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Standards [New]

DIN EN IEC 61223-3-5

Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests and constancy tests - Imaging performance of computed tomography X-ray equipment (IEC 61223-3-5:2019 + Cor. 1:2022); German version EN IEC 61223-3-5:2019 + AC:2022
Edition 2024-07

Technical Specification [CURRENT]

DIN CEN ISO/TS 19293 ; DIN SPEC 13239:2018-08

Health Informatics - Requirements for a record of the dispense of a medicinal product (ISO/TS 19293:2018); English version CEN ISO/TS 19293:2018
Edition 2018-08

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

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

Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement (CISPR 11:2015, modified + A1:2016 + A2:2019); German version EN 55011:2016 + A1:2017 + A11:2020 + A2:2021
Edition 2022-05

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (IEC 60601-2-22:2019); German version EN IEC 60601-2-22:2020
Edition 2022-10

Medical Electrical Equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment (IEC 80601-2-60:2019); German version EN IEC 80601-2-60:2020
Edition 2021-09

Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:2011); German version EN 60601-2-23:2015
Edition 2016-08

Draft standard

DIN EN 17180

Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023
Edition 2023-03

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (IEC 60601-2-57:2011); German version EN 60601-2-57:2011
Edition 2011-11

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