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Standards [CURRENT]

DIN EN ISO 10651-4

Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023); German version EN ISO 10651-4:2023
Edition 2023-10

Standards [CURRENT]

DIN EN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
Edition 2018-09

Standards [New]

DIN EN ISO 80601-2-55

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018 + Amd 1:2023); German version EN ISO 80601-2-55:2018 + A1:2023
Edition 2024-07

Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO/DIS 80601-2-79:2023); German and English version prEN ISO 80601-2-79:2023
Edition 2023-06

Standards [CURRENT]

DIN EN ISO 11073-40102

Health informatics - Device interoperability - Part 40102: Foundational - Cybersecurity - Capabilities for mitigation (ISO/IEEE 11073-40102:2022); English version EN ISO/IEEE 11073-40102:2022
Edition 2022-07

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

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 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 EN ISO/IEEE 11073-20601

Health informatics - Device interoperability - Part 20601: Personal health device communication - Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2022); English version EN ISO/IEEE 11073-20601:2022
Edition 2023-04

Standards [CURRENT]

BS EN ISO 17510

Medical devices. Sleep apnoea breathing therapy. Masks and application accessories
Edition 2020-02-19

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