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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

Draft standard

DIN EN ISO 14607

Non-active surgical implants - Mammary implants - Specific requirements (ISO/DIS 14607:2023); German and English version prEN ISO 14607:2023
Edition 2023-09

Standards [CURRENT]

DIN EN ISO 9712

Non-destructive testing - Qualification and certification of NDT personnel (ISO 9712:2021); German version EN ISO 9712:2022
Edition 2022-09

Standards [CURRENT]

DIN EN ISO 20417

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12); German version EN ISO 20417:2021
Edition 2022-03

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

Standards [New]

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

Standards [CURRENT]

DIN EN ISO 80601-2-84

Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO 80601-2-84:2023); German version EN ISO 80601-2-84:2023
Edition 2024-04

Standards [New]

DIN EN ISO 8637-2

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024); German version EN ISO 8637-2:2024
Edition 2024-09

Standards [CURRENT]

DIN EN ISO 11073-40101

Health informatics - Device interoperability - Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment (ISO/IEEE 11073-40101:2022); English version EN ISO/IEEE 11073-40101:2022
Edition 2022-07

Standards [CURRENT]

DIN EN ISO 15197

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015
Edition 2015-12

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