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Standards [CURRENT]

DIN EN ISO 22442-1

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020
Edition 2021-08

Draft standard

DIN EN ISO 18562-1

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO/DIS 18562-1:2022); German and English version prEN ISO 18562-1:2022
Edition 2022-12

Draft standard

DIN EN ISO 80369-2

Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO/DIS 80369-2:2021); German and English version prEN ISO 80369-2:2021
Edition 2021-06

Draft standard [New]

DIN EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024
Edition 2024-07

Standards [CURRENT]

DIN EN ISO 11073-00103

Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015); English version EN ISO 11073-00103:2017
Edition 2017-05

Standards [CURRENT]

DIN ISO 13022

Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
Edition 2014-06

Standards [CURRENT]

DIN EN ISO 11607-1

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023); German version EN ISO 11607-1:2020 + A1:2023
Edition 2024-02

Standards [CURRENT]

DIN EN ISO 11607-2

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019 + Amd 1:2023); German version EN ISO 11607-2:2020 + A1:2023
Edition 2024-02

Standards [CURRENT]

DIN EN 17124

Hydrogen fuel - Product specification and quality assurance for hydrogen refuelling points dispensing gaseous hydrogen - Proton exchange membrane (PEM) fuel cell applications for vehicles; German version EN 17124:2022
Edition 2022-12

Standards [CURRENT]

DIN ISO 24516-4

Guidelines for the management of assets of water supply and wastewater systems - Part 4: Wastewater treatment plants, sludge treatment facilities, pumping stations, retention and detention facilities (ISO 24516-4:2019)
Edition 2021-08

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