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U.S. Department of Health and Human Services

Recognized Consensus Standards

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08/14/2015 Sterility 14-463 ASTM ISO 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 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
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
07/09/2014 Sterility 14-437 ASTM ISO 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 ASTM F2251-13 (Reapproved 2018) Standard Test Method for Thickness Measurement of Flexible Packaging Material
07/09/2014 Sterility 14-434 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 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 ANSI AAMI ST58:2013/(R)2018 Chemical sterilization and high-level disinfection 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
01/30/2014 Sterility 14-429 ASTM ISO 51275 Third edition 2013-06-01 Practice for use of a radiochromic film dosimetry system
01/30/2014 Sterility 14-427 ANSI AAMI ISO 13408-1:2008 (R2011) Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
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 14-424 ANSI AAMI ISO 13408-6:2005/(R) 2013 & A1:2013 Aseptic processing of health care products - Part 6: Isolator systems [Including AMENDMENT1 (2013)]
ISO 13408-6 First edition 2005-06-15 Aseptic processing of health care products - Part 6: Isolator systems [Including: Amendment 1 (2013)]
01/30/2014 Sterility 14-413 AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
01/30/2014 Sterility 14-412 AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
04/04/2016 Sterility 14-409 ANSI AAMI ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-2 Third edition 2013-06-01 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
01/30/2014 Sterility 14-406 ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
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 14-404 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 14-403 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 ASTM F1140/F1140M-13 (Reapproved 2020)e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
01/30/2014 Sterility 14-401 ASTM F2217/F2217M-13 (Reapproved 2018) Standard Practice for Coating/Adhesive Weight Determination
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 14-399 AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of Disinfectants
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 14-397 AOAC 6.2.04:2013 Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
01/14/2019 Sterility 14-396 ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
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)]
01/27/2015 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
01/27/2015 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
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
08/06/2013 Sterility 14-383 ASTM ISO 51702 Third edition 2013-04-15 Practice for dosimetry in a gamma facility for radiation processing
08/06/2013 Sterility 14-381 ASTM ISO 51261 Second edition 2013-04-15 Practice for calibration of routine dosimetry systems for radiation processing
01/27/2015 Sterility 14-379 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 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 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
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
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
01/30/2014 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
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
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
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
09/17/2018 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 14-293 ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers
07/09/2014 Sterility 14-290 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 ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities
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
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
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 14-257 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 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 ISO 14644-6 First edition 2007-07-15 Cleanrooms and associated controlled environments - Part 6: Vocabulary
01/27/2015 Sterility 14-242 ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
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
09/09/2008 Sterility 14-239 ANSI AAMI ISO 13408-3:2006/(R)2015 Aseptic processing of health care products - Part 3: Lyophilization
ISO 13408-3 First edition 2006-09-15 Aseptic processing of health care products - Part 3: Lyophilization
01/15/2013 Sterility 14-217 AOAC 6.3.02:2006 Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
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 14-213 AOAC 6.2.03:2006 Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
01/15/2013 Sterility 14-212 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 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
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
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)
01/27/2015 Sterility 14-165 ISO 14644-5 First edition 2004-08-15 Cleanrooms and associated controlled environments - Part 5: Operations
09/09/2008 Sterility 14-142 ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
01/27/2015 Sterility 14-141 ISO 14644-4 First edition 2001-04-01 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
12/20/2021 Software/
Informatics
13-120 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 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 IEEE Std 11073-40102:2020 Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation.
06/07/2021 Software/
Informatics
13-117 IEEE Std 11073-40101-2020 Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment.
10/19/2020 Software/
Informatics
13-116 FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0
07/06/2020 Software/
Informatics
13-115 IEC IEEE ISO 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 IEEE Std 11073-10101-2019 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
07/06/2020 Software/
Informatics
13-113 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 AAMI TIR97:2019 Principles for medical device security - Postmarket risk management for device manufacturers
12/23/2019 Software/
Informatics
13-111 IEEE Std 11073-10201-2018 Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model
07/15/2019 Software/
Informatics
13-109 AAMI ANSI UL 2800-1: 2019 Standard for Safety for Medical Device Interoperability
07/15/2019 Software/
Informatics
13-108 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 IEEE Std 11073-20702-2016 Health informatics - Point-of-care medical device communication Part 20702: Medical Devices
ISO 11073-20702 First edition 2018-09 Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
01/14/2019 Software/
Informatics
13-106 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 ANSI AAMI SW91:2018 Classification of defects in health software
06/07/2018 Software/
Informatics
13-104 ANSI UL 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 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 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 IEC ISO 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 IEC ISO 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 IEC ISO 15459-2 Third edition 2015-03-01 Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures
12/04/2017 Software/
Informatics
13-98 IEC INCITS ISO 646 Third edition 1991-12-15 (R2018) Information technology - IS0 7-bit coded character set for information interchange
INCITS ISO IEC 646:1991[R2018] Information technology - IS0 7-bit coded character set for information interchange
08/21/2017 Software/
Informatics
13-97 IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
08/21/2017 Software/
Informatics
13-96 ANSI UL 2900-1 First Edition 2017 Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements
08/21/2017 Software/
Informatics
13-95 IEEE ISO 11073-10425 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)
08/21/2017 Software/
Informatics
13-94 IEEE ISO 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)]
08/21/2017 Software/
Informatics
13-93 IEEE Std 11073-10422-2016 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
08/21/2017 Software/
Informatics
13-92 IEEE ISO 11073-10421 First edition 2012-11-01 Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
08/21/2017 Software/
Informatics
13-91 IEEE ISO 11073-10419 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
08/21/2017 Software/
Informatics
13-90 IEEE Std 11073-10417-2015 Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter
08/21/2017 Software/
Informatics
13-89 IEEE ISO 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)
08/21/2017 Software/
Informatics
13-88 IEEE ISO 11073-10417 Third edition 2017-04 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
12/23/2016 Software/
Informatics
13-87 IEC ISO 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
12/23/2016 Software/
Informatics
13-86 IEC ISO 15026-1 First edition 2013-11-01 Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
12/23/2016 Software/
Informatics
13-85 CLSI AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition
06/27/2016 Software/
Informatics
13-84 IEEE ISO 11073-10103 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
06/27/2016 Software/
Informatics
13-83 AAMI TIR57:2016 Principles for medical device security - Risk management.
 
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