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Spec:
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Title:
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ISO 10993-1
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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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ISO 10993-2
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Biological evaluation of medical devices - Part 2: Animal welfare requirements
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ISO 10993-3
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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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ISO 10993-4
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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
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ISO-10993-4 Amendment 1
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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1
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ISO 10993-5
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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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ISO-10993-6
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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
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ISO 10993-7
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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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ISO 10993-9
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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
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ISO 10993-10
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Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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ISO 10993-11
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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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ISO 10993-12
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Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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ISO 10993-13
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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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ISO 10993-14
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Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
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ISO 10993-15
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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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ISO 10993-16
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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
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ISO 10993-17
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Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
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ISO 10993-18
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Biological evaluation of medical devices - Part 18: Chemical characterization of materials
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ISO 10993-19
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Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
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ISO 10993-20
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Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
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