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PR NF S99-501-1 ; PR NF EN ISO 10993-1
Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management system.
NF S99-501-1 ; NF EN ISO 10993-1:2020-12-16
Biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process
Edition
2020-12-16
IEC 81001-5-1
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
Edition
2021-12
ISO 15883-7
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
BS EN ISO 10993-17
Biological evaluation of medical devices. Toxicological risk assessment of medical device constituents
Edition
2023-11-23
BS EN ISO 10993-9
Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products
Edition
2022-05-19
BS EN ISO 15223-1
Medical devices. Symbols to be used with information to be supplied by the manufacturer. General requirements
Edition
2021-09-29
NF S98-101 ; NF EN ISO 11135:2014-07-16
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition
2014-07-16
NF S98-101/A1 ; NF EN ISO 11135/A1:2019-11-20
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
ISO 15883-6
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