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ISO 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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ISO 10993-3:2014
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Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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ISO 10993-4:2017
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Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
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ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
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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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ISO 14155-2:2003
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Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
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ISO 13779-1:2008
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Implants for surgery Hydroxyapatite Part 1: Ceramic hydroxyapatite
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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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DIN EN ISO 11137-1:2015-11
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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)
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DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
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ISO 10993-2:2006
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Biological evaluation of medical devices — Part 2: Animal welfare requirements
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ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
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ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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ISO 14630:2012
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Non-active surgical implants General requirements
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ISO/TR 14283:2004
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Implants for surgery Fundamental principles
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EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices
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DIN EN ISO 17665-1:2006-11
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Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
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DIN EN ISO 14155-1:2009-11
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
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ISO 10993-10:2010
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Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
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DIN EN 980:2008-08
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SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
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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 1942:2009
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Dentistry Vocabulary
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ISO 10993-11:2017
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Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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DIN EN ISO 11607-2:2014-11
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014)
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|
ISO 10993-12:2012
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Biological evaluation of medical devices Part 12: Sample preparation and reference materials
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DIN EN ISO 11135-1:2007-08
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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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 10993-17:2002
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Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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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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ISO 22442-2:2015
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Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
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ISO 10993-9:2009
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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 22442-3:2007
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Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
|
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DIN EN ISO 1942:2011-03
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Dentistry - Vocabulary (ISO 1942:2009, Corrected version 2010-03-01)
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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|
DIN EN ISO 14155-2:2009-11
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
|
|
EN 980:2008
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Symbols for use in the labelling of medical devices
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|
DIN EN ISO 10993-17:2009-08
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Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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ISO 10993-6:2016
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Biological evaluation of medical devices Part 6: Tests for local effects after implantation
|
|
ISO 17665-1:2006
|
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
|
|
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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