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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 10993-15

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
Edition 2019-11

Aseptic processing of health care products - Part 7: alternative processes for medical devices and combination products
Edition 2015-11-14

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

Standards [CURRENT]

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

Technical rule [CURRENT]

IEC/TR 62366-2

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
Edition 2016-04

Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
Edition 2006-09-29

Standards [CURRENT]

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

Technical rule [CURRENT]

ISO/IEC Guide 63

Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Edition 2019-08

Technical rule [CURRENT]

ISO/TR 20416

Medical devices - Post-market surveillance for manufacturers
Edition 2020-07

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