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Draft standard [New]

DIN EN 455-5

Medical gloves for single use - Part 5: Extractable chemical residues; German and English version prEN 455-5:2024
Edition 2024-08

Draft standard

DIN ISO 31030

Travel risk management - Guidance for organizations (ISO 31030:2021); Text in German and English
Edition 2023-07

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

Standards [CURRENT]

DIN EN ISO 15378

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017
Edition 2018-04

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 [CURRENT]

DIN EN ISO 80601-2-80

Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018); German version EN ISO 80601-2-80:2019
Edition 2020-02

Standards [CURRENT]

DIN EN ISO 80601-2-79

Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018); German version EN ISO 80601-2-79:2019
Edition 2020-02

Standards [CURRENT]

DIN EN ISO 10993-17

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023); German version EN ISO 10993-17:2023
Edition 2024-02

Standards [CURRENT]

DIN EN 15004-1

Fixed firefighting systems - Gas extinguishing systems - Part 1: Design, installation and maintenance (ISO 14520-1:2015, modified); German version EN 15004-1:2019
Edition 2019-06

Standards [CURRENT]

DIN EN ISO 10993-4

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
Edition 2017-12

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