|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
06/07/2021 |
Tissue Engineering |
15-67 |
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 |
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 |
ASTM |
F2260-18 |
Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy |
09/17/2018 |
Tissue Engineering |
15-55 |
ASTM |
F3259-17 |
Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds |
06/07/2018 |
Tissue Engineering |
15-53 |
ASTM |
F3206-17 |
Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies |
01/14/2019 |
Tissue Engineering |
15-47 |
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. |
01/14/2019 |
Tissue Engineering |
15-56 |
ASTM |
F3224-17 |
Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging |
08/06/2013 |
Tissue Engineering |
15-14 |
ASTM |
F2603-06 (Reapproved 2020) |
Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds |
07/09/2014 |
Tissue Engineering |
15-40 |
ASTM |
F2211-13 |
Standard Classification for Tissue Engineered Medical Products (TEMPs) |
07/06/2020 |
Tissue Engineering |
15-63 |
ASTM |
F2739-19 |
Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds |
06/07/2018 |
Tissue Engineering |
15-54 |
ASTM |
F3207-17 |
Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model |
07/06/2020 |
Tissue Engineering |
15-61 |
ASTM |
F2150-19 |
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products |
07/15/2019 |
Tissue Engineering |
15-57 |
ASTM |
F2315-18 |
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
12/23/2016 |
Tissue Engineering |
15-48 |
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) |
03/16/2012 |
Tissue Engineering |
15-31 |
ASTM |
F2312-11 (Reapproved 2020) |
Standard Terminology Relating to Tissue Engineered Medical Products |
04/04/2016 |
Tissue Engineering |
15-43 |
ASTM |
F2791-15 |
Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
04/04/2016 |
Tissue Engineering |
15-24 |
ASTM |
F2721-09 (Reapproved 2014) |
Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects |
06/07/2018 |
Tissue Engineering |
15-51 |
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 |
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 |
07/06/2020 |
Tissue Engineering |
15-59 |
ASTM |
F2450-18 |
Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products |
07/06/2020 |
Tissue Engineering |
15-62 |
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) |
08/21/2017 |
Tissue Engineering |
15-49 |
ASTM |
F2027-16 |
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
07/15/2019 |
Tissue Engineering |
15-58 |
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 |
12/21/2020 |
Tissue Engineering |
15-64 |
ISO |
22442-1 Third edition 2020-09 |
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
04/04/2016 |
Tissue Engineering |
15-44 |
ASTM |
F2529-13 |
Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) |
01/14/2019 |
Sterility |
14-396 |
ANSI AAMI |
ST77:2013/(R)2018 |
Containment devices for reusable medical device sterilization |
08/14/2015 |
Sterility |
14-460 |
ANSI AAMI ISO |
11140-1:2014 |
Sterilization of health care products - Chemical indicators - Part 1: General requirements |
ISO |
11140-1 Third edition 2014-11-01 |
Sterilization of health care products - Chemical indicators - Part 1: General requirements |
05/30/2022 |
Sterility |
14-572 |
ANSI AAMI |
ST91:2021 |
Flexible and semi-rigid endoscope processing in health care facilities |
01/30/2014 |
Sterility |
14-334 |
ANSI AAMI ISO |
15882:2008/(R)2013 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results |
ISO |
15882 Second edition 2008-09-01 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results |
01/30/2014 |
Sterility |
14-336 |
ANSI AAMI ISO |
14161-2009/(R)2014 |
Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results |
ISO |
14161 Second edition 2009-09-15 |
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results |
07/06/2020 |
Sterility |
14-515 |
ANSI AAMI ISO |
17664:2017 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices |
ISO |
17664 Second edition 2017-10 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices |
05/30/2022 |
Sterility |
14-578 |
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 |
12/20/2021 |
Sterility |
14-571 |
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 |
12/23/2016 |
Sterility |
14-497 |
ASTM |
F1980-16 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
05/30/2022 |
Sterility |
14-576 |
ASTM |
D4169-22 |
Standard Practice for Performance Testing of Shipping Containers and Systems |
12/23/2016 |
Sterility |
14-499 |
ASTM |
D4169-16 |
Standard Practice for Performance Testing of Shipping Containers and Systems |
01/30/2014 |
Sterility |
14-401 |
ASTM |
F2217/F2217M-13 (Reapproved 2018) |
Standard Practice for Coating/Adhesive Weight Determination |
12/21/2020 |
Sterility |
14-553 |
ASTM |
F2097-20 |
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
12/20/2021 |
Sterility |
14-563 |
ISO |
13408-6 Second edition 2021-04 |
Aseptic processing of health care products - Part 6: Isolator systems |
12/20/2021 |
Sterility |
14-567 |
USP-NF |
M7414_01_01 |
<1229.5> Biological Indicators for Sterilization |
12/20/2021 |
Sterility |
14-568 |
USP-NF |
M98800_01_01 |
<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests |
12/20/2021 |
Sterility |
14-569 |
USP-NF |
M98810_01_01 |
<71> Sterility Tests |
12/20/2021 |
Sterility |
14-570 |
USP-NF |
M98830_02_01 |
<85> Bacterial Endotoxins Test |
12/20/2021 |
Sterility |
14-566 |
USP-NF |
M98795_02_01 |
<55> Biological Indicators -- Resistance Performance Tests |
12/19/2022 |
Sterility |
14-583 |
ANSI AAMI |
ST98:2022 |
Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices |
05/30/2022 |
Sterility |
14-579 |
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. |
12/19/2022 |
Sterility |
14-580 |
ANSI AAMI ISO |
11137-2:2013 |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose |
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)] |
04/04/2016 |
Sterility |
14-409 |
ANSI AAMI ISO |
|
Standard |
ISO |
11137-2 Third edition 2013-06-01 |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose |
09/17/2018 |
Sterility |
14-514 |
ANSI AAMI ISO |
11737-1:2018 |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microrganisms on products |
ISO |
11737-1 Third edition 2018-01 |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product |
09/09/2008 |
Sterility |
14-191 |
ANSI AAMI ISO |
13408-4:2005/(R)2014 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
ISO |
13408-4 First edition 2005-11-01 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
06/27/2016 |
Sterility |
14-481 |
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 |
01/27/2015 |
Sterility |
14-166 |
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 |
14-517 |
ASTM |
F3293-18 |
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
12/20/2021 |
Sterility |
14-564 |
USP-NF |
M98910_01_01 |
<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests |
12/20/2021 |
Sterility |
14-565 |
USP-NF |
M98802_01_01 |
<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms |
04/04/2016 |
Sterility |
14-333 |
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 |
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 |
08/21/2017 |
Sterility |
14-501 |
ASTM |
F1886/F1886M-16 |
Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection |
08/21/2017 |
Sterility |
14-502 |
ANSI AAMI ISO |
11138-1:2017 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
ISO |
11138-1 Third edition 2017-03 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
07/06/2020 |
Sterility |
14-539 |
ASTM |
F2475-20 |
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
04/04/2016 |
Sterility |
14-337 |
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 |
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 |
01/15/2013 |
Sterility |
14-359 |
ASTM |
F2096-11 (Reapproved 2019) |
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) |
12/19/2022 |
Sterility |
14-582 |
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 |
05/30/2022 |
Sterility |
14-577 |
ANSI AAMI ISO |
11737-1:2018 |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microrganisms on products |
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)] |
01/15/2013 |
Sterility |
14-213 |
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 |
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 |
AOAC |
6.3.02:2006 |
Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes |
01/27/2015 |
Sterility |
14-242 |
ISO |
14644-3 First edition 2005-12-15 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
01/30/2014 |
Sterility |
14-404 |
ASTM |
F2250-13 (Reapproved 2018) |
Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials |
01/30/2014 |
Sterility |
14-405 |
ASTM |
F2252/F2252M-13 (Reapproved 2018) |
Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape |
01/30/2014 |
Sterility |
14-406 |
ANSI AAMI |
ST8:2013/(R)2018 |
Hospital steam sterilizers |
08/06/2013 |
Sterility |
14-381 |
ASTM ISO |
51261 Second edition 2013-04-15 |
Practice for calibration of routine dosimetry systems for radiation processing |
12/21/2020 |
Sterility |
14-551 |
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 |
07/15/2019 |
Sterility |
14-529 |
ANSI AAMI ISO |
11135:2014 |
Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. |
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)] |
07/15/2019 |
Sterility |
14-530 |
ANSI AAMI ISO |
11607-1:2019 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
ISO |
11607-1 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
03/16/2012 |
Sterility |
14-332 |
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 |
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 |
09/09/2008 |
Sterility |
14-240 |
ANSI AAMI ISO |
13408-5:2006/(R)2015 |
Aseptic processing of health care products - Part 5: Sterilization in place |
ISO |
13408-5 First edition 2006-11-15 |
Aseptic processing of health care products - Part 5: Sterilization-in-place |
04/04/2016 |
Sterility |
14-277 |
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 |
ANSI AAMI ISO |
13408-7:2012 |
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products |
ISO |
13408-7 First edition 2012-08-01 |
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products |
01/27/2015 |
Sterility |
14-389 |
ISO |
14644-9 First edition 2012-08-15 |
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration |
01/27/2015 |
Sterility |
14-390 |
ISO |
14644-10 First edition 2013-03-01 |
Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration |
01/30/2014 |
Sterility |
14-398 |
AOAC |
6.3.05:2013 |
Official Method 966.04, Sporicidal Activity of Disinfectants Method I |
01/30/2014 |
Sterility |
14-399 |
AOAC |
6.3.06:2012 |
Official Method 965.12 Tuberculocidal Activity of Disinfectants |
01/30/2014 |
Sterility |
14-400 |
ASTM |
F2203-13 (Reapproved 2018) |
Standard Test Method for Linear Measurement Using Precision Steel Rule |
01/30/2014 |
Sterility |
14-412 |
AOAC |
6.2.01:2013 |
Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method |
06/27/2016 |
Sterility |
14-483 |
ASTM ISO |
52303 First edition 2015-07-15 |
Guide for absorbed-dose mapping in radiation processing facilities |
01/30/2014 |
Sterility |
14-395 |
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)] |
01/30/2014 |
Sterility |
14-397 |
AOAC |
6.2.04:2013 |
Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method |
09/17/2018 |
Sterility |
14-512 |
ANSI AAMI ISO |
13408-2:2018 |
Aseptic processing of health care products - Part 2:Sterilizing filtration |
ISO |
13408-2 Second edition 2018-01 |
Aseptic processing of health care products - Part 2: Sterilizing filtration. |
09/17/2018 |
Sterility |
14-275 |
ANSI AAMI |
ST41:2008/(R)2018 |
Ethylene oxide sterilization in health care facilities: Safety and effectiveness |
07/09/2014 |
Sterility |
14-286 |
ANSI AAMI |
ST65:2008/(R)2018 |
Processing of reusable surgical textiles for use in health care facilities |
01/30/2014 |
Sterility |
14-430 |
ASTM ISO |
51607 Third edition 2013-06-01 |
Practice for use of an alanine-EPR dosimery system |
01/27/2015 |
Sterility |
14-456 |
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 |
01/14/2019 |
Sterility |
14-518 |
ANSI AAMI |
ST55:2016 |
Table-top steam sterilizers |
09/17/2018 |
Sterility |
14-294 |
ANSI AAMI |
ST40:2004/(R)2018 |
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities |
09/17/2018 |
Sterility |
14-513 |
ASTM |
F2825-18 |
Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery |
09/17/2018 |
Sterility |
14-516 |
ASTM |
F3039-15 |
Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
12/23/2016 |
Sterility |
14-169 |
ASTM |
F2391-05 (Reapproved 2016) |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
07/09/2014 |
Sterility |
14-282 |
ASTM |
F2338-09 (Reapproved 2020) |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method |
01/30/2014 |
Sterility |
14-403 |
ASTM |
F2054/F2054M-13 (Reapproved 2020) |
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates |
09/09/2008 |
Sterility |
14-142 |
ISO |
14698-1:2003 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods |