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  • 14/30290166 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-03-2016

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Essential principles of safety and performance
      of medical devices
    5 Use of standards and guides in support of the
      essential principles
    6 Essential principles and references to relevant
      standards and guides
    Annex A (informative) - Rationale and guidance
    Annex B (normative) - Table relating essential principles
            to standards
    Annex C (informative) - Website listings of other standards
            suitable for the medical device sector and for
            assessment purposes
    Annex D (informative) - Reference to the Essential Principles
            by International Standards
    Bibliography

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

    Comment Closes On
    Committee CH/210
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO/TS 13004:2013 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    IEC TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
    IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
    ISO/TR 24971:2013 Medical devices Guidance on the application of ISO 14971
    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    IEC PAS 61910-1:2007 Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy
    ASTM F 2212 : 2011 : REDLINE Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
    IEC 60522:1999 Determination of the permanent filtration of X-ray tube assemblies
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    ISO/TS 19218-1:2011 Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes
    ISO 21969:2009 High-pressure flexible connections for use with medical gas systems
    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
    ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO 9584:1993 Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants
    ISO 690-2:1997 Information and documentation Bibliographic references Part 2: Electronic documents or parts thereof
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    ISO 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    ISO 9583:1993 Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants
    IEC 60580:2000 Medical electrical equipment - Dose area product meters
    ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 15985:2014 Plastics — Determination of the ultimate anaerobic biodegradation under high-solids anaerobic-digestion conditions — Method by analysis of released biogas
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    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
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 6474:1994 Implants for surgery Ceramic materials based on high purity alumina
    IEC 62471:2006 Photobiological safety of lamps and lamp systems
    ISO 7153-1:2016 Surgical instruments Materials Part 1: Metals
    IEC 60627:2013 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
    ISO 14969:1999 Quality systems Medical devices Guidance on the application of ISO 13485 and ISO 13488
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
    ISO 8828:2014 Implants for surgery Guidance on care and handling of orthopaedic implants
    ISO 13402:1995 Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    AAMI TIR49 : 2013 DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS
    ISO 13782:1996 Implants for surgery Metallic materials Unalloyed tantalum for surgical implant applications
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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