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U.S. Department of Health and Human Services

Recognized Consensus Standards

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05/21/2018 Sterility 14-377 ASTM F2638-12 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
12/04/2017 Radiology 12-307 AAMI RT2:2017 Radiation therapy readiness check
12/04/2017 Software/
Informatics
13-98 IEC ISO 646 Third edition 1991-12-15 Information technology - IS0 7-bit coded character set for information interchange
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
13-100 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
13-101 IEC ISO 15459-6 Second ed. 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
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
13-103 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
08/21/2017 Anesthesiology 1-121 ISO 5359 Fourth edition 2014-10-01 Anaesthetic and respiratory equipment-Low-pressure hose assemblies for use with medical gases
08/21/2017 Anesthesiology 1-122 ISO 5364 Fifth edition 2016-09-01 Anaesthetic and respiratory equipment-Oropharyngeal airways
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