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Draft standard

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/DIS 80601-2-79:2023); German and English version prEN ISO 80601-2-79:2023
Edition 2023-06

Draft standard

DIN EN ISO 11135

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024
Edition 2024-04

Standards [Pre-order]

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

Draft standard

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/DIS 80601-2-80:2023); German and English version prEN ISO 80601-2-80:2023
Edition 2023-07

Standards [CURRENT]

DIN EN ISO/IEEE 11073-10419

Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019); English version EN ISO/IEEE 11073-10419:2023
Edition 2023-11

Technical Report Draft [New]

DIN/TR 13284

Thrombin generation assay; Text in German and English
Edition 2024-06

Technical Specification

DIN CEN ISO/TS 14265

Health informatics - Classification of purposes for processing personal health information (ISO/TS 14265:2024); English version CEN ISO/TS 14265:2024
Edition 2024-04

Technical Specification

DIN CEN ISO/TS 11137-4

Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020); German version CEN ISO/TS 11137-4:2023
Edition 2023-10

Technical Specification [New]

DIN CEN ISO/TS 5499

Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers (ISO/TS 5499:2024); English version CEN ISO/TS 5499:2024
Edition 2024-05

Technical Specification [New]

DIN CEN/TS 17981-2

In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination; German version CEN/TS 17981-2:2023
Edition 2024-05

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Gesundheitstechnologien ISO/TC215 CEN/TC251 Medication Funktionsweise healthcard

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