PD IEC/TR 62809:2013 - Summary of requirements and tests for products in the scope of IEC 60601-2-66

PD IEC/TR 62809:2013

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

Status : Superseded, Withdrawn   Published : October 2013 Replaced By : PD IEC TR 62809:2019

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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




Standard NumberPD IEC/TR 62809:2013
TitleSummary of requirements and tests for products in the scope of IEC 60601-2-66
StatusSuperseded, Withdrawn
Publication Date31 October 2013
Withdrawn Date30 October 2019
Normative References(Required to achieve compliance to this standard)IEC 60601-2-66:2012, IEC 60601-1:2005
Informative References(Provided for Information)ISO 10993, IEC 60601-1-11:2010, IEC 60601, IEC 60601-1-1:2000, ISO 14971:2000, IEC 60950-1:2005, IEC 60118-13:2011, IEC 60118-7:2005, IEC 60529:1989, IEC 60601-1-6, IEC 60065:2001, IEC 60825-1:2007, IEC 62304
Replaced ByPD IEC TR 62809:2019
International RelationshipsIEC TR 62809:2013
DescriptorsElectronic equipment and components, Acoustic equipment, Medical equipment, Electrical equipment, Electrical safety, Safety measures, Electrical medical equipment, Acoustic measurement, Hearing aids, Performance, Acoustoelectric devices, Safety engineering
ICS11.180.15
17.140.50
CommitteeEPL/29
ISBN978 0 580 79711 8
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size1.067 MB
Price£130.00


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