GB - Chinese national standards

Biological evaluation of medical devices—Part 10:Tests for skin sensitization

Available languages: English, Chinese

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Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

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Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

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Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

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

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

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

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Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents

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Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process

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

Available languages: English, Chinese

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