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  • 13/30271473 DC : 0

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    BS EN 80601-2-58 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-06-2015

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    FOREWORD
    INTRODUCTION
    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
    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 compatibility - Requirements and tests
    Annexes
    Annex C (informative) - Guide to marking and labelling
            requirements for ME EQUIPMENT and ME SYSTEMS
    Annex AA (informative) - Particular guidance and rationale
    Bibliography
    Index of defined terms

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

    Comment Closes On
    Committee CH/62/4
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    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
    2001/104/EC : 2001 COR 1 2002 DIRECTIVE 2001/104/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 7 DECEMBER 2001 AMENDING COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES (TEXT WITH EEA RELEVANCE)
    2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
    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
    2000/70/EC : 2000 DIRECTIVE 2000/70/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 16 NOVEMBER 2000 AMENDING COUNCIL DIRECTIVE 93/42/EC AS REGARDS MEDICAL DEVICES INCORPORATING STABLE DERIVATES OF HUMAN BLOOD OR HUMAN PLASMA
    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
    ISO 15004-2:2007 Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection
    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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