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ISO 22442-1
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
Edition
2020-09
ISO 10993-15
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
Edition
2019-11
NF S98-117-7 ; NF EN ISO 13408-7:2015-11-14
Aseptic processing of health care products - Part 7: alternative processes for medical devices and combination products
Edition
2015-11-14
NF C74-801-1 ; NF EN IEC 80001-1:2021-10-29
Application of risk management for IT-networks incorporating medical devices - Part 1: safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Edition
2021-10-29
ISO 22441
Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition
2022-08
IEC/TR 62366-2
Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
Edition
2016-04
BS DD ISO/TS 10993-20
Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
Edition
2006-09-29
IEC 80001-1
Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management
Edition
2021-09
ISO/IEC Guide 63
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Edition
2019-08
ISO/TR 20416
Medical devices - Post-market surveillance for manufacturers
Edition
2020-07