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  • ISO 14155-2:2003

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    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    Withdrawn date:  16-03-2019

    Language(s):  English

    Published date:  16-05-2003

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/DIS 14155-2. (05/2003)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    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 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 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)
    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
    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)

    Standards Referencing This Book - (Show below) - (Hide below)

    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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