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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 13485

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
Edition 2021-12

Standards [CURRENT]

DIN EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
Edition 2021-05

Standards [CURRENT]

DIN EN ISO 80601-2-74

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021); German version EN ISO 80601-2-74:2021
Edition 2022-01

Standards [CURRENT]

DIN EN ISO 23500-1

Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019); German version EN ISO 23500-1:2019
Edition 2019-11

Standards [CURRENT]

DIN EN ISO 9241-307

Ergonomics of human-system interaction - Part 307: Analysis and compliance test methods for electronic visual displays (ISO 9241-307:2008); German version EN ISO 9241-307:2008
Edition 2009-06

Standards [CURRENT]

DIN EN ISO 25539-1

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017); German version EN ISO 25539-1:2017
Edition 2018-05

Standards [CURRENT]

DIN EN ISO/IEC 18045

Information technology - Security techniques - Methodology for IT security evaluation (ISO/IEC 18045:2008); German version EN ISO/IEC 18045:2020, only on CD-ROM
Edition 2021-02

Draft standard [New]

DIN EN ISO/IEC 27701

Information security, cybersecurity and privacy protection - Privacy information management systems - Requirements and guidance (ISO/IEC DIS 27701:2024); German and English version prEN ISO/IEC 27701:2024
Edition 2024-09

Standards [CURRENT]

DIN EN ISO 9001

Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015
Edition 2015-11

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