EN ISO 14602:2011
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Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
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EN 556:1994 + A1:1998
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STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
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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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EN 550 : 1994
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
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EN 27740:1992/A1:1997
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INSTRUMENTS FOR SURGERY, SCALPELS WITH DETACHABLE BLADES, FITTING DIMENSIONS
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EN 30993-4 : 1993
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
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EN ISO 10993-11:2009
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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
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EN 1441 : 1997
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MEDICAL DEVICES - RISK ANALYSIS
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ISO 7151:1988
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Surgical instruments Non-cutting, articulated instruments General requirements and test methods
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EN 46001 : 1996
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QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
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EN 30993-3 : 1993
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
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EN 540 : 1993
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
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EN 868-1 : 1997
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PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
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EN 724 : 1994
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GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
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EN 1174-1 : 1996
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STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
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EN 12010 : 1998
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NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
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ISO 4957:1999
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Tool steels
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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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EN ISO 10993-10:2013
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Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
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EN ISO 10993-7 : 2008 COR 2009
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009)
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ISO 14630:2012
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Non-active surgical implants General requirements
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EN 30993-6 : 1994
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
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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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EN 60068-2-27:2009
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Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
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ISO 14602:2010
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Non-active surgical implants — Implants for osteosynthesis — Particular requirements
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EN 552:1994/A2:2000
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
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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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ISO 10993-11:2017
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Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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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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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 46002 : 1996
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QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
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ISO 7153-1:2016
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Surgical instruments Materials Part 1: Metals
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ISO 7740:1985
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Instruments for surgery Scalpels with detachable blades Fitting dimensions
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EN ISO 10993-12:2012
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Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
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ISO 8319-2:1986
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Orthopaedic instruments — Drive connections — Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws
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EN 30993-5 : 1994
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR CYTOTOXICITY - IN VITRO METHODS
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EN 60068-2-32:1993
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Basic environmental testing procedures - Part 2: Tests - Test Ed: Free fall
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EN 980:2008
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Symbols for use in the labelling of medical devices
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EN ISO 10993-1:2009/AC:2010
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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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
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EN 554 : 1994
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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EN ISO 14630:2012
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Non-active surgical implants - General requirements (ISO 14630:2012)
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EN 60068-2-47:2005
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Environmental testing - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests
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