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Standards [CURRENT]

DIN EN 556-2

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015
Edition 2015-11

Draft standard

DIN EN 556-2

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023
Edition 2023-02

Standards [CURRENT]

DIN EN 15986

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
Edition 2011-05

Standards [CURRENT]

DIN EN ISO 17664-1

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021
Edition 2021-11

Standards [CURRENT]

DIN EN ISO 14971

Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
Edition 2022-04

Standards [CURRENT]

DIN 58953-8

Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
Edition 2019-03

Standards [CURRENT]

DIN EN 556-1 Berichtigung 1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1:2001/AC:2006
Edition 2006-12

Standards [CURRENT]

DIN EN ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022); German version EN ISO 10993-18:2020 + A1:2023
Edition 2023-11

Standards [CURRENT]

DIN EN ISO 20857

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013
Edition 2013-08

Standards [CURRENT]

DIN EN ISO 10993-17

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023); German version EN ISO 10993-17:2023
Edition 2024-02

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