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Standards [CURRENT]

SN EN IEC 80601-2-26

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
Edition 2020-04

Standards [CURRENT]

SN EN ISO 8637-2

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
Edition 2024-04

Standards [CURRENT]

SN EN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)
Edition 2024-06

Standards [CURRENT]

SN EN ISO 18113-2

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
Edition 2024-06

Standards [CURRENT]

SN EN ISO 18113-3

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)
Edition 2024-06

Technical rule [CURRENT]

ONR CEN ISO/TS 20440

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2023)
Edition 2023-10-15

Non-active surgical implants - Injectable implants
Edition 2006-12-01

Draft standard

OENORM EN 17122/A1

Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements - Phase 2, step2 (Amendment)
Edition 2023-03-15

Draft standard

OENORM EN ISO 22675

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO/DIS 22675:2021)
Edition 2022-02-01

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO/DIS 18562-4:2022)
Edition 2022-12-01

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