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Standards [CURRENT]

DIN EN ISO 17665-1

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006
Edition 2006-11

Standards [CURRENT]

DIN EN ISO 11615

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017 + Amd 1:2022); German version EN ISO 11615:2017 + A1:2022
Edition 2022-12

Standards [CURRENT]

DIN EN ISO 10993-12

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021
Edition 2021-08

Standards [CURRENT]

DIN EN ISO 14937

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009
Edition 2010-03

Standards [CURRENT]

DIN EN ISO 22367

Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020); German version EN ISO 22367:2020
Edition 2020-09

Standards [New]

DIN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024); German version EN ISO 12417-1:2024
Edition 2024-08

Draft standard

DIN EN ISO 22523

External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2022); German and English version prEN ISO 22523:2022
Edition 2022-05

Standards [CURRENT]

DIN EN ISO 11608-1

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022); German version EN ISO 11608-1:2022
Edition 2022-09

Standards [CURRENT]

DIN EN ISO 15883-4

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018); German version EN ISO 15883-4:2018
Edition 2019-06

Standards [available pre-publication]

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

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