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Standards [CURRENT]

DIN EN ISO 20789

Anaesthetic and respiratory equipment - Passive humidifiers (ISO 20789:2018); German version EN ISO 20789:2019
Edition 2020-02

Draft standard

DIN EN ISO 18362

Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018
Edition 2018-11

Draft standard

DIN EN ISO 14630

Non-active surgical implants - General requirements (ISO/DIS 14630:2022); German and English version prEN ISO 14630:2022
Edition 2022-10

Draft standard

DIN EN IEC 61223-3-8

Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Radiography and radioscopy (IEC/CDV 61223-3-8:2022); German and English version prEN IEC 61223-3-8:2022
Edition 2023-06

Standards [CURRENT]

DIN EN ISO 17664-2

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German version EN ISO 17664-2:2023
Edition 2024-04

Standards [CURRENT]

DIN EN ISO 80369-3

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016 + Amd 1:2019); German version EN ISO 80369-3:2016 + A1:2022
Edition 2023-02

Draft standard [New]

DIN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024
Edition 2024-08

Standards [CURRENT]

DIN ISO 13022

Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
Edition 2014-06

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

Draft standard

DIN EN ISO 25539-3

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO/DIS 25539-3:2023); German and English version prEN ISO 25539-3:2023
Edition 2023-08

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