |
AUTO7-A |
Laboratory Automation: Data Content for Specimen Identification; Approved Standard |
08/14/2015 |
Software/ Informatics |
13-74 |
Complete |
IEEE |
Std 11073-10424-2014 |
Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) |
08/21/2017 |
Software/ Informatics |
13-88 |
Complete |
ISO IEEE |
11073-10417 Third edition 2017-04 |
Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter |
08/21/2017 |
Software/ Informatics |
13-93 |
Complete |
IEEE |
Std 11073-10422-2016 |
Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer |
08/06/2013 |
Software/ Informatics |
13-53 |
Complete |
ISO IEEE |
11073-10415 First edition 2010-05-01 |
Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale |
10/09/2023 |
Software/ Informatics |
13-129 |
Complete |
ISO IEC IEEE |
29119-1 Second edition 2022-01 |
Software and systems engineering - Software testing - Part 1: General concepts |
06/27/2016 |
Software/ Informatics |
13-82 |
Complete |
ANSI AAMI ISO |
TIR 80001-2-6:2014 |
Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements |
06/27/2016 |
Software/ Informatics |
13-83 |
Complete |
AAMI |
TIR57:2016 |
Principles for medical device security - Risk management. |
10/09/2023 |
Software/ Informatics |
13-131 |
Complete |
ANSI AAMI |
SW96:2023 |
Standard for medical device security - Security risk management for device manufacturers |
01/15/2013 |
Software/ Informatics |
13-36 |
Complete |
AAMI |
TIR 45:2012 |
Guidance on the use of AGILE practices in the development of medical device software |
12/23/2016 |
Software/ Informatics |
13-85 |
Complete |
CLSI |
AUTO11-A2 |
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition |
03/18/2009 |
Software/ Informatics |
13-25 |
Complete |
CLSI |
AUTO8-A |
Managing and Validating Laboratory Information Systems; Approved Guideline |
03/18/2009 |
Software/ Informatics |
13-26 |
Complete |
CLSI |
AUTO10-A |
Autoverification of Clinical Laboratory Test Results; Approved Guideline |
03/18/2009 |
Software/ Informatics |
13-28 |
Complete |
CLSI |
AUTO9-A |
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
08/06/2013 |
Software/ Informatics |
13-61 |
Complete |
IEC |
62443-2-1 Edition 1.0 2010-11 |
Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program |
12/19/2022 |
Software/ Informatics |
13-126 |
Complete |
ANSI AAMI UL |
2800-1-2:2022 |
Standard for Interoperable Item Development Life Cycle |
12/19/2022 |
Software/ Informatics |
13-127 |
Complete |
ANSI AAMI UL |
2800-1-3:2022 |
Standard for Interoperable Item Integration Life Cycle |
12/19/2022 |
Software/ Informatics |
13-121 |
Complete |
ANSI AAMI UL |
2800-1:2022 |
Standard for Medical Device Interoperability |
06/07/2018 |
Software/ Informatics |
13-104 |
Complete |
UL ANSI |
2900-2-1 First Edition 2017 |
Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems |
08/06/2013 |
Software/ Informatics |
13-57 |
Complete |
ISO IEEE |
11073-10407 First edition 2010-05-01 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
09/09/2008 |
Software/ Informatics |
13-9 |
Complete |
CLSI |
AUTO2-A2 |
Laboratory Automation: Bar Codes for Specimen Container Identification |
09/09/2008 |
Software/ Informatics |
13-10 |
Complete |
CLSI |
AUTO1-A |
Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard |
09/09/2008 |
Software/ Informatics |
13-12 |
Complete |
CLSI |
AUTO4-A |
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard |
09/09/2008 |
Software/ Informatics |
13-13 |
Complete |
CLSI |
AUTO5-A |
Laboratory Automation: Electromechanical Interfaces; Approved Standard |
09/09/2008 |
Software/ Informatics |
13-14 |
Complete |
CLSI |
POCT1-A2 |
Point-of-Care Connectivity |
09/09/2008 |
Software/ Informatics |
13-17 |
Complete |
CLSI |
LIS02-A2 |
Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition |
01/27/2015 |
Software/ Informatics |
13-72 |
Complete |
IEEE |
Std 11073-10425-2014 |
Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM) |
07/09/2014 |
Software/ Informatics |
13-65 |
Complete |
UL ANSI |
1998 Third Edition 2013 |
Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008] |
03/16/2012 |
Software/ Informatics |
13-30 |
Complete |
CLSI |
AUTO3-A2 |
Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard |
08/20/2012 |
Software/ Informatics |
13-31 |
Complete |
CLSI |
AUTO12-A |
Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard |
08/06/2013 |
Software/ Informatics |
13-60 |
Complete |
IEC |
TS 62443-1-1 Edition 1.0 2009-07 |
Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models |
08/06/2013 |
Software/ Informatics |
13-62 |
Complete |
IEC |
TR 62443-3-1 Edition 1.0 2009-07 |
Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems |
06/07/2021 |
Software/ Informatics |
13-119 |
Complete |
ANSI ISA |
62443-4-1-2018 |
Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements. |
12/19/2022 |
Software/ Informatics |
13-122 |
Complete |
IEC |
81001-5-1 Edition 1.0 2021-12 |
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
|
06/07/2021 |
Software/ Informatics |
13-118 |
Complete |
IEEE |
Std 11073-40102:2020 |
Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation. |
12/20/2021 |
Software/ Informatics |
13-120 |
Complete |
ANSI AAMI |
2700-1:2019 |
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
08/21/2017 |
Software/ Informatics |
13-92 |
Partial |
ISO IEEE |
11073-10421 First edition 2012-11-01 |
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
08/06/2013 |
Software/ Informatics |
13-54 |
Partial |
ISO IEEE |
11073-10404 First edition 2010-05-01 |
Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter |
01/27/2015 |
Software/ Informatics |
13-71 |
Partial |
RII |
Version 2.48 |
Logical Observation Identifiers Names and Codes (LOINC) |
06/07/2021 |
Software/ Informatics |
13-117 |
Partial |
IEEE |
Std 11073-40101-2020 |
Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment. |
08/14/2015 |
Software/ Informatics |
13-73 |
Partial |
IHTSDO |
SNOMED-CT RF2 Release 2015 |
Systematized Nomenclature of Medicine - Clinical Terms |
05/30/2022 |
Radiology |
12-343 |
Complete |
IEC |
62127-1 Edition 2.0 2022-03 |
Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields |
07/15/2019 |
Radiology |
12-326 |
Complete |
NEMA |
NU 2-2018 |
Performance Measurements of Positron Emission Tomographs |
07/06/2020 |
Radiology |
12-331 |
Complete |
NEMA |
Standards Publication MS 14-2019 |
Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems |
03/31/2006 |
Radiology |
12-136 |
Complete |
ISO |
9236-1 Second edition 2004-02-01 |
Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient |
08/14/2015 |
Radiology |
12-291 |
Complete |
IEC |
62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
06/07/2021 |
Radiology |
12-340 |
Complete |
IEC |
60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment |
08/06/2013 |
Radiology |
12-205 |
Complete |
IEC |
60601-2-5: Edition 3.0 2009-07 |
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
12/20/2021 |
Radiology |
12-341 |
Complete |
IEC |
62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION |
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods |
03/16/2012 |
Radiology |
12-232 |
Complete |
NEMA |
MS 4-2010 |
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
03/16/2012 |
Radiology |
12-242 |
Complete |
IEC |
60601-2-57 Edition 1.0 2011-01 |
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
09/09/2008 |
Radiology |
12-165 |
Complete |
NEMA |
XR 22-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography |
07/09/2014 |
Radiology |
12-282 |
Complete |
ISO |
12609-1 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
12/19/2007 |
Radiology |
12-172 |
Complete |
ISO |
14880-3:2006 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
12/19/2007 |
Radiology |
12-173 |
Complete |
ISO |
14880-4:2006 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
12/19/2007 |
Radiology |
12-176 |
Complete |
IEC |
61223-3-2 Second eidtion 2007-07 |
Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
05/30/2022 |
Radiology |
12-345 |
Complete |
IEC |
61223-3-7 Edition 1.0 2021-12 |
Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography |
07/09/2014 |
Radiology |
12-272 |
Complete |
IEC |
60601-2-17 Edition 3.0 2013-11 |
Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment |
01/30/2014 |
Radiology |
12-266 |
Complete |
IEC |
61689 Edition 3.0 2013-02 |
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz |
08/14/2015 |
Radiology |
12-292 |
Complete |
IEEE |
Std 3333.2.1-2015 |
IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling |
03/31/2006 |
Radiology |
12-141 |
Complete |
IEEE |
N42.13-2004 |
Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides |
04/04/2016 |
Radiology |
12-196 |
Complete |
NEMA |
MS 2-2008 (R2020) |
Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images |
06/07/2018 |
Radiology |
12-314 |
Complete |
ISO |
11554 Fourth edition 2017-07 |
Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics |
08/14/2015 |
Radiology |
12-289 |
Complete |
IEC |
62220-1-1 Edition 1.0 2015-03 |
Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging |
03/14/2011 |
Radiology |
12-221 |
Complete |
IEC |
61223-3-4 First edition 2000-03 |
Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray |
03/16/2012 |
Radiology |
12-142 |
Complete |
ISO |
11146-2 First edition 2005-02-15 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams |
03/16/2012 |
Radiology |
12-143 |
Complete |
ISO |
15367-2 First edition 2005-03-15 |
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors |
03/16/2012 |
Radiology |
12-248 |
Complete |
ISO |
21254-3 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities |
03/16/2012 |
Radiology |
12-174 |
Complete |
ISO |
13697 First edition 2006-05-15 |
Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components |
01/14/2014 |
Radiology |
12-268 |
Complete |
IEC |
60601-2-22 Edition 3.1 2012-10 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
07/09/2014 |
Radiology |
12-279 |
Complete |
IEC |
62127-03 Edition 1.1 2013-05 |
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz |
03/31/2006 |
Radiology |
12-137 |
Complete |
ISO |
4090 Third eidition 2001-08-15 |
Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications |
03/31/2006 |
Radiology |
12-138 |
Complete |
ISO |
5799 Second edition 1991-08-01 |
Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient |
10/04/2004 |
Radiology |
12-116 |
Complete |
ISO |
13696:2002 |
Optics and optical instruments -- Test methods for radiation scattered by optical components |
01/30/2014 |
Radiology |
12-259 |
Complete |
IEC |
61674 Edition 2.0 2012-11 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
07/09/2014 |
Radiology |
12-194 |
Complete |
ANSI HPS |
N43.6-2007 (R2013) |
Sealed Radioactive Sources - Classification |
03/16/2012 |
Radiology |
12-134 |
Complete |
ISO |
11146-1 First edition 2005-01-15 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams |
06/27/2016 |
Radiology |
12-297 |
Complete |
ANSI IES |
RP-27.1-2015 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements |
06/27/2016 |
Radiology |
12-298 |
Complete |
NEMA |
MS 10-2010 |
Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging |
01/14/2019 |
Radiology |
12-323 |
Complete |
ISO |
11990 Third edition 2018-08 |
Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs |
01/30/2014 |
Radiology |
12-262 |
Complete |
ISO |
11670 Second edition 2003-04-01 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)] |
04/04/2016 |
Radiology |
12-288 |
Complete |
NEMA |
MS 9-2008 (R2020) |
Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images |
07/12/1999 |
Radiology |
12-51 |
Complete |
IEC |
61145 (1992-05) |
Calibration and usage of ionization chamber systems for assay of radionuclides |
08/21/2017 |
Radiology |
12-306 |
Complete |
NEMA |
MS 12-2016 |
Quantification and Mapping of Geometric Distortion for Special Applications |
08/20/2012 |
Radiology |
12-249 |
Complete |
IEC |
62471 First edition 2006-07 |
Photobiological safety of lamps and lamp systems |
07/06/2020 |
Radiology |
12-330 |
Complete |
NEMA |
Standards Publication XR 28-2018 |
Supplemental Requirements for User Information and System Function Related to Dose in CT |
03/14/2011 |
Radiology |
12-217 |
Complete |
IEC |
62083 Edition 2.0 2009-09 |
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
03/16/2012 |
Radiology |
12-117 |
Complete |
ISO |
15367-1 First edition 2003-09-15 |
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects |
06/07/2021 |
Radiology |
12-337 |
Complete |
NEMA |
NU 1-2018 |
Performance Measurements of Gamma Cameras |
03/16/2012 |
Radiology |
12-246 |
Complete |
ISO |
21254-2 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: Threshold determination |
03/16/2012 |
Radiology |
12-245 |
Complete |
ISO |
21254-1 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles |
10/04/2010 |
Radiology |
12-215 |
Complete |
IEC |
62494-1 Edition 1.0 (2008-08) |
Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
03/16/2012 |
Radiology |
12-106 |
Complete |
ISO |
17526 First edition 2003-06-15 |
Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers |
08/06/2013 |
Radiology |
12-211 |
Complete |
IEC |
60601-2-29 Edition 3.0 2008-06 |
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators |
06/07/2021 |
Radiology |
12-336 |
Complete |
IEC |
60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
06/27/2016 |
Radiology |
12-293 |
Complete |
IEC |
60601-2-37 Edition 2.1 2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
09/17/2018 |
Radiology |
12-318 |
Complete |
IEC |
60601-2-64 Edition 1.0 2014-09 |
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment |
09/17/2018 |
Radiology |
12-320 |
Complete |
IEC |
62667 Edition 1.0 2017-08 |
Medical electrical equipment - Medical light ion beam equipment - Performance characteristics |
12/04/2017 |
Radiology |
12-307 |
Complete |
AAMI |
RT2:2017 |
Radiation therapy readiness check |
05/29/2023 |
Radiology |
12-350 |
Complete |
IEC |
60806 Edition 2.0 2022-11 |
Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis |
06/27/2016 |
Radiology |
12-294 |
Complete |
IEC |
60601-2-45 Edition 3.1 2015 |
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
06/27/2016 |
Radiology |
12-301 |
Complete |
IEC |
60601-2-8 Edition 2.1 b:2015 |
Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
11/08/2005 |
Radiology |
12-6 |
Complete |
IEC |
60806 First edition 1984-01 |
Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis |
04/04/2016 |
Radiology |
12-188 |
Complete |
NEMA |
MS-1-2008 (R2020) |
Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging |
04/04/2016 |
Radiology |
12-187 |
Complete |
NEMA |
MS 3-2008 (R2020) |
Determination of Image Uniformity in Diagnostic Magnetic Resonance Images |
01/30/2014 |
Radiology |
12-59 |
Complete |
IEC |
61168:1993 |
Radiotherapy simulators - Functional performance characteristics |
01/30/2014 |
Radiology |
12-264 |
Complete |
NEMA |
MS 11-2010 |
Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging |
06/07/2018 |
Radiology |
12-312 |
Complete |
IEC |
61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION |
Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response |
06/07/2018 |
Radiology |
12-313 |
Complete |
IEC |
TS 62462 Edition 2.0 2017-07 |
Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems |
12/19/2007 |
Radiology |
12-171 |
Complete |
ISO |
14880-2:2006 |
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations |
03/16/2012 |
Radiology |
12-175 |
Complete |
ISO |
24013 First edition 2006-11-15 |
Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation |
06/07/2018 |
Radiology |
12-315 |
Complete |
NEMA |
MS 8-2016 |
Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems |
12/23/2019 |
Radiology |
12-329 |
Complete |
IEC |
60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
12/19/2022 |
Radiology |
12-349 |
Complete |
NEMA |
PS 3.1 - 3.20 2022d |
Digital Imaging and Communications in Medicine (DICOM) Set |
12/18/2023 |
Radiology |
12-352 |
Complete |
NEMA |
PS 3.1 - 3.20 2023e |
Digital Imaging and Communications in Medicine (DICOM) Set |
05/29/2023 |
Radiology |
12-351 |
Complete |
IEC |
60601-2-43 Edition 3.0 2022-12 |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
01/27/2015 |
Radiology |
12-230 |
Complete |
NEMA |
XR 24-2008 (R2014) |
Primary user controls for interventional angiography x-ray equipment |
01/27/2015 |
Radiology |
12-286 |
Complete |
NEMA |
XR 27 Amendment 1-2013 |
X-ray equipment for interventional procedures - User Quality Control Mode |
01/14/2019 |
Radiology |
12-322 |
Complete |
NEMA |
MS 5-2018 |
Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging |
05/29/2023 |
Radiology |
12-347 |
Complete |
IEC |
60601-2-33 Edition 4.0 2022-08 |
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
05/27/2005 |
Radiology |
12-121 |
Complete |
IEC |
61847: 1998 |
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0 |
12/23/2019 |
Radiology |
12-309 |
Complete |
IEC |
60601-2-28 Edition 3.0 2017-06 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
12/23/2019 |
Radiology |
12-327 |
Complete |
ISO |
11551 Third eidtion 2019-10 |
Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components |
12/19/2022 |
Radiology |
12-346 |
Complete |
ISO |
12005 Third edition 2022-05 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization |
01/14/2019 |
Radiology |
12-102 |
Complete |
ANSI IES |
RP-27.2-00/R17 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques |
01/14/2019 |
Radiology |
12-321 |
Complete |
ANSI IES |
RP-27.3-17 |
Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling |
07/06/2020 |
Radiology |
12-332 |
Complete |
IEC |
62464-1 Edition 2.0 2018-12 |
Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters. |
07/06/2020 |
Radiology |
12-334 |
Complete |
AAMI |
RT3:2020 |
Radiation therapy machine characterization |
07/06/2020 |
Radiology |
12-325 |
Complete |
NEMA |
Standards Publication XR 25 -2019 |
Computed Tomography Dose Check |
03/16/2012 |
Radiology |
12-177 |
Complete |
UL |
122-2007 (R2011) |
Standard for Photographic Equipment - Ed. 5.0 |
01/30/2014 |
Radiology |
12-228 |
Complete |
IEC |
61391-2 Edition 1.0 2010-01 |
Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
03/14/2011 |
Radiology |
12-226 |
Complete |
IEC |
61223-2-6 Second Edition 2006-11 |
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment |
07/09/2014 |
Radiology |
12-275 |
Complete |
IEC |
61161 Edition 3.0 2013-01 |
Ultrasonics -- Power measurement -- Radiation force balances and performance requirements |
07/09/2014 |
Radiology |
12-280 |
Complete |
IEC |
62555 Edition 1.0 2013-11 |
Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems |
07/09/2014 |
Radiology |
12-281 |
Complete |
IEC |
60601-2-62 Edition 1.0 2013-07 |
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
03/16/2012 |
Radiology |
12-115 |
Complete |
ISO |
13695:2004 |
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
12/23/2016 |
Radiology |
12-303 |
Complete |
IEC |
61303 Edition 1.0 1994-09 |
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)] |
12/23/2016 |
Radiology |
12-304 |
Complete |
IEC |
60731 Edition 3.1 2016-04 |
Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
03/16/2012 |
Radiology |
12-241 |
Complete |
IEC |
62274 First Edition 2005-05 |
Medical electrical equipment - Safety of radiotherapy record and verify systems |
08/06/2013 |
Radiology |
12-253 |
Complete |
IEC |
60976 Edition 2.0 2007-10 |
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
08/06/2013 |
Radiology |
12-255 |
Complete |
IEC |
60601-2-11 Edition 3.0 2013-01 |
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
09/09/2008 |
Radiology |
12-166 |
Complete |
NEMA |
XR 23-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography |
10/04/2010 |
Radiology |
12-213 |
Complete |
IEC |
62220-1-2 Edition 1.0 2007-06 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography |
10/04/2010 |
Radiology |
12-214 |
Complete |
IEC |
62220-1-3 Edition 1.0 2008-06 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging |
07/09/2014 |
Radiology |
12-283 |
Complete |
ISO |
12609-2 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use |
08/14/2015 |
Radiology |
12-290 |
Complete |
IEC |
61910-1 Edition 1.0 2014-09 |
Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
06/07/2018 |
Radiology |
12-316 |
Complete |
IEC |
62359 Edition 2.1 2017-09 CONSOLIDATED VERSION |
Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
12/23/2019 |
Radiology |
12-328 |
Complete |
IEC |
61223-3-5 Edition 2.0 2019-09 |
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)] |
01/14/2019 |
Radiology |
12-324 |
Complete |
ISO |
13694 Third edition 2018-11 |
Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution |
09/17/2018 |
Radiology |
12-319 |
Complete |
IEC |
60601-2-68 Edition 1.0 2014-09 |
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
07/06/2020 |
Radiology |
12-333 |
Complete |
IEC |
TR 63183 Edition 1.0 2019-12 |
Guidance on error and warning messages for software used in radiotherapy |
06/07/2021 |
Radiology |
12-339 |
Complete |
IEC |
60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
05/30/2022 |
Radiology |
12-344 |
Complete |
IEC |
62563-2 Edition 1.0 2021-11 |
Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays |
06/27/2016 |
Radiology |
12-295 |
Partial |
IEC |
60601-2-33 Ed. 3.2 b:2015 |
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
12/18/2023 |
Radiology |
12-348 |
Partial |
IEC |
60601-2-54 Edition 2.0 2022-09 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
12/18/2023 |
Radiology |
12-353 |
Partial |
ANSI |
Z136.1-2022 |
American National Standard for Safe Use of Lasers |
06/27/2016 |
Radiology |
12-302 |
Partial |
IEC |
60601-2-44 Edition 3.2: 2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography |
01/30/2014 |
Radiology |
12-261 |
Complete |
ISO IEC |
10918-1 First edition 1994-02-15 |
Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)] |
01/30/2014 |
Radiology |
12-267 |
Complete |
IEC |
61217 Edition 2.0 2011-12 |
Radiotherapy equipment - Coordinates, movements, and scales |
04/04/2016 |
Radiology |
12-195 |
Complete |
NEMA |
MS 6-2008 (R2014, R2020) |
Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging |
07/09/2014 |
Radiology |
12-273 |
Complete |
IEC |
60825-1 Edition 2.0 2007-03 |
Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)] |
03/16/2012 |
Radiology |
12-105 |
Complete |
NEMA |
UD 2-2004 (R2009) |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
06/07/2021 |
Radiology |
12-338 |
Complete |
IEC |
60601-2-1 Edition 4.0 2020-10 |
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
06/07/2021 |
Radiology |
12-335 |
Complete |
IEC |
60336 Edition 5.0 2020-12 |
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics |
06/07/2021 |
Physical Medicine |
16-231 |
Complete |
ISO |
10328 Second edition 2016-06-01 |
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods |
12/23/2019 |
Physical Medicine |
16-215 |
Complete |
RESNA ANSI |
WC-2:2019 Section 9 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for Eeectrically powered wheelchairs |
12/23/2019 |
Physical Medicine |
16-228 |
Complete |
RESNA ANSI |
WC-4:2017 Section 19 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 19: Wheelchairs used as seats in motor vehicles. |
12/23/2019 |
Physical Medicine |
16-226 |
Complete |
RESNA ANSI |
WC-4:2017 Section 10 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transporation Section 10 Wheelchair and occupant retention systems for use in large accessible transit vehicles: systems for rearward-facing passengers. |
07/15/2019 |
Physical Medicine |
16-206 |
Complete |
ISO |
7176 - 30 First edition 2018-12 |
Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements |
05/29/2023 |
Physical Medicine |
16-234 |
Complete |
ISO |
7176-14 Third Edition 2022 |
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods |
08/14/2015 |
Physical Medicine |
16-194 |
Complete |
ISO |
7176-25 First edition 2013-07-15 |
Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs |
01/30/2014 |
Physical Medicine |
16-165 |
Complete |
ISO |
7176-14 Second edition 2008-02-15 |
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods |
05/29/2023 |
Physical Medicine |
16-235 |
Complete |
ISO |
7176-25 Second Edition 2022 |
Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods |
05/29/2023 |
Physical Medicine |
16-236 |
Complete |
ISO |
7176-19 Third Edition 2022 |
Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles |
04/04/2016 |
Physical Medicine |
16-195 |
Complete |
ISO |
7176-1 Third edition 2014-10-01 |
Wheelchairs - Part 1: Determination of static stability |
01/30/2014 |
Physical Medicine |
16-164 |
Complete |
ISO |
7176-10 Second edition 2008-11-01 |
Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
12/23/2016 |
Physical Medicine |
16-199 |
Complete |
ISO |
7176-28 First edition 2012-10-1 |
Wheelchairs Part 28: Requirements and test methods for stairclimbing devices |
12/23/2019 |
Physical Medicine |
16-212 |
Complete |
RESNA ANSI |
WC-2:2019 Section 6 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically powered wheelchairs. |
09/17/2018 |
Physical Medicine |
16-203 |
Complete |
ASME |
A18.1-2017 |
Safety Standard for Platform Lifts and Stairway Chairlifts |
12/19/2022 |
Physical Medicine |
16-233 |
Complete |
ISO |
16840-10 Second edition 2021-06 Corrected version 2022-01 |
Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method |
04/04/2016 |
Physical Medicine |
16-196 |
Complete |
ISO |
7176-7 First Edition 1998-05-15 |
Wheelchairs - Part 7: Measurement of seating and wheel dimensions |
06/07/2018 |
Physical Medicine |
16-201 |
Complete |
ISO |
7176-19 Second Edition 2008-07-15 |
Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)] |
04/04/2016 |
Physical Medicine |
16-197 |
Complete |
ISO |
7176-8 Second editon 2014-12-15 |
Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths |
04/04/2016 |
Physical Medicine |
16-198 |
Complete |
ISO |
7176-22 Second edition 2014-09-01 |
Wheelchairs - Part 22: Set-up procedures |
01/30/2014 |
Physical Medicine |
16-167 |
Complete |
ISO |
7176-9 Third edition 2009-11-15 |
Wheelchairs - Part 9: Climatic tests for electric wheelchairs |
12/23/2019 |
Physical Medicine |
16-208 |
Complete |
RESNA ANSI |
WC-2:2019 Section 2 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs |
09/17/2018 |
Physical Medicine |
16-202 |
Complete |
ISO |
7176-2 Third edition 2017-10 |
Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs |
08/06/2013 |
Physical Medicine |
16-190 |
Complete |
ISO |
7176-11 Second edition 2012-12-01 |
Wheelchairs - Part 11: Test dummies |
08/06/2013 |
Physical Medicine |
16-192 |
Complete |
ISO |
7176-3 Third edition 2012-12-15 |
Wheelchairs - Part 3: Determination of effectiveness of brakes |
01/30/2014 |
Physical Medicine |
16-25 |
Complete |
ISO |
7176-13 First edition 1989-08-01 |
Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces |
01/30/2014 |
Physical Medicine |
16-162 |
Complete |
ISO |
7176-4 Third edition 2008-10-01 |
Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range |
01/14/2019 |
Physical Medicine |
16-204 |
Complete |
ISO |
7176-6 Third edition 2018-06 |
Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs |
12/20/2021 |
Physical Medicine |
16-232 |
Complete |
IEC |
80601-2-78 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
12/23/2019 |
Physical Medicine |
16-223 |
Complete |
RESNA ANSI |
WC-1:2019 Section 22 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures |
12/23/2019 |
Physical Medicine |
16-224 |
Complete |
RESNA ANSI |
WC-2:2019 Section 21 |
American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters |
12/23/2019 |
Physical Medicine |
16-211 |
Complete |
RESNA ANSI |
WC-1:2019 Section 5 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space |
12/23/2019 |
Physical Medicine |
16-219 |
Complete |
RESNA ANSI |
WC-2:2019 Section 14 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods |
12/23/2019 |
Physical Medicine |
16-213 |
Complete |
RESNA ANSI |
WC-1:2019 Section 7 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions |
12/23/2019 |
Physical Medicine |
16-214 |
Complete |
RESNA ANSI |
WC-1:2019 Section 8 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, Iipact and fatigue strengths |
01/30/2014 |
Physical Medicine |
16-27 |
Complete |
ISO |
7176-15 First edition 1996-11-15 |
Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling |
01/30/2014 |
Physical Medicine |
16-163 |
Complete |
ISO |
7176-5 Second edition 2008-06-01 |
Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space |
12/23/2019 |
Physical Medicine |
16-225 |
Complete |
RESNA ANSI |
WC-1:2019 Section 26 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary |
12/23/2019 |
Physical Medicine |
16-216 |
Complete |
RESNA ANSI |
WC-2:2019 Section 10 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
12/23/2019 |
Physical Medicine |
16-217 |
Complete |
RESNA ANSI |
WC-1:2019 Section 11 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins |
12/23/2019 |
Physical Medicine |
16-220 |
Complete |
RESNA ANSI |
WC-1:2019 Section 15 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling |
12/23/2019 |
Physical Medicine |
16-221 |
Complete |
RESNA ANSI |
WC-1:2019 Section 16 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods |
12/21/2020 |
Physical Medicine |
16-230 |
Complete |
RESNA ANSI |
WC-2:2019 Section 25 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs |
12/23/2019 |
Physical Medicine |
16-218 |
Complete |
RESNA ANSI |
WC-1:2019 Section 13 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of Coefficient of Friction of Test Surfaces |
12/23/2019 |
Physical Medicine |
16-227 |
Complete |
RESNA |
WC-4:2017 Section 18 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles. |
12/23/2019 |
Physical Medicine |
16-229 |
Complete |
RESNA ANSI |
WC-4:2017 Section 20 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles |
12/23/2019 |
Physical Medicine |
16-222 |
Complete |
RESNA ANSI |
WC-1:2019 Section 20 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs |
12/23/2019 |
Physical Medicine |
16-207 |
Complete |
RESNA ANSI |
WC-1:2019 Section 1 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability |
12/23/2019 |
Physical Medicine |
16-209 |
Complete |
RESNA ANSI |
WC-1:2019 Section 3 |
American National Standard for Wheelchairs - Volume 1: Additional Requirements for Wheelchairs (including Scooters) Section 3: Determination of effectiveness of brakes |
12/23/2019 |
Physical Medicine |
16-210 |
Complete |
RESNA ANSI |
WC-2:2019 Section 4 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range |
05/30/2022 |
Physical Medicine |
16-166 |
Partial |
ISO |
7176-21 Second edition 2009-04-01 |
Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
07/15/2019 |
Orthopedic |
11-350 |
Complete |
ASTM |
F2554-18 |
Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems |
12/21/2020 |
Orthopedic |
11-371 |
Complete |
ASTM |
F2009-20 |
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
12/21/2020 |
Orthopedic |
11-372 |
Complete |
ASTM |
F2996-20 |
Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
12/20/2021 |
Orthopedic |
11-392 |
Complete |
ASTM |
F2723-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation |
12/21/2020 |
Orthopedic |
11-375 |
Complete |
ASTM |
F2193-20 |
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
12/20/2021 |
Orthopedic |
11-389 |
Complete |
ISO |
7206-10 Second edition 2018-08 |
Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)] |
12/20/2021 |
Orthopedic |
11-388 |
Complete |
ASTM |
F1717-21 |
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
12/19/2022 |
Orthopedic |
11-397 |
Complete |
ASTM |
F3210-22e1 |
Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions |
12/19/2022 |
Orthopedic |
11-398 |
Complete |
ASTM |
F3574-22 |
Standard Test Methods for Sacroiliac Joint Fusion Devices |
12/20/2021 |
Orthopedic |
11-391 |
Complete |
ASTM |
F2722-21 |
Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops |
04/04/2016 |
Orthopedic |
11-303 |
Complete |
ASTM |
F3047M-15 |
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations |
01/30/2014 |
Orthopedic |
11-274 |
Complete |
ISO |
18192-2 First edition 2010-06-15 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements |
12/19/2022 |
Orthopedic |
11-394 |
Complete |
ASTM |
F1820-22 |
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
12/23/2016 |
Orthopedic |
11-311 |
Complete |
ISO |
14243-2 Third edition 2016-09-01 |
Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement |
12/18/2023 |
Orthopedic |
11-409 |
Complete |
ASTM |
F3495-23 |
Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components |
12/19/2022 |
Orthopedic |
11-395 |
Complete |
ASTM |
F1814-22 |
Standard Guide for Evaluating Modular Hip and Knee Joint Components |
12/19/2022 |
Orthopedic |
11-396 |
Complete |
ISO |
7206-13 First edition 2016-07-01 [Including AMD1:2022] |
Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)] |
07/06/2020 |
Orthopedic |
11-366 |
Complete |
ASTM |
F2381-19 |
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
07/15/2019 |
Orthopedic |
11-357 |
Complete |
ISO |
15142-3 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments |
12/18/2023 |
Orthopedic |
11-408 |
Complete |
ASTM |
F2777-23 |
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion |
01/30/2014 |
Orthopedic |
11-74 |
Complete |
ISO |
5838-2 First edition 1991-01-15 |
Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions |
01/30/2014 |
Orthopedic |
11-75 |
Complete |
ISO |
5838-3 First edition 1993-09-15 |
Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires |
09/17/2018 |
Orthopedic |
11-338 |
Complete |
ISO |
11491 First edition 2017-07 |
Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses |
12/20/2021 |
Orthopedic |
11-393 |
Complete |
ASTM |
F2724-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Dislocation |
12/20/2021 |
Orthopedic |
11-390 |
Complete |
ISO |
23089-2 First edition 2021-05 |
Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices |
12/20/2021 |
Orthopedic |
11-385 |
Complete |
ASTM |
F2345-21 |
Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
08/06/2013 |
Orthopedic |
11-254 |
Complete |
ISO |
14630 Fourth edition 2012-12-01 |
Non-active surgical implants -- General requirements |
07/15/2019 |
Orthopedic |
11-352 |
Complete |
ISO |
14242-1 Third edition 2014-10-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] |
06/27/2016 |
Orthopedic |
11-308 |
Complete |
ASTM |
F3161-16 |
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions |
01/30/2014 |
Orthopedic |
11-232 |
Complete |
ISO |
7207-1 Third edition 2007-02-01 |
Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions |
07/09/2014 |
Orthopedic |
11-277 |
Complete |
ISO |
7206-6 Second edition 2013-11-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components |
12/20/2021 |
Orthopedic |
11-386 |
Complete |
ASTM |
F2665-21 |
Standard Specification for Total Ankle Replacement Prosthesis |
08/14/2015 |
Orthopedic |
11-290 |
Complete |
ISO |
8828 Second edition 2014-11-15 |
Implants for surgery -- Guidance on care and handling of orthopaedic implants |
04/04/2016 |
Orthopedic |
11-301 |
Complete |
ASTM |
F2091-15 |
Standard Specification for Acetabular Prostheses |
09/17/2018 |
Orthopedic |
11-341 |
Complete |
ASTM |
F3140-17 |
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements |
09/11/2023 |
Orthopedic |
11-400 |
Complete |
ISO |
21536 Third edition 2023-07 |
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants |
09/17/2018 |
Orthopedic |
11-339 |
Complete |
ISO |
7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ] |
07/06/2020 |
Orthopedic |
11-365 |
Complete |
ASTM |
F1800-19 e1 |
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
09/17/2018 |
Orthopedic |
11-333 |
Complete |
ASTM |
F382-17 |
Standard Specification and Test Method for Metallic Bone Plates |
09/17/2018 |
Orthopedic |
11-340 |
Complete |
ASTM |
F3018-17 |
Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices |
06/07/2021 |
Orthopedic |
11-377 |
Complete |
ASTM |
F2083-21 |
Standard Specification for Knee Replacement Prosthesis |
01/27/2015 |
Orthopedic |
11-281 |
Complete |
ASTM |
F1672-14 (Reapproved 2019) |
Standard Specification for Resurfacing Patellar Prosthesis |
04/04/2016 |
Orthopedic |
11-299 |
Complete |
ASTM |
F2068-15 |
Standard Specification for Femoral Prostheses - Metallic Implants |
09/17/2018 |
Orthopedic |
11-337 |
Complete |
ISO |
16087 First edition 2013-10-01 |
Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants |
04/04/2016 |
Orthopedic |
11-247 |
Complete |
ASTM |
F2789-10 (Reapproved 2020) |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
12/20/2021 |
Orthopedic |
11-387 |
Complete |
ASTM |
F1781-21 |
Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
08/21/2017 |
Orthopedic |
11-269 |
Complete |
ASTM |
F2423-11 (Reapproved 2020) |
Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
01/27/2015 |
Orthopedic |
11-283 |
Complete |
ASTM |
F2943-14 (Reapproved 2019) |
Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty |
08/21/2017 |
Orthopedic |
11-175 |
Complete |
ASTM |
F1582-98 (Reapproved 2016) |
Standard Terminology Relating to Spinal Implants |
08/21/2017 |
Orthopedic |
11-309 |
Complete |
ASTM |
F116-12 (Reapproved 2016) |
Standard Specification for Medical Screwdriver Bits |
09/17/2018 |
Orthopedic |
11-334 |
Complete |
ASTM |
F1829-17 |
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
12/18/2023 |
Orthopedic |
11-407 |
Complete |
ASTM |
F3140-23 |
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements |
09/17/2018 |
Orthopedic |
11-335 |
Complete |
ASTM |
F3141-17a |
Standard Guide for Total Knee Replacement Loading Profiles |
08/21/2017 |
Orthopedic |
11-321 |
Complete |
ASTM |
F2887-17 |
Standard Specification for Total Elbow Prostheses |
12/18/2023 |
Orthopedic |
11-405 |
Complete |
ASTM |
F1829-23 |
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
09/17/2018 |
Orthopedic |
11-197 |
Complete |
ASTM |
F983-86 (Reapproved 2018) |
Standard Practice for Permanent Marking of Orthopaedic Implant Components |
09/17/2018 |
Orthopedic |
11-199 |
Complete |
ASTM |
F565-04 (Reapproved 2018) |
Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
09/17/2018 |
Orthopedic |
11-322 |
Complete |
ASTM |
F1541-17 |
Standard Specification and Test Methods for External Skeletal Fixation Devices |
09/17/2018 |
Orthopedic |
11-324 |
Complete |
ASTM |
F366-17 |
Standard Specification for Fixation Pins and Wires |
09/17/2018 |
Orthopedic |
11-325 |
Complete |
ASTM |
F564-17 |
Standard Specification and Test Methods for Metallic Bone Staples |
05/29/2023 |
Orthopedic |
11-399 |
Complete |
ASTM |
F1357-23 |
Standard Specification for Articulating Total Wrist Implants |
08/14/2015 |
Orthopedic |
11-294 |
Complete |
ASTM |
F1357-14 (Reapproved 2019) |
Standard Specification for Articulating Total Wrist Implants |
09/17/2018 |
Orthopedic |
11-326 |
Complete |
ASTM |
F384-17 |
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices |
09/17/2018 |
Orthopedic |
11-327 |
Complete |
ASTM |
F543-17 |
Standard Specification and Test Methods for Metallic Medical Bone Screws |
09/17/2018 |
Orthopedic |
11-329 |
Complete |
ASTM |
F2180-17 |
Standard Specification for Metallic Implantable Strands and Cables |