IEC 60601-2-66:2012
IEC 60601-2-66:2012
Title | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
Abstract | IEC 60601-2-66:2012 International Standard applies to the basic safety of hearing instruments and hearing instrument systems. Hazards inherent in the intended physiological function of hearing instruments or hearing instrument systems within the scope of this standard are not covered by specific requirements in this standard except in 201.7.9.2 and 201.9.6. Accessories to hearing instruments in the home healthcare environment (e.g. remote control units, audio streamers, battery chargers, power supplies) are covered by the most applicable standard, IEC 60065, IEC 60950-1 or other applicable IEC safety standards. Accessories connected to a hearing instrument may form a hearing instrument system. Only the hearing instrument and its detachable parts are subject to all applicable clauses of this particular standard. The remaining components of the hearing instrument system are subject to requirements of this particular standard that result from their connection to the hearing instrument system. This standard does not apply to: |
Issue Date | 2012-10-02 |
Category | MED |
Included in IECEE System | 2012-10-25 |
Purchase | webstore |
Test Report Form | |
Testing Equipment List | No information declared |
DISCLAIMER: National differences
The National differences and Group differences, National Deviations and Special National conditions (SNC), are based solely on information provided to the Secretariat by the IECEE Member Bodies and/or NCBs and other sources. The IEC/IECEE is not responsible for, nor will it take any position related to, the accuracy or validity of the information provided. To verify the current status of this type of information, we recommend contacting the Member Body (MB) or National Certification Body (NCB) of the relevant country.
Group Differences are applicable for CENELEC member countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Group/Country | Reference | Last Modified | Differences | TRF Addendum |
---|---|---|---|---|
| CAN/CSA-C22.2 No. 60601-2-66:15 | 2016-12-14 | Download113 kb |
Laboratory Name | City | Country | Responsible National Certification Body |
---|---|---|---|
Pointe Claire | Canada | ||
Arnhem | Netherlands | ||
Reichenwalde b. Berlin | Germany | ||
Hørsholm 2970 | Denmark | ||
Menlo Park, | United States of America | ||
Gyeonggi-do | Korea, Republic of | ||
Gyeonggi-do | Korea, Republic of | ||
Lysaker | Norway | ||
Shanghai | China | ||
Singapore 609937 | Singapore | ||
Offenbach / Main | Germany | ||
Saarbrücken | Germany |
Id | Name | City | Country |
---|---|---|---|
13336 | Toronto, Ontario | Canada | |
13360 | Arnhem | Netherlands | |
13348 | Reichenwalde b. Berlin | Germany | |
21077 | Broendby | Denmark | |
13424 | IL 60005 | United States of America | |
13359 | Gyeonggi-do | Korea, Republic of | |
13361 | Lysaker | Norway | |
13334 | BRUSSELS 1070 | Belgium | |
13345 | Nürnberg | Germany | |
13427 | Singapore 609937 | Singapore | |
13344 | Offenbach / Main | Germany |
Id | Name | City | Country |
---|---|---|---|
13607 | Baltimore, | United States of America | |
13371 | Kista | Sweden | |
13423 | Northbrook | United States of America |