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Standards [CURRENT]

OVE EN 60601-2-33

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010 + COR1:2012 + A1:2013 + A2:2015 + COR2:2016) (german version)
Edition 2017-12-01

Standards [CURRENT]

OVE EN IEC 60601-2-35

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (( IEC 60601-2-35:2020) EN IEC 60601-2-35:2021) (german version)
Edition 2022-11-01

Standards [CURRENT]

ISO 11137-1 AMD 2

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2
Edition 2018-11

Technical rule [CURRENT]

ISO/IEC Guide 63

Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Edition 2019-08

Pre-standard

ISO/TS 10974

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
Edition 2018-04

Technical rule [CURRENT]

ISO/TR 24291

Health informatics - Applications of machine learning technologies in imaging and other medical applications
Edition 2021-03

Standards [CURRENT]

OVE EN IEC 60580

Medical electrical equipment - Dose area product meters (german version)
Edition 2023-05-01

Standards [CURRENT]

SN EN 60731+A1

Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
Edition 2022-08

Standards [CURRENT]

SN EN 864

Medical electrical equipment - Capnometer for use with humans - Particular requirements
Edition 1997

Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance
Edition 1995-05-01

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