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Draft standard

DIN EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024
Edition 2024-06

Standards [CURRENT]

DIN EN ISO 80601-2-85

Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021); German version EN ISO 80601-2-85:2021
Edition 2022-01

Standards [New]

DIN EN ISO 23500-3

Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024); German version EN ISO 23500-3:2024
Edition 2024-09

Standards [CURRENT]

DIN EN ISO 80601-2-61

Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02); German version EN ISO 80601-2-61:2019
Edition 2019-09

Draft standard [Pre-order]

DIN EN ISO 80601-2-61

Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO/DIS 80601-2-61:2024); German and English version prEN ISO 80601-2-61:2024
Edition 2025-01

Standards [CURRENT]

DIN EN ISO 11073-10101

Health informatics - Device interoperability - Part 10101: Point-of-care medical device communication - Nomenclature (ISO/IEEE 11073-10101:2020); English version EN ISO 11073-10101:2020, only on CD-ROM
Edition 2021-01

Empfehlungen für Betreiber, Behörden und Veranstalter
Edition 2023-05

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