IEC 62353:2007
IEC 62353:2007
Title | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
Abstract | Applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems, or parts of such equipment or systems, which comply with IEC 60601-1, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such me equipment or me systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the me equipment or me system is designed. This standard contains: - "general requirements", which contain clauses of general concern, and - "particular requirements", further clauses handling special types of me equipment or me systems and applying in connection with the "General requirements". This standard is also applicable to tests after repair. The testing shall be defined according to the extent of work performed and applicable guidance from the manufacturer. |
Issue Date | 2007-05-15 |
Category | MED |
Included in IECEE System | 2007-11-30 |
Purchase | webstore |
Test Report Form | No information declared |
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.
No information declared
Laboratory Name | City | Country | Responsible National Certification Body |
---|---|---|---|
Budapest | Hungary |
Id | Name | City | Country |
---|---|---|---|
13349 | Budapest | Hungary |
Id | Name | City | Country |
---|---|---|---|
13371 | Kista | Sweden | |
13424 | IL 60005 | United States of America |