ISO 10993-3:2014
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Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
ISO 11346:2014
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Rubber, vulcanized or thermoplastic — Estimation of life-time and maximum temperature of use |
ISO 11737-1:2006
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Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
ISO 188:2011
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Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests |
ISO 2230:2002
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Rubber products — Guidelines for storage |
EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices |
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 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 4074:2015
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Natural rubber latex male condoms Requirements and test methods |
ISO 9001:2015
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Quality management systems — Requirements |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
ISO 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice |
ISO/IEC 17007:2009
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Conformity assessment — Guidance for drafting normative documents suitable for use for conformity assessment |
ISO/TR 8550-1:2007
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Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots Part 1: Acceptance sampling |
ISO/TR 8550-2:2007
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Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots Part 2: Sampling by attributes |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO 29943-2:2017
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Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports |