Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management system.

Biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process
Edition 2020-12-16

Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
Edition 2021-12

Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
Edition 2016-02

Biological evaluation of medical devices. Toxicological risk assessment of medical device constituents
Edition 2023-11-23

Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
Edition 2022-05-19

Medical devices. Symbols to be used with information to be supplied by the manufacturer. General requirements
Edition 2021-09-29

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition 2014-07-16

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - AMENDMENT 1: Revision of Annex E, Single batch release
Edition 2019-11-20

Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
Edition 2011-04