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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

Standards [CURRENT]

NF S90-014

Medical and surgical equipment. Re-useable glass insulin syringes
Edition 1981-12-01

Standards [CURRENT]

OENORM EN 864

Medical electrical equipment - Capnometers for use with humans - Particular requirements
Edition 1997-04-01

Standards [CURRENT]

OEVE/OENORM EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Edition 2022-02-01

Standards [New]

OENORM EN ISO 15189

Medical laboratories - Requirements for quality and competence (ISO 15189:2022) (consolidated version)
Edition 2024-08-01

Medical electrical equipment - Part 1: general requirements for basic safety and essential performance
Edition 2014-03-19

Medical electrical equipment - Part 1: general requirements for basic safety and essential performance
Edition 2016-08-20

Standards [CURRENT]

SN EN 62304+A1

Medical device software - Software life-cycle processes
Edition 2016-10

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

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