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Standards [CURRENT]

DIN EN ISO 8637-1

Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017); German version EN ISO 8637-1:2020
Edition 2020-10

Standards [CURRENT]

DIN EN ISO 11608-7

Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016); German version EN ISO 11608-7:2017
Edition 2017-10

Standards [CURRENT]

DIN EN 1717

Protection against pollution of potable water installations and general requirements of devices to prevent pollution by backflow; German version EN 1717:2000; Technical rule of the DVGW
Edition 2011-08

Standards [CURRENT]

DIN EN ISO 13408-3

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006); German version EN ISO 13408-3:2011
Edition 2011-09

Standards [Pre-order]

DIN EN ISO 17665

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024); German version EN ISO 17665:2024
Edition 2024-09

Standards [CURRENT]

DIN EN ISO 7864

Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016); German version EN ISO 7864:2016
Edition 2016-12

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

Draft standard

DIN EN ISO 17665

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022
Edition 2022-11

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024); German and English version EN ISO 10993-4:2017/prA1:2024
Edition 2024-04

Standards [CURRENT]

DIN EN ISO 9999

Assistive products - Classification and terminology (ISO 9999:2022); German version EN ISO 9999:2022
Edition 2022-10

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