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Draft standard

OENORM EN 868-2

Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
Edition 2024-05-01

Draft standard

OENORM EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024)
Edition 2024-07-15

Standards [CURRENT]

ISO 3180

Fine ceramics (advanced ceramics, advanced technical ceramics) - Methods for chemical analysis of calcium-phosphate-based powders for non-biomedical applications
Edition 2023-07

Standards [CURRENT]

ISO 4631

Corrosion of metals and alloys - Measurement of the electrochemical critical localized corrosion potential (E-CLCP) for Ti alloys fabricated via additive manufacturing method in simulated biomedical solutions
Edition 2023-11

Pre-standard

SN ENV 737-6

Medical gas pipeline systems - Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum
Edition 2005-04

Pre-standard

OENORM ENV 737-6

Medical gas pipeline systems - Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum
Edition 2003-09-01

Pre-standard

ISO/TS 10993-19

Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
Edition 2020-03

Draft standard

OENORM EN 455-1/A2

Medical gloves for single use - Part 1: Requirements and testing for freedom of holes (Amendment)
Edition 2023-03-01

Standards [CURRENT]

OENORM S 1125-1

Safety officer for magnetic resonance equipment for medical diagnosis - Part 1: Responsibilities and competences
Edition 2009-09-01

Standards [CURRENT]

OENORM S 1125-2

Safety officer for magnetic resonance equipment for medical diagnosis - Part 2: Requirements on training
Edition 2009-09-01

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