DIN EN ISO 5840-3:2013-06
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Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
DIN EN ISO 11979-5:2010-11
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Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
DIN ISO 26000:2011-01
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Guidance on social responsibility (ISO 26000:2010) |
DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
DIN EN ISO 16672:2015-12
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Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
DIN EN ISO 9394:2013-01
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Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012) |
DIN EN ISO 5840-2:2016-05
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Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
DIN EN ISO 10993-3:2015-02
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014) |
DIN EN ISO 10993-1:2010-04
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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009) |
DIN EN ISO 10993-10:2014-10
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Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
DIN EN ISO 7405:2013-12
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DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013) |
DIN EN ISO 10993-9:2010-04
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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
DIN EN ISO 12417-1:2016-02
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CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
DIN EN ISO 10993-11:2015-12 (Draft)
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
DIN EN ISO 10993-6:2009-08
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
DIN EN ISO 5840:2009-08
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CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |