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Guidline

Pre-standard

ISO/TS 21726

Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Edition 2019-02

Technical rule [CURRENT]

ISO/TR 21730

Health informatics - Use of mobile wireless communication and computing technology in healthcare facilities - Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
Edition 2007-02

Pre-standard

ISO/TS 22421

Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Edition 2021-01

Standards [CURRENT]

ISO 22442-1

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
Edition 2020-09

Standards [CURRENT]

ISO 22442-2

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
Edition 2020-09

Standards [CURRENT]

ISO 22442-3

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
Edition 2007-12

Technical rule [CURRENT]

ISO/TR 22442-4

Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
Edition 2010-12

Pre-standard

ISO/TS 22456

Sterilization of healthcare products - Microbiological methods - Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
Edition 2021-03

Technical rule [CURRENT]

ISO/TR 37137

Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
Edition 2014-05

Pre-standard

ISO/TS 37137-1

Biological evaluation of absorbable medical devices - Part 1: General requirements
Edition 2021-03

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