CSA C22.2 No. 80601-2-56 : 2012
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
I.S. EN ISO 5840:2009
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
I.S. EN ISO 14155-2:2009
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
I.S. EN ISO 22523:2006
|
EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
I.S. EN ISO 22442-3:2007
|
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 |
DIN EN ISO 7197:2009-08
|
NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
05/30106198 DC : 0
|
EN ISO 22442-3 - 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 |
ANSI Z80.12 : 2007 : R2017
|
OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES |
AAMI ISO 22442-3:2007
|
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 |
ASTM F 2560 : 2006
|
Standard Specification for Supralaryngeal Airways and Connectors |
ANSI Z80.13 : 2007 : R2012
|
OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
I.S. CEN TS 15277:2006
|
NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
CSA ISO 14971 : 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA Z9919 : 2007 : R2012
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
DIN EN ISO 14607:2009-08
|
NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS |
BIS IS/ISO 11979-8 : 2006
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
ASTM F 2761 : 2009 : R2013
|
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
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 1642:2012-06
|
Dentistry - Medical devices for dentistry - Dental implants |
BS EN ISO 22803:2005
|
Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file |
BS EN ISO 22523:2006
|
External limb prostheses and external orthoses. Requirements and test methods |
DIN EN ISO 14155-2:2003-09
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
CEN ISO/TR 14969:2005
|
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) |
DIN EN ISO 21649:2010-01
|
Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
EN ISO 22523 : 2006
|
EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006) |
NF EN ISO 21649 : 2009
|
NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
ANSI Z80.27 : 2014
|
OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES |
16/30310656 DC : 0
|
BS EN ISO 18369-1 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS |
DIN EN ISO 21534 E : 2009
|
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
ANSI Z80.11:2012
|
OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
08/30138762 DC : DRAFT APR 2008
|
BS EN ISO 11980 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS |
06/30160368 DC : 0
|
BS EN 80100 - BASIC SAFETY AND ESSENTIAL PERFORMANCE REQUIREMENTS OF CLINICAL THERMOMETER FOR BODY TEMPERATURE MEASUREMENT |
ANSI Z80.13 : 2007
|
OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
AAMI ISO 5840 : 2005 : R2010
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
AAMI ISO 5840 :2005
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
CSA C22.2 No. 80601-2-56 : 2012 : R2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
AAMI ISO 22442-3 : 2007 : R2011
|
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 |
ISO 11712:2009
|
Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors |
AAMI ISO 14155-2 : 2003
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
UNE-EN 50527-2-1:2012
|
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers |
CSA ISO 11712:14 (R2019)
|
Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15) |
UNI EN ISO 14607 : 2009
|
NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS |
BS EN ISO 14607:2009
|
Non-active surgical implants. Mammary implants. Particular requirements |
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
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 1641:2010-02
|
Dentistry - Medical devices for dentistry - Materials |
DIN EN ISO 22442-3:2008-03
|
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 |
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 1640:2010-02
|
Dentistry - Medical devices for dentistry - Equipment |
DIN EN ISO 14971:2013-04
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
BS EN 14299:2004
|
Non-active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents |
BS EN 1640:2009
|
Dentistry. Medical devices for dentistry. Equipment |
BS EN ISO 7439:2015
|
Copper-bearing contraceptive intrauterine devices. Requirements and tests |
BS EN 1639:2009
|
Dentistry. Medical devices for dentistry. Instruments |
UNE-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 22794:2009
|
DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
I.S. EN ISO 21649:2009
|
NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
DIN EN 1060-4:2004-12
|
NON-INVASIVE SPHYGMOMANOMETERS - PART 4: TEST PROCEDURES TO DETERMINE THE OVERALL SYSTEM ACCURACY OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
I.S. EN ISO 7439:2015
|
COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015) |
I.S. EN 1642:2011
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
I.S. EN 1640:2009
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
I.S. EN 1639:2009
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
I.S. EN 1641:2009
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
I.S. EN ISO 10451:2010
|
DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
I.S. EN ISO 10993-10:2013
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
UNI EN 1642 : 2012
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
BIS IS/ISO 14708-3 : 2008
|
IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS |
DIN EN 14299:2004-08
|
NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS |
VDI 3823 Blatt 4:2006-11
|
Vacuum coating quality assurance - Testing of vacuum coated plastics |
ISO 13019:2018
|
Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis |
09/30197590 DC : 0
|
BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
I.S. EN ISO 9919:2009
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
BS EN ISO 7197:2009
|
Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components |
17/30319534 DC : 0
|
BS ISO 13019 - TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULPHATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS |
DIN EN ISO 21534:2009-08
|
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
BS PD ISO/TR 14969 : 2004 AMD 15958
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
04/300654 DC : DRAFT JAN 2004
|
BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
CSA ISO 11712 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS |
ANSI Z80.29 : 2015
|
OPHTHALMICS - ACCOMODATIVE INTRAOCULAR LENSES |
09/30207531 DC : 0
|
BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
AAMI ISO TIR 14969 : 2004
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
BS EN ISO 21534:2009
|
Non-active surgical implants. Joint replacement implants. Particular requirements |
14/30257644 DC : 0
|
BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
08/30178723 DC : DRAFT AUG 2008
|
BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES |
04/30088722 DC : DRAFT APR 2004
|
ISO 18369-1 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: TERMINOLOGY |
CSA Z9919 :2007
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
UNE-EN ISO 80601-2-56:2013
|
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009) |
AAMI ISO 10993-10 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
NF EN ISO 14607 : 2009
|
NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS |
ISO/TR 14969:2004
|
Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
I.S. EN ISO 7197:2009
|
NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
BS EN ISO 14971:2012
|
Medical devices. Application of risk management to medical devices |
DIN EN ISO 22523:2007-04
|
External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
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 1639:2010-02
|
Dentistry - Medical devices for dentistry - Instruments |
DIN EN ISO 7439:2015-08
|
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
BS EN ISO 9919:2009
|
Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
BS EN ISO 21649:2009
|
Needle-free injectors for medical use. Requirements and test methods |
ISO 7197:2006
|
Neurosurgical implants Sterile, single-use hydrocephalus shunts and components |
BS EN ISO 14155-2:2009
|
Clinical investigation of medical devices for human subjects Clinical investigation plans |
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) |
UNE-EN ISO 7439:2015
|
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
ISO 21649:2006
|
Needle-free injectors for medical use — Requirements and test methods |
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 |
UNI EN 1641 : 2010
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
UNI EN 1640 : 2010
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
UNI EN ISO 10451 : 2010
|
DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
UNI EN 1639 : 2010
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
UNI EN ISO 14155-2 : 2009
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
EN ISO 9919:2009
|
Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) |
UNI EN ISO 9919 : 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
UNI EN ISO 21534 : 2009
|
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
08/30192448 DC : DRAFT DEC 2008
|
BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
UNI CEN/TS 15277 : 2007
|
NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
UNI EN ISO 21649 : 2009
|
NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
BS ISO 11712:2009
|
Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors |
I.S. CEN ISO TR 14969:2005
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003 |
11/30219211 DC : 0
|
BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES |
CEI UNI EN ISO 14971 : 2013
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
PREN ISO 80601-2-55 : DRAFT 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
08/30170164 DC : DRAFT AUG 2008
|
BS EN ISO 10993-10 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
15/30321270 DC : 0
|
BS EN 50527-2-1 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIAC PACEMAKERS |
UNI EN ISO 7197 : 2009
|
NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
UNI CEI EN ISO 14971 : 2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA ISO TR 14969 : 2005 : R2015
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
AAMI ISO 14708-4 : 2008
|
IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
ANSI Z80.13 : 2007 : R2017
|
OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
CSA ISO TR 14969 :2005
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
ANSI Z80.11 : 2012 : R2017
|
OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
ASTM F 2726 : 2008
|
Standard specification for fixation devices for tracheal tubes and other airway devices |
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 |
I.S. EN ISO 21534:2009
|
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
ISO 13485 - PRACTICAL GUIDE : 2016
|
ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE |
ISO 14708-4:2008
|
Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps |
EN ISO 14971:2012
|
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
DIN EN ISO 21649 E : 2010
|
NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
BS EN ISO 22442-3:2007
|
Medical devices utilizing animal tissues and their derivatives Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
ISO 21534:2007
|
Non-active surgical implants Joint replacement implants Particular requirements |
ISO 14155-2:2003
|
Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
UNE-EN 1642:2012
|
Dentistry - Medical devices for dentistry - Dental implants |
ISO 22442-3:2007
|
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 |
ISO 7439:2015
|
Copper-bearing contraceptive intrauterine devices — Requirements and tests |
ISO 22523:2006
|
External limb prostheses and external orthoses — Requirements and test methods |
ISO 10993-10:2010
|
Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
BS EN ISO 5840:2009
|
Cardiovascular implants. Cardiac valve prostheses |
BS EN ISO 10451:2010
|
Dentistry. Contents of technical file for dental implant systems |
ISO 10451:2010
|
Dentistry — Contents of technical file for dental implant systems |
UNE-EN ISO 11979-8:2017
|
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017) |
BS EN 1641:2004
|
Dentistry. Medical devices for dentistry. Materials |
EN ISO 21649:2009
|
Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
EN ISO 10993-10:2013
|
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
EN ISO 7197:2009
|
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
EN ISO 22803:2005
|
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
EN ISO 14155-2:2009
|
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
EN 1641:2009
|
Dentistry - Medical devices for dentistry - Materials |
EN 1642:2011
|
Dentistry - Medical devices for dentistry - Dental implants |
EN 14299 : 2004
|
NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS |
EN 1639:2009
|
Dentistry - Medical devices for dentistry - Instruments |
EN ISO 10451:2010
|
Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
EN ISO 22794:2009
|
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 1640:2009
|
Dentistry - Medical devices for dentistry - Equipment |
EN ISO 7439:2015
|
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
ANSI/AAMI/ISO 10993-10:2010(R2014)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
PD CEN ISO/TR 14969:2005
|
Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 |
ANSI Z80.30 : 2010
|
OPHTHALMICS - TORIC INTRAOCULAR LENSES |
06/30094541 DC : DRAFT JUN 2006
|
ISO 21534 - NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS |
02/560790 DC : DRAFT FEB 2002
|
BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
CSA ISO TR 14969 : 2005 : R2010
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
AAMI ISO 14708-4:2008(R2011)
|
IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
04/30103843 DC : DRAFT JUL 2004
|
ISO 11979-7 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS |
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 |
DIN EN ISO 10451:2010-11
|
Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
ISO 22803:2004
|
Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file |
BS EN 1060-4:2004
|
Non-invasive sphygmomanometers Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
BS EN 1642:2011
|
Dentistry. Medical devices for dentistry. Dental implants |
ISO 9919:2005
|
Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
DIN EN ISO 5840:2009-08
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
DIN EN ISO 14155-2:2009-11
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
CEN/TS 15277:2006
|
Non-active surgical implants - Injectable implants |
EN 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 (ISO 22442-3:2007) |
EN ISO 21534:2009
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Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007) |
EN ISO 5840:2009
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Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) |
EN 1060-4 : 2004
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NON-INVASIVE SPHYGMOMANOMETERS - PART 4: TEST PROCEDURES TO DETERMINE THE OVERALL SYSTEM ACCURACY OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
DIN EN ISO 10993-10:2003-02
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |