EN 12442-3 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
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ISO 14160:2011
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Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
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IEC 60068-2-27:2008
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Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
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ISO 11135:2014
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Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
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EN 12006-2:1998+A1:2009
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Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
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ISO 21534:2007
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Non-active surgical implants Joint replacement implants Particular requirements
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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ISO 14937:2009
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Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
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ISO 14155-1:2003
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Clinical investigation of medical devices for human subjects Part 1: General requirements
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ISO 21536:2007
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Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
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ISO/TR 14283:2004
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Implants for surgery Fundamental principles
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ISO 14602:2010
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Non-active surgical implants — Implants for osteosynthesis — Particular requirements
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IEC 60068-2-47:2005
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Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
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ISO 16061:2015
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Instrumentation for use in association with non-active surgical implants General requirements
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ISO 8601:2004
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Data elements and interchange formats Information interchange Representation of dates and times
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ISO 13408-1:2008
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Aseptic processing of health care products — Part 1: General requirements
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ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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EN 12006-3:1998+A1:2009
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Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
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ISO 11607:2003
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Packaging for terminally sterilized medical devices
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EN 12442-1 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
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ISO 7197:2006
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Neurosurgical implants Sterile, single-use hydrocephalus shunts and components
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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ISO 11137:1995
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Sterilization of health care products Requirements for validation and routine control Radiation sterilization
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ISO 14607:2007
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Non-active surgical implants Mammary implants Particular requirements
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ISO 17664:2017
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Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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ISO 12891-1:2015
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Retrieval and analysis of surgical implants Part 1: Retrieval and handling
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EN 12442-2 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
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ISO 21535:2007
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Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
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EN 12006-1 : 1999
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NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - HEART VALVE SUBSTITUTES
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ISO 16429:2004
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Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
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ISO 15223:2000
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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