|
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)
|
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 |
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 |
12/23/2016 |
Sterility |
14-497 |
Complete |
ASTM |
F1980-16 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
06/27/2015 |
Sterility |
14-484 |
Complete |
ASTM |
F1929-15 |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
06/27/2016 |
Sterility |
14-483 |
Complete |
ISO ASTM |
52303 First edition 2015-07-15 |
Guide for absorbed-dose mapping in radiation processing facilities |
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 |
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 |
14-464 |
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 |
14-463 |
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 |
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 |
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 |
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 |
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 |
14-434 |
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 |
14-433 |
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 |
07/09/2014 |
Sterility |
14-432 |
Complete |
ANSI AAMI |
ST58:2013/(R)2018 |
Chemical sterilization and high-level disinfection in health care facilities |
01/30/2014 |
Sterility |
14-430 |
Complete |
ISO ASTM |
51607 Third edition 2013-06-01 |
Practice for use of an alanine-EPR dosimery system |
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)] |
01/30/2014 |
Sterility |
14-413 |
Complete |
AOAC |
6.2.06:2013 |
Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method |
01/30/2014 |
Sterility |
14-412 |
Complete |
AOAC |
6.2.01:2013 |
Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method |
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 |
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 |
01/30/2014 |
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 |
14-402 |
Complete |
ASTM |
F1140/F1140M-13 (Reapproved 2020)e1 |
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages |
01/30/2014 |
Sterility |
14-401 |
Complete |
ASTM |
F2217/F2217M-13 (Reapproved 2023) |
Standard Practice for Coating/Adhesive Weight Determination |
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 |
14-399 |
Complete |
AOAC |
6.3.06:2012 |
Official Method 965.12 Tuberculocidal Activity of Disinfectants |
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 |
14-397 |
Complete |
AOAC |
6.2.04:2013 |
Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method |
01/14/2019 |
Sterility |
14-396 |
Partial |
ANSI AAMI |
ST77:2013/(R)2018 |
Containment devices for reusable medical device sterilization |
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)] |
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 |
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 |
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 |
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 |
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) |
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) |
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 |
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 |
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 |
14-334 |
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 |
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 |
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 |
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 |
09/17/2018 |
Sterility |
14-293 |
Complete |
ANSI AAMI |
ST50:2004/(R)2018 |
Dry heat (heated air) sterilizers |
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. |
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 |
14-282 |
Complete |
ASTM |
F2338-09 (Reapproved 2020) |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method |
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 |
09/17/2018 |
Sterility |
14-275 |
Complete |
ANSI AAMI |
ST41:2008/(R)2018 |
Ethylene oxide sterilization in health care facilities: Safety and effectiveness |
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 |
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 |
01/27/2015 |
Sterility |
14-243 |
Complete |
ISO |
14644-6 First edition 2007-07-15 |
Cleanrooms and associated controlled environments - Part 6: Vocabulary |
01/27/2015 |
Sterility |
14-242 |
Complete |
ISO |
14644-3 First edition 2005-12-15 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
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 |
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 |
01/15/2013 |
Sterility |
14-217 |
Complete |
AOAC |
6.3.02:2006 |
Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes |
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 |
14-213 |
Complete |
AOAC |
6.2.03:2006 |
Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method |
01/15/2013 |
Sterility |
14-212 |
Complete |
AOAC |
6.2.02:2006 |
Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method |
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 |
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 |
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) |
01/27/2015 |
Sterility |
14-165 |
Complete |
ISO |
14644-5 First edition 2004-08-15 |
Cleanrooms and associated controlled environments - Part 5: Operations |
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 |
10/09/2023 |
Software/ Informatics |
13-131 |
Complete |
ANSI AAMI |
SW96:2023 |
Standard for medical device security - Security risk management for device manufacturers |
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 |
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 |
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 |
12/19/2022 |
Software/ Informatics |
13-127 |
Complete |
ANSI AAMI UL |
2800-1-3:2022 |
Standard for Interoperable Item Integration Life Cycle |
12/19/2022 |
Software/ Informatics |
13-126 |
Complete |
ANSI AAMI UL |
2800-1-2:2022 |
Standard for Interoperable Item Development Life Cycle |
12/19/2022 |
Software/ Informatics |
13-125 |
Complete |
ANSI AAMI UL |
2800-1-1:2022 |
Standard for Risk Concerns for Interoperable Medical Products |
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 |
13-123 |
Complete |
ANSI NEMA |
HN 1-2019 |
American National Standard Manufacturer Disclosure Statement for Medical Device Security |
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
|
12/19/2022 |
Software/ Informatics |
13-121 |
Complete |
ANSI AAMI UL |
2800-1:2022 |
Standard for Medical Device Interoperability |
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 |
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. |
06/07/2021 |
Software/ Informatics |
13-118 |
Complete |
IEEE |
Std 11073-40102:2020 |
Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation. |
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. |
10/19/2020 |
Software/ Informatics |
13-116 |
Complete |
FIRST |
CVSS v3.0 |
Common Vulnerability Scoring System version 3.0 |
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 |
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 |
13-113 |
Complete |
IEEE |
Std 11073-20601-2019 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol. |
12/23/2019 |
Software/ Informatics |
13-112 |
Complete |
AAMI |
TIR97:2019 |
Principles for medical device security - Postmarket risk management for device manufacturers |
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 |
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 |
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 |
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 |
01/14/2019 |
Software/ Informatics |
13-105 |
Complete |
ANSI AAMI |
SW91:2018 |
Classification of defects in health software |
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 |
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 |
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 |
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 |
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 |