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Standards [CURRENT]

DIN EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
Edition 2017-09

Standards [CURRENT]

DIN EN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
Edition 2018-09

Standards [CURRENT]

DIN EN ISO 15223-1

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021); German version EN ISO 15223-1:2021, with CD-ROM
Edition 2022-02

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 10993-9

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019); German version EN ISO 10993-9:2021
Edition 2022-03

Standards [CURRENT]

DIN EN 1097-2

Tests for mechanical and physical properties of aggregates - Part 2: Methods for the determination of resistance to fragmentation; German version EN 1097-2:2020
Edition 2020-06

Standards [CURRENT]

DIN EN ISO 11135

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019
Edition 2020-04

Draft standard

DIN EN ISO 23908

Sharps injury protection - Requirements and test methods - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration (ISO/DIS 23908:2023); German and English version prEN ISO 23908:2023
Edition 2023-11

Draft standard

DIN EN 18029

Animal health diagnostic analyses - Electronic data exchange in laboratory analysis; German and English version prEN 18029:2023
Edition 2023-11

Standards [CURRENT]

DIN EN ISO 25424

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018 + Amd 1:2022); German version EN ISO 25424:2019 + A1:2022
Edition 2022-07

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