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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
ISO/TS 10993-19
Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
Edition
2020-03
ISO/TR 80001-2-6
Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
Edition
2014-12
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
2014/13/EU
Commission Delegated Directive 2014/13/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators
Edition
2013-10-18
BS EN ISO 10993-14
Biological evaluation of medical devices. Identification and quantification of degradation products from ceramics
Edition
2009-06-30
ISO/TS 16775
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
Edition
2021-11
ISO/TR 37137
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
Edition
2014-05
ISO/TS 23128
Medical devices - Transfusion set and blood bag compatibility test method
Edition
2019-12
PD ISO/TR 22442-4
Medical devices utilizing animal tissues and their derivatives. Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
Edition
2011-02-28
