IEC TR 62809 pdf free download

IEC TR 62809 pdf free download.Summary of requirements and tests to products in the scope of IEC 60601-2-66.
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.
lEO 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-2-66:2019, Medical electrical equipment— Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
4 Summary of requirements and tests
The reference column in Table 1 shows the clause number of IEC 60601-2-66:2019 and, if applicable, the reference to IEC 60601-1:2005, or other documents. References to the particular standard IEC 60601-2-66:2019 start with the number 201, while references to the general standard, IEC 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.
Requirements:
ACCESSORIES TO HEARING AIDS (e.g. remote-control units, audio streamers, battery chargers, power supplies) need to have documented proof of compliance to IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. They form a HEARING AID SYSTEM when connected to the HEARING AID. Wherever this connection has an influence on the compliance to the requirements of IEC 60601-2-66, the HEARING AID has to pass the requirements while being connected to the ACCESSORY. If this connection results in additional requirements to the ACCESSORY, these requirements shall be fulfilled beyond the applicable IEC standards.
Programming interfaces or ACCESSORIES in a clinical application are covered by IEC 60601 (all parts).
For HEARING AIDS that are supplied by an external power source: If a particular separate power supply is specified, then the relevant tests are performed with the HEARING AIDS connected to it. If a generic separate power supply is specified, then the specification in the ACCOMPANYING DOCUMENTS is inspected.
Tests:
Inspection of ACCESSORY documentation, test configuration
TYPE TESTS are performed on a representative sample of the item being tested. If multiple products are under consideration, which have a similar mechanical and electrical architecture, then an engineering analysis by the MANUFACTURER may justify a single representative sample for a family of products.
Testing conditions shall consider not just NORMAL USE but also reasonably foreseeable misuse. Misuse and faults shall be the subject and results of the RISK ANALYSIS. The instructions for use shall be considered in testing conditions.
The equipment is tested under the least favorable working conditions.
Requirements:
A RISK MANAGEMENT complying with ISO 14971 shall be performed.
Where IEC 60601-2-66 specifies requirements addressing particular RISKS, alternative means of addressing these RISKS are acceptable provided that the MANUFACTURER can justify that the RESIDUAL RISKS are the same or lower.
Tests:
Inspection of the RISK MANAGEMENT FILE.
Requirements:
After a careful consideration of the clauses within this document, it was decided that they all deal with BASIC SAFETY as defined in the general standard. Manufacturers have the ability to identify functions of HEARING AIDS which are considered ESSENTIAL PERFORMANCE in accordance with their RISK MANAGEMENT PROCESS.
Requirements:
The MANUFACTURER shall state the EXPECTED SERVICE LIFE of the HEARING AID in the RISK MANAGEMENT FILE.
Tests:
Inspection of the RISK MANAGEMENT FILE.
Requirements:
Components the failure of which could result in a HAZARDOUS SITUATION shall be used in accordance with their specified ratings. The reliability of components that are used as MEANS OF PROTECTION shall be assessed. They shall comply with the applicable safety requirements of a relevant IEC or ISO standard (options see 4.8).IEC TR 62809 pdf download.