IEC 60601-2-11:2013
IEC 60601-2-11:2013
Title | Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
Abstract | IEC 60601-2-11:2013 applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment. This particular standard of the 60601 series, establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It states tolerance limits beyond which interlocks must prevent, interrupt or terminate irradiation in order to avoid an unsafe condition. Type tests which are performed by the manufacturer, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. It does not attempt to define the optimum performance requirements for a gamma beam therapy equipment for use in radiotherapy. Its purpose is to identify those features of design which are regarded at the present time as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance at which it can be presumed that a fault condition applies, e.g. a component failure, and where an interlock then operates to prevent continued operation. This third edition cancels and replaces the second edition of IEC 60601-2-11 published in 1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards. |
Issue Date | 2013-01-16 |
Category | MED |
Included in IECEE System | 2014-01-07 |
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 |
---|---|---|---|---|
Canada | CAN/CSA-C22.2 NO. 60601-2-11:15 | 2015-05-13 | Download163 kb |
Laboratory Name | City | Country | Responsible National Certification Body |
---|---|---|---|
Toronto | Canada | ||
Kista | Sweden | ||
Shanghai | China | ||
Pleasanton, | United States of America | ||
München | Germany | ||
Fremont, | United States of America | ||
Melville | United States of America | ||
Northbrook, IL 60062 | United States of America |
Id | Name | City | Country |
---|---|---|---|
13336 | Toronto, Ontario | Canada | |
13371 | Kista | Sweden | |
13334 | BRUSSELS 1070 | Belgium | |
13346 | München | Germany | |
13423 | Northbrook | United States of America |
Id | Name | City | Country |
---|---|---|---|
13721 | BELLIS Testing and Certification of Home Appliances and Industrial Products JSC | Minsk | Belarus |