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Standards [New]

DIN EN ISO 15189

Medical laboratories - Requirements for quality and competence (ISO 15189:2022); German version EN ISO 15189:2022 + A11:2023
Edition 2024-08

Standards [CURRENT]

DIN EN 15221-4

Facility Management - Part 4: Taxonomy, Classification and Structures in Facility Management; German version EN 15221-4:2011
Edition 2011-12

Standards [CURRENT]

DIN EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015
Edition 2015-12

Draft standard

DIN EN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021); German and English version prEN ISO 18113-1:2021
Edition 2021-09

Standards [CURRENT]

DIN EN ISO 80601-2-67

Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO 80601-2-67:2020); German version EN ISO 80601-2-67:2020
Edition 2021-06

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

Draft standard

DIN EN ISO 16571

Systems for evacuation of plume generated by medical devices (ISO/DIS 16571:2023); German and English version prEN ISO 16571:2023
Edition 2023-03

Draft standard [New]

DIN EN ISO/IEEE 11073-10701

Health informatics - Device interoperability - Part 10701: Point-of-Care Medical Device Communication - Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System (ISO/IEEE FDIS 11073-10701:2024); English version prEN ISO IEEE 11073-10701:2024
Edition 2024-07

Standards [New]

DIN EN ISO 20916

In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German version EN ISO 20916:2024
Edition 2024-07

Standards [CURRENT]

DIN EN ISO 80601-2-87

Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87:2021); German version EN ISO 80601-2-87:2021
Edition 2021-10

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