Date : 10-10-20 16:30
LVD test standard IEC 60601-1 Ed.3
 Name : CE Manager
Hit : 427  
Before 1 June 2012 Test Report newer version Ed.3 than the 1995 must be submitted.
(Current 60601-1 standard  are removed on 1 June 2011)

- With IEC 60601-1 3rd Ed. All medical electrical equipment must be tested again!
- Before June 1,2012 the new standard must be satisfied.
- Design changes may be needed

Newly revised 3rd edition of IEC 60601-1 on scale is bigger than 2nd edition, including software, electromagnetic, functional safety, usability, alarm and all information related to electrical safety and essential performance of medical devices including.
If you want to sell the existing product proved by 2nd edition even after 06/01/2012,  the 3rd edition is necessary. Because of the result, applying ime of the standard must be put foward to reduce re-examinations.

※ 'revised standard [IEC60601-1 (3 edition)]' s main information: conformance to specifications, as well as 'risk management' and 'Evaluation of Software Validation', etc. in addition, mandatory
International Electrotechnical Commission (IEC), the standard existing in '05 (2nd edition) was revised, the United States, Europe, Canada and other countries will apply 'revised standards' in 2012.