IEC 60601-2-28:2017
IEC 60601-2-28:2017
Title | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
Abstract | IEC 60601-2-28:2017 applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to me equipment, this is interpreted as X-ray tube assemblies in this particular standard. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred to as the general standard. Apart from the changes related to the amendment of IEC 60601-1, changes related to technical improvements are also included. |
Issue Date | 2017-06-16 |
Category | MED |
Included in IECEE System | 2017-08-14 |
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 | CSA C22.2 No. 60601-2-28:18 | 2022-09-14 | Download53 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 | ||
Yongin-si | Korea, Republic of | ||
Gyeonggi-do | Korea, Republic of | ||
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 | ||
Shanghai | China | ||
Guangzhou, Guangdong | China | ||
Gyeonggi-do | Korea, Republic of | ||
Seoul 08389 | Korea, Republic of | ||
Fontenay-Aux-Roses | France | ||
Gyeonggi-do | Korea, Republic of | ||
Gyeonggi-do 12735 | Korea, Republic of | ||
Tampere | Finland | ||
Helsinki | Finland | ||
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 | ||
Shanghai | China | ||
Shenzhen | China | ||
Budapest | Hungary | ||
Yokohama, | Japan | ||
Nürnberg | Germany | ||
Boxborough, MA 01719 | United States of America | ||
Pleasanton, | United States of America | ||
München | Germany | ||
Ballerup | Denmark | ||
Mie 516-0021 | Japan | ||
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 | |
13348 | Reichenwalde b. Berlin | Germany | |
13351 | Milano | Italy | |
13371 | Kista | Sweden | |
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 | |
13361 | Lysaker | Norway | |
13334 | BRUSSELS 1070 | Belgium | |
13342 | Helsinki | Finland | |
13349 | Budapest | Hungary | |
13354 | Yokohama | Japan | |
13345 | Nürnberg | Germany | |
13346 | München | Germany | |
13340 | Ballerup | Denmark | |
13423 | Northbrook | United States of America | |
13344 | Offenbach / Main | Germany |
Id | Name | City | Country |
---|---|---|---|
13360 | Arnhem | Netherlands |