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  • BS EN 80601-2-58:2015

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Medical electrical equipment Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  14-09-2019

    Language(s):  English

    Published date:  30-06-2015

    Publisher:  British Standards Institution

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    IEC 80601-2-58:2014 applies 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. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard.

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    Committee CH/62/4
    Development Note Supersedes 07/30157980 DC. (03/2009) 2009 + A11 2011 Edition remains active & will be withdrawn on 29/05/2018. Supersedes 13/30271473 DC. (06/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Withdrawn
    Superseded By
    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
    EN 60825-1:2014/AC:2017-06 SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014)
    EN 60065:2014/AC:2017-01 AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016)
    EN ISO 15004-2:2007 Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2007)
    ISO 15752:2010 Ophthalmic instruments Endoilluminators Fundamental requirements and test methods for optical radiation safety
    EN 60950-1:2006/A2:2013 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60950-1:2005/A2:2013, MODIFIED)
    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
    EN 60601-2-22:2013 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    EN ISO 15752:2010 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety (ISO 15752:2010)
    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
    EN 60601-1-2:2015 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
    EN 61847:1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
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