IEC 60601-2-54:2009
IEC 60601-2-54:2009
Title | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
Abstract | IEC 60601-2-54:2009 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54. The contents of the corrigenda of March 2010 and June 2011 have been included in this copy. |
Issue Date | 2009-06-29 |
Category | MED |
Included in IECEE System | 2009-07-27 |
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 60601-2-54:11 | 2017-01-20 | Download111 kb |
Laboratory Name | City | Country | Responsible National Certification Body |
---|---|---|---|
Suwon-si | Korea, Republic of | ||
CCIC-CSA International Certification Co. Ltd. Shanghai Branch | Shanghai | China | |
Seoul | Korea, Republic of | ||
Pointe Claire | Canada | ||
Toronto | Canada | ||
Arnhem | Netherlands | ||
Yongin-si | Korea, Republic of | ||
Eurofins Electrical and Electronic Testing NA, Inc. (Baltimore) | Baltimore, MD 21230-3432 | United States of America | |
Gyeonggi-do | Korea, Republic of | ||
Gimpo-si | Korea, Republic of | ||
Milano | Italy | ||
Boxborough, | United States of America | ||
Tokyo | Japan | ||
Fridley, MN | United States of America | ||
Kista | Sweden | ||
United Kingdom | |||
Shanghai | China | ||
Guangzhou, Guangdong | China | ||
Gyeonggi-do | Korea, Republic of | ||
Seoul 08389 | Korea, Republic of | ||
Fontenay-Aux-Roses | France | ||
TRAPPES | France | ||
Gyeonggi-do | Korea, Republic of | ||
Gyeonggi-do 12735 | Korea, Republic of | ||
Puchheim | Germany | ||
Gunpo-si | Korea, Republic of | ||
Madrid | Spain | ||
Shanghai | China | ||
SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch | Guangzhou | China | |
SGS-CSTC Standards Technical Services Co., Ltd. Wuhan Branch | Wuhan | China | |
Gyeonggi-do | Korea, Republic of | ||
Bangalore – 560 100 | India | ||
Shanghai | China | ||
Shenzhen | China | ||
Budapest | Hungary | ||
Yokohama, | Japan | ||
Nürnberg | Germany | ||
Boxborough, MA 01719 | United States of America | ||
Jiangsu | China | ||
TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch | Guangzhou | China | |
München | Germany | ||
Ballerup | Denmark | ||
Uiwang-si | Korea, Republic of | ||
Fremont, | United States of America | ||
Melville | United States of America | ||
Northbrook, IL 60062 | United States of America | ||
Suzhou | China | ||
Offenbach / Main | Germany |
Id | Name | City | Country |
---|---|---|---|
13336 | Toronto, Ontario | Canada | |
13360 | Arnhem | Netherlands | |
13607 | Baltimore, | United States of America | |
13348 | Reichenwalde b. Berlin | Germany | |
13351 | Milano | Italy | |
13371 | Kista | Sweden | |
13375 | Surrey | United Kingdom | |
13365 | Singapore | Singapore | |
13424 | IL 60005 | United States of America | |
13358 | Gunpo-si,Gyeonggi-do, 15809 | Korea, Republic of | |
13359 | Gyeonggi-do | Korea, Republic of | |
13356 | Gyeongsangnam-do | Korea, Republic of | |
13343 | Fontenay-Aux-Roses | France | |
13641 | Paris Cedex 15 | France | |
13361 | Lysaker | Norway | |
13334 | BRUSSELS 1070 | Belgium | |
13342 | Helsinki | Finland | |
13349 | Budapest | Hungary | |
13354 | Yokohama | Japan | |
13345 | Nürnberg | Germany | |
13427 | Singapore 609937 | Singapore | |
13346 | München | Germany | |
13340 | Ballerup | Denmark | |
13423 | Northbrook | United States of America | |
13344 | Offenbach / Main | Germany |
Id | Name | City | Country |
---|---|---|---|
20269 | Modiin | Israel |