ONORM EN ISO 10993-11 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
CSA ISO 10993-10 : 0
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SENSITIZATION |
I.S. EN ISO 5840:2009
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
DD ISO/TS 10993-20:2006
|
Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices |
ANSI/AAMI/ISO 10993-3:2014
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY |
BS EN ISO 5840-2:2015
|
Cardiovascular implants. Cardiac valve prostheses Surgically implanted heart valve substitutes |
ISO/TS 20993:2006
|
Biological evaluation of medical devices Guidance on a risk-management process |
04/30103836 DC : DRAFT JUL 2004
|
ISO 11979-5 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
DIN EN ISO 12417-1:2016-02
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
AAMI ISO 10993-11 : 2006 : R2014
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
BS ISO 18562-4:2017
|
Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate |
09/30140724 DC : 0
|
BS ISO 26000 - GUIDANCE ON SOCIAL RESPONSIBILITY |
14/30295067 DC : 0
|
BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
03/100426 DC : DRAFT JAN 2003
|
BS EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
00/561676 DC : DRAFT APRIL 2000
|
DRAFT BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
ISO 10993-11:2017
|
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
11/30212473 DC : 0
|
BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
08/30187781 DC : DRAFT AUG 2008
|
BS EN ISO 10993-16 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
AAMI ISO 10993-1 : 2009 : R2013
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
06/30106186 DC : 0
|
ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
CSA ISO 14971 : 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
DIN EN ISO 5840-3:2013-06
|
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
ONORM EN ISO 5840-3 : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
BS EN ISO 10993-16:2017
|
Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables |
ANSI/AAMI/ISO 5840-3:2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
UNE-EN ISO 22442-1:2016
|
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
I.S. EN ISO 10993-11:2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY (ISO 10993-11:2006) |
I.S. EN ISO 10993-16:2017
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES (ISO 10993-16:2010) |
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
ISO 7405:2008
|
Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
DIN EN ISO 11979-5:2010-11
|
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
DIN EN ISO 22442-1:2016-05
|
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
DIN EN ISO 10993-10 E : 2003
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
DIN EN ISO 10993-11 E : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
EN ISO 10993-9:2009
|
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
BS EN ISO 10993-1 : 2009-10
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
ISO 10993-9:2009
|
Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
BS EN ISO 22803:2005
|
Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file |
UNE-EN ISO 10993-6:2017
|
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016) |
ISO 9394:2012
|
Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes |
BS EN ISO 9394:2012
|
Ophthalmic optics. Contact lenses and contact lens care products. Determination of biocompatibility by ocular study with rabbit eyes |
UNE-EN ISO 16672:2016
|
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
BS EN ISO 10993-3:2014
|
Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity |
EN 12011 : 1998
|
INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
ONORM EN ISO 10993-10 : 2014
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
ANSI Z80.27 : 2014
|
OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES |
ONORM EN ISO 11979-5 : 2010
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
ONORM EN ISO 10993-1 : 2011
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
I.S. EN ISO 15798:2013
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
DIN ISO 26000:2011-01
|
Guidance on social responsibility (ISO 26000:2010) |
13/30286759 DC : 0
|
BS ISO GUIDE 82 - GUIDE FOR ADDRESSING SUSTAINABILITY IN STANDARDS |
ISO/TS 22911:2016
|
Dentistry Preclinical evaluation of dental implant systems Animal test methods |
I.S. EN ISO 5840-3:2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
17/30344601 DC : 0
|
BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
14/30281560 DC : 0
|
BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES |
CSA ISO 26000 : 2016
|
GUIDANCE ON SOCIAL RESPONSIBILITY |
AAMI ISO 12417-1 : 2015
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
03/103026 DC : DRAFT JAN 2003
|
BS EN ISO 5840 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
ANSI Z80.13 : 2007
|
OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
AAMI ISO 5840 : 2005 : R2010
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
15/30290736 DC : 0
|
BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
AAMI ISO 5840 :2005
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
UNI EN ISO 5840-3 : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
ASTM D 6324 : 2011
|
Standard Test Methods for Male Condoms Made from Polyurethane |
BS EN ISO 10993-11:2009
|
Biological evaluation of medical devices Tests for systemic toxicity |
AAMI BE83 : 2006
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
I.S. EN ISO 12417-1:2015
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
ISO 18562-4:2017
|
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate |
BS ISO 26000:2010
|
Guidance on social responsibility |
ISO/TR 37137:2014
|
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants |
ONORM EN ISO 7405 : 2013
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD 1:2013) |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
CEI UNI EN ISO 14971 : 2013
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
UNI EN ISO 10993-11 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
I.S. EN ISO 14971:2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
DIN EN ISO 22803:2006-01
|
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
DIN EN ISO 10993-18:2009-08
|
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009 |
DIN EN ISO 14971:2013-04
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
DIN EN ISO 16672:2015-12
|
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
DIN EN ISO 9394:2013-01
|
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 E : 2016
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
EN ISO 10993-1:2009/AC:2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010) |
BS EN ISO 10993-6:2016
|
Biological evaluation of medical devices Tests for local effects after implantation |
UNE-EN ISO 10993-10:2013
|
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
BS EN 1441:1998
|
Medical devices. Risk analysis |
BS EN ISO 22442-1:2015
|
Medical devices utilizing animal tissues and their derivatives Application of risk management |
BS EN ISO 10993-9 : 2009-12
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
I.S. EN ISO 10993-6:2016
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
EN ISO 5840-2:2015
|
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
I.S. EN ISO 22794:2009
|
DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
UNI EN ISO 10993-18 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
I.S. EN ISO 9394:2012
|
OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES (ISO 9394:2012) |
I.S. EN ISO 22442-1:2015
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
I.S. EN ISO 10993-3:2014
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014) |
EN ISO 22442-1:2015
|
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
EN ISO 5840-3:2013
|
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
I.S. EN ISO 10993-10:2013
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
I.S. EN ISO 16672:2015
|
OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015) |
OVE/ONORM EN 60601-1 : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
UNE-EN ISO 5840-2:2016
|
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
ISO 10993-16:2017
|
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
11/30243462 DC : 0
|
BS EN ISO 9394 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES |
ISO 5910:2018
|
Cardiovascular implants and extracorporeal systems Cardiac valve repair devices |
17/30343686 DC : 0
|
BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
BS EN ISO 12417-1:2015
|
Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements |
BS ISO 27427:2013
|
Anaesthetic and respiratory equipment. Nebulizing systems and components |
AAMI ISO 10993-1:2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
ANSI Z80.29 : 2015
|
OPHTHALMICS - ACCOMODATIVE INTRAOCULAR LENSES |
BS EN ISO 5840-3:2013
|
Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques |
08/30178723 DC : DRAFT AUG 2008
|
BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES |
03/101659 DC : DRAFT JAN 2003
|
ISO 22803 - DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
ANSI/AAMI/ISO 22442-1:2016
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
DIN EN ISO 5840-2:2016-05
|
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
I.S. ISO 26000:2010
|
GUIDANCE ON SOCIAL RESPONSIBILITY |
CSA ISO 10993-9 : 0
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
EN ISO 16671:2015/A1:2017
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017) |
AAMI ISO 10993-10 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
ANSI/AAMI/ISO 10993-6:2016
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
I.S. EN ISO 5840-2:2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
ANSI/AAMI/ISO TIR10993-20:2006
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES |
EN ISO 10993-11:2009
|
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
I.S. EN ISO 7405:2009
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
ISO 16671:2015
|
Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
ISO 15798:2013
|
Ophthalmic implants Ophthalmic viscosurgical devices |
BS EN ISO 14971:2012
|
Medical devices. Application of risk management to medical devices |
I.S. EN ISO 16671:2015
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |
ISO 10993-18:2005
|
Biological evaluation of medical devices Part 18: Chemical characterization of materials |
DIN EN ISO 22794:2009-11
|
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
DIN EN ISO 10993-3:2015-02
|
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
|
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009) |
DIN EN ISO 11979-5 E : 2010
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
UNE-EN ISO 10993-3:2015
|
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
ISO 10993-3:2014
|
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
BS EN ISO 10993-18:2009
|
Biological evaluation of medical devices Chemical characterization of materials |
ISO 5840:2005
|
Cardiovascular implants Cardiac valve prostheses |
BS EN ISO 10993-10:2013
|
Biological evaluation of medical devices Tests for irritation and skin sensitization |
DIN EN ISO 10993-10:2014-10
|
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
ISO 22794:2007
|
Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file |
I.S. EN ISO 10993-18:2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005) |
EN ISO 10993-18:2009
|
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
I.S. EN ISO 11979-5:2006
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
EN ISO 11979-5:2006
|
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
I.S. EN ISO 10993-9:2009-12
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS (ISO 10993-9:2009) |
UNI EN ISO 5840 : 2009
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
UNI EN ISO 10993-10 : 2013
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
ONORM EN ISO 15798 : 2013 AMD 1 2018
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
UNI EN ISO 10993-3 : 2015
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
CSA ISO 10993-11 : 0
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TEST FOR SYSTEMIC TOXICITY |
BS EN ISO 7405 : 2008
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
UNI EN ISO 9394 : 2013
|
OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES |
UNI EN ISO 10993-1 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
DIN EN ISO 12417-1 E : 2016
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
I.S. EN 12011:1998
|
INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
14/30295064 DC : 0
|
BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES |
UNE-ISO 26000:2012
|
Guidance on social responsibility |
11/30219211 DC : 0
|
BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES |
14/30261590 DC : 0
|
BS EN ISO 10993-6 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
08/30170164 DC : DRAFT AUG 2008
|
BS EN ISO 10993-10 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
UNI CEI EN ISO 14971 : 2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA ISO 27427 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
ANSI Z80.13 : 2007 : R2017
|
OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
UNE-EN ISO 12417-1:2016
|
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
AAMI ISO 10993-16:2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
AAMI ISO 14971 : 2007 : R2010
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
AAMI BE78 : 2002
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY |
CSA ISO 10993-6 : 1997(R2009)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
ANSI/AAMI/ISO 10993-9:2009(R2014)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
I.S. EN ISO 25539-1:2017
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
ASTM D 6324 : 2011 : R2017
|
Standard Specification for Male Condoms Made from Polyurethane |
DIN EN ISO 7405:2013-12
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013) |
ASTM F 2695 : 2012 : REDLINE
|
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
EN ISO 14971:2012
|
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
UNI EN ISO 7405 : 2013
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
BS EN ISO 16671 : 2015
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OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
ISO/TS 10993-20:2006
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Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices |
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) |
BS EN ISO 11979-5:2006
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Ophthalmic implants. Intraocular lenses Biocompatibility |
ISO 26000:2010
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Guidance on social responsibility |
DIN EN ISO 9394 E : 2013
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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) |
BS EN 12011:1998
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Instrumentation to be used in association with non-active surgical implants. General requirements |
ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
BS EN 30993-6:1995
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Biological evaluation of medical devices Tests for local effects after implantation |
ISO 5840-3:2013
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Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques |
ISO 16672:2015
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Ophthalmic implants Ocular endotamponades |
UNE-EN ISO 9394:2013
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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) |
ISO 11979-5:2006
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Ophthalmic implants Intraocular lenses Part 5: Biocompatibility |
I.S. 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) |
ISO 10993-10:2010
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Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
ISO 5840-2:2015
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Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes |
AAMI ISO 10993-4 : 2002
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
BS EN ISO 5840:2009
|
Cardiovascular implants. Cardiac valve prostheses |
ISO 12417-1:2015
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Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
UNE-EN ISO 10993-9:2010
|
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
BS EN 30993-3:1994
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Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity |
BS EN ISO 22794:2009
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Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file |
EN ISO 10993-6:2016
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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016) |
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) |
EN ISO 22803:2005
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Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
EN 30993-6 : 1994
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
EN ISO 22794:2009
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Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
EN ISO 10993-3:2014
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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
EN 30993-3 : 1993
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
EN ISO 9394:2012
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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) |
EN 1441 : 1997
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MEDICAL DEVICES - RISK ANALYSIS |
EN ISO 12417-1:2015
|
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
AAMI ISO 10993-9 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
ANSI/AAMI/ISO 10993-10:2010(R2014)
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
UNE-EN ISO 5840-3:2013
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Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
16/30335531 DC : 0
|
BS EN ISO 10993-16 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
PD ISO/TR 37137:2014
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Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants |
ANSI/AAMI BE83:2006(R2011)
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
07/30163763 DC : 0
|
BS ISO 7405 - DENTISTRY - PRECLINICAL EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY - TEST METHODS FOR DENTAL MATERIALS |
16/30310949 DC : 0
|
BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
CSA ISO 5840 : 0
|
CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES |
ANSI Z80.30 : 2010
|
OPHTHALMICS - TORIC INTRAOCULAR LENSES |
07/30162839 DC : 0
|
BS EN ISO 10993-9 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
02/560790 DC : DRAFT FEB 2002
|
BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
ANSI Z80.13 : 2007 : R2012
|
OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
AAMI ISO 10993-16 : 2010 : R2014
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
ANSI Z80.12 : 2007 : R2017
|
OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES |
ANSI Z80.12 : 2007
|
OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES |
CSA ISO 14971 : 2007 : R2017
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA ISO 14971 : 2007 : R2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
UNE-EN ISO 16671:2016
|
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) |
ONORM EN ISO 5840-2 : 2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
DIN EN ISO 10993-11:2015-12 (Draft)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
ISO Guide 82:2014
|
Guidelines for addressing sustainability in standards |
EN ISO 10993-16:2017
|
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017) |
UNI ISO 26000 : 2010
|
GUIDANCE ON SOCIAL RESPONSIBILITY |
EN ISO 15798:2013/A1:2017
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017) |
UNI EN ISO 22794 : 2009
|
DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
CSA ISO 10993-3 : 1997
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
EN ISO 7405:2008/A1:2013
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
NF EN ISO 10993-1 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM PROCESS |
ISO 27427:2013
|
Anaesthetic and respiratory equipment — Nebulizing systems and components |
DIN EN ISO 10993-18 E : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
DIN EN ISO 10993-6:2009-08
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
ISO 10993-6:2016
|
Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
ISO 22803:2004
|
Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file |
BS EN ISO 16672:2015
|
Ophthalmic implants. Ocular endotamponades |
DIN EN ISO 5840:2009-08
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
UNI EN ISO 10993-9 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
ONORM EN ISO 10993-9 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
DIN EN ISO 10993-11:2009-08
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
EN ISO 5840:2009
|
Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) |
DIN EN ISO 10993-6:2017-09
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
DIN EN ISO 10993-10:2003-02
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |