What is PD IEC TR 62809- Requirements and tests to products about?
PD IEC TR 62809 is a safety standard on the summary of requirements and tests to products in the scope of IEC 60601-2-66.
PD IEC TR 62809, 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.
PD IEC TR 62809 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.
Note 1: 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).
Note 2: The summary in PD IEC TR 62809 cannot serve as an input for a product requirement specification or as a test plan without consulting IEC 60601-2-66 itself. PD IEC TR 62809 alone cannot be used to establish or assess compliance to IEC 60601-2-66.
Note 3: The summary in Table 1 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.
Who is PD IEC TR 62809- Requirements and tests to products for?
PD IEC TR 62809 on hearing aids systems is relevant to:
- Audiologists
- Manufacturers of hearing aids
Why should you use PD IEC TR 62809- Requirements and tests to products?
IEC 60601-2-66 was published to address the specific requirements for the safety of hearing aids, and it is entitled “Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems”.
IEC 60601-2-66 was also published because IEC 60601-1 is a general standard intended to address a wide range of medical electrical equipment – including large-scale facilities such as MRI machines, for example – and thus has large sections that are not relevant to low-voltage, low-power, subminiature hearing aids. PD IEC TR 62809 includes specific references to the applicable requirements within IEC 60601-1, and it is suggested that hearing aid designers and manufacturers along with test and regulatory organizations read this Technical Report as an overview of IEC 60601-2-66.
Overall, PD IEC TR 62809 is useful as it provides guidance on the hearing aids and hearing aids systems.
What’s changed since the last update?
PD IEC TR 62809:2019 supersedes PD IEC/TR 62809:2013, which is withdrawn.
PD IEC TR 62809:2019 replaces the first edition published in 2013. PD IEC TR 62809:2019 constitutes a technical revision.
PD IEC TR 62809:2019 includes the following significant technical changes with respect to the previous edition:
- Introduction of the term FITTED OSPL90 (FITTED MAXIMUM OUTPUT SOUND PRESSURE LEVEL) (201.3.206 of IEC 60601-2-66:2019)
- The allowable maximum output sound pressure level is now based on FITTED MAXIMUM OUTPUT SOUND PRESSURE LEVEL (201.9.6 of IEC 60601-2-66:2019)
- ESSENTIAL PERFORMANCE is based on risk analysis (201.4.3)