ISO 14155-2:2003
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
16-03-2019
Superseded by
Language(s)
English
Published date
16-05-2003
Important note : All end users must be registered with an Account prior to user licenses being assigned.
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.
| DevelopmentNote |
Supersedes ISO/DIS 14155-2. (05/2003)
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| DocumentType |
Standard
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| Pages |
9
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 14155-2:2009-11 | Identical |
| AAMI ISO 14155-2 : 2003 | Identical |
| UNE-EN ISO 14155-2:2009 | Identical |
| NF EN ISO 14155-2 : 2009 | Identical |
| GOST R ISO 14155-2 : 2008 | Identical |
| NBN EN ISO 14155-2 : 2009 | Identical |
| NEN EN ISO 14155-2 : 2009 | Identical |
| NS EN ISO 14155-2 : 2009 | Identical |
| I.S. EN ISO 14155-2:2009 | Identical |
| PN EN ISO 14155-2 : 2010 | Identical |
| SN EN ISO 14155-2 : 2010 | Identical |
| UNI EN ISO 14155-2 : 2009 | Identical |
| BS EN ISO 14155-2:2009 | Identical |
| EN ISO 14155-2:2009 | Identical |
| DIN EN ISO 14155-2 E : 2003 | Identical |
| DIN EN ISO 14155-2:2003-09 | Identical |
| UNE-EN ISO 14155-2:2004 | Identical |
| 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 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 |
| 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 |
| 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 |
| ONORM EN ISO 14607 : 2009 | 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 1642:2012-06 | Dentistry - Medical devices for dentistry - Dental implants |
| BS EN ISO 22523:2006 | External limb prostheses and external orthoses. Requirements and test methods |
| DIN EN ISO 14155-1:2003-09 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| DIN EN ISO 21649:2010-01 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| DIN EN ISO 14155-1:2009-11 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| 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 |
| 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 |
| CSA ISO 11712 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS |
| 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 |
| 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 |
| 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 |
| UNI EN ISO 14607 : 2009 | NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS |
| CSA ISO 11712:14 (R2019) | Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15) |
| 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 1639:2010-02 | Dentistry - Medical devices for dentistry - Instruments |
| 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 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 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) |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| 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 1642:2011 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| I.S. EN 1639:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| I.S. EN 1640:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| 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 |
| 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 |
| 01/562226 DC : DRAFT JUNE 2001 | BS EN ISO 14155-1 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| 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 |
| 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 |
| 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 |
| 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 |
| PREN 50527-2-1 : DRAFT 2015 | 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 |
| 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) |
| BS EN ISO 9919:2009 | Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| ISO 7197:2006 | Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components |
| BS EN ISO 21649:2009 | Needle-free injectors for medical use. Requirements and test methods |
| 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 21649:2006 | Needle-free injectors for medical use — Requirements and test methods |
| 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 |
| 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 14155-1 : 2009 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| 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 CEN/TS 15277 : 2007 | NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
| 08/30192448 DC : DRAFT DEC 2008 | BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| UNI EN ISO 21649 : 2009 | NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 14155-1:2009 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| BS EN ISO 14155-1:2009 | Clinical investigation of medical devices for human subjects General requirements |
| 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 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 10451:2010 | Dentistry. Contents of technical file for dental implant systems |
| ISO 10451:2010 | Dentistry — Contents of technical file for dental implant systems |
| BS EN 1641:2004 | Dentistry. Medical devices for dentistry. Materials |
| EN ISO 10993-10:2013 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| EN ISO 21649:2009 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| EN ISO 7197:2009 | Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
| 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 1640:2009 | Dentistry - Medical devices for dentistry - Equipment |
| 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 ISO 14155-1:2009 | Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
| AAMI ISO 14155-1 : 2003 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
| BS ISO 11712:2009 | Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors |
| ANSI/AAMI/ISO 10993-10:2010(R2014) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
| ANSI Z80.30 : 2010 | OPHTHALMICS - TORIC INTRAOCULAR LENSES |
| 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 14708-4:2008(R2011) | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
| ANSI Z80.12 : 2007 : R2017 | OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES |
| 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 |
| UNI EN ISO 22794 : 2009 | DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| DIN EN ISO 10451:2010-11 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| 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 |
| CEN/TS 15277:2006 | Non-active surgical implants - Injectable implants |
| 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 (ISO 22442-3:2007) |
| EN 1060-4:2004 | 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 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN ISO 14155-1:2009 | Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
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