MDD Horizontal Standards


EN ISO 10993-14

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics

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EN ISO 10993-15

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

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EN ISO 10993-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

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EN ISO 10993-17

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

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EN ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of materials

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EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice

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EN 1707

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings

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EN ISO 5359

Low-pressure hose assemblies for use with medical gases

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EN ISO 7396-1

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum

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EN ISO 7396-2

Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems

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