IEC/TR 62809-2013 pdf free.Summary of requirements and tests for products in the scope of IEC 60601-2-66.
This Technical Report provides an overview of the requirements and tests of IEC 60601-2-66 in combination with the applicable sections of lEG 60601-1, and the collateral standards of the lEG 60601 series.
NOTE The IEC 60601 series consists of three levels of standards: IEC 60601-1, known as the general standard, several lEG 60601-1-X documents, known as the collateral standards and a series of particular standards covering requirements for specific types of equipment (lEG 60601 -2-X).
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.
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.
The summary in Table 1 below does not preclude the user from reading the referenced standards in their entirety for a thorough knowledge of the basic safety of hearing instruments and hearing instrument systems.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
lEG 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
lEG 60601-2-66:2012, Medical electrical equipment — Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
3 Summary of requirements and tests
The reference column in Table 1 shows the clause number of IEC 60601 -2-66:2012 and, if applicable the reference to lEG 60601-1:2005, or other documents. References to the particular standard, IEC 60601 -2-66:2012 start with the number 201, while references to the general standard, lEG 60601-1:2005, start directly with the clause or subclause number.
Other documents will be referred to explicitly. Some detailed references, for example describing tools, are placed in the text instead of in the reference column.IEC/TR 62809 pdf download.