• IEC TR 62809:2013

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Summary of requirements and tests to products in the scope of IEC 60601-2-66

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  31-12-2021

    Language(s):  English

    Published date:  29-01-2013

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Summary of requirements and tests
    Bibliography

    Abstract - (Show below) - (Hide below)

    IEC/TR 62809:2013(E) provides an overview of the requirements and tests of IEC 60601-2-66 in combination with the applicable sections of IEC 60601-1, and the collateral standards of the IEC 60601 series. It is intended to assist various groups involved in the product lifecycles process - like designers and suppliers - to get an overview of the basic requirements without studying all involved standard documents in detail. The table includes not all but just the more common requirements and tests. During the preparation of IEC 60601-2-66, members of the involved technical committee and working group voiced concerns about the complexity of the document and its structure as part of the IEC 60601 series. There was also concern that groups in the hearing instrument community would have problems to understand and apply the standard and that this could be an issue with its acceptability. In order to have a broad consensus for the new standard it was agreed that the standard should be supported by this Technical Report, which should enable members of the community and the industry to have a basic understanding of the requirements of the standard, without the need to study the complete standard document and the documents that are referenced in it. It is crucial to understand that the summary in this document cannot serve as an input for a product requirement specification or as a test plan without consulting the standard document itself. This Technical Report alone cannot be used to establish or assess compliance to the standard. Keywords: hearing instruments, hearing aids, hearing

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

    Committee TC 29
    Development Note Stability date: 2018. (09/2017)
    Document Type Technical Report
    Publisher International Electrotechnical Committee
    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
    IEC 60118-7:2005 Electroacoustics - Hearing aids - Part 7: Measurement of the performance characteristics of hearing aids for production, supply and delivery quality assurance purposes
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60118-13:2016 Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)
    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
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    IEC 60601-2-66:2015 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
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