1 Scope
This document, which is a Technical Report, 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.
NOTE The IEC 60601 series consists of three levels of standards: IEC 60601‑1, known as the general standard, several IEC 60601‑1‑X documents, known as the collateral standards, and a series of particular standards covering requirements for specific types of equipment (IEC 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 IEC 60601‑2‑66
itself. This document alone cannot be used to establish or assess compliance to IEC 60601‑2‑66.
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 aids and hearing aid systems.