ISO 10993-3:2014
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Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
ISO 10993-4:2017
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Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
ISO 10993-16:2017
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Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
ISO/TS 10993-20:2006
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Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices |
ISO 10993-13:2010
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Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
ISO 10993-2:2006
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Biological evaluation of medical devices — Part 2: Animal welfare requirements |
ISO 7405:2008
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Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
ISO 10993-14:2001
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Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics |
ISO 10993-18:2005
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Biological evaluation of medical devices Part 18: Chemical characterization of materials |
ISO/TS 10993-19:2006
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Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials |
ISO 10993-10:2010
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Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
ISO 9004:2009
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Managing for the sustained success of an organization A quality management approach |
ISO 10993-11:2017
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Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
ISO 10993-12:2012
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Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
ISO 10993-17:2002
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Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
ISO 9001:2015
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Quality management systems — Requirements |
ISO 10993-9:2009
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Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO 10993-6:2016
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Biological evaluation of medical devices Part 6: Tests for local effects after implantation |