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  • ANSI/AAMI/IEC 80601-2-58:2014

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  10-09-2014

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI adoption of Amendment
    1 to IEC 80601-2-58:2014
    Foreword
    Introduction to the Amendment
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing
           of ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and
           documents
    201.8 Protection against electrical hazards from
           me equipment
    201.9 Protection against mechanical hazards of
           ME EQUIPMENT and ME SYSTEMS
    201.10 Protection against unwanted and excessive
           radiation hazards
    201.11 Protection against excessive temperatures
           and other hazards
    201.12 Accuracy of controls and instruments and
           protection against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions for
           ME EQUIPMENT
    201.14 Programmable electrical medical systems (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT and
           ME SYSTEMS
    202 Electromagnetic disturbances - Requirements and tests
    Annexes
    Annex C (informative) - Guide to marking and labelling
            requirements for ME EQUIPMENT and ME SYSTEMS
    Annex D (informative) - Symbols on marking (See Clause 7)
    Annex AA (informative) - Particular guidance and rationale
    Bibliography
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.

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

    Committee 62
    Document Type Standard
    Product Note NEW CHILD AMD 1 2016 IS NOW ADDED
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

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

    IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 15752:2010 Ophthalmic instruments Endoilluminators Fundamental requirements and test methods for optical radiation safety
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    IEC 61847:1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
    IEC 60601-2-22:2007+AMD1:2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    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
    IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    ISO 15004-2:2007 Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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