IEC 60601-2-27:2011
IEC 60601-2-27:2011
Title | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
Abstract | IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. Electrocardiographic monitoring equipments intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes. The contents of the corrigendum of May 2012 have been included in this copy. |
Issue Date | 2011-03-30 |
Category | MED |
Included in IECEE System | 2011-08-16 |
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. 60601-2-27:11 | 2016-10-18 | 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 | |
94447 Plattling | Germany | ||
Seoul | Korea, Republic of | ||
Pointe Claire | Canada | ||
Toronto | Canada | ||
Arnhem | Netherlands | ||
DEKRA Testing and Certification (Shanghai) Ltd., Guangzhou branch | Guangzhou | China | |
Campanillas | Spain | ||
New Taipei City | Chinese Taipei | ||
Shanghai | China | ||
Aix en Provence | France | ||
Eurofins Electrical and Electronic Testing NA, Inc. (Irvine) | Irvine | United States of America | |
Reichenwalde b. Berlin | Germany | ||
Binyamina | Israel | ||
Modiin | Israel | ||
Gimpo-si | Korea, Republic of | ||
Milano | Italy | ||
Boxborough, | United States of America | ||
Kaufbeuren | Germany | ||
Duluth, | United States of America | ||
Lake Forest, | United States of America | ||
Menlo Park, | United States of America | ||
Fridley, MN | United States of America | ||
United Kingdom | |||
Shanghai | China | ||
Guangzhou, Guangdong | China | ||
Taipei City | Chinese Taipei | ||
Gyeonggi-do | Korea, Republic of | ||
Seoul 08389 | Korea, Republic of | ||
Fontenay-Aux-Roses | France | ||
Oak Creek | United States of America | ||
Carlsbad, | United States of America | ||
Gyeonggi-do | Korea, Republic of | ||
Gyeonggi-do 12735 | Korea, Republic of | ||
Tampere | Finland | ||
Helsinki | Finland | ||
Puchheim | Germany | ||
Madrid | Spain | ||
Shanghai | China | ||
SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch | Guangzhou | China | |
SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch | Shenzhen | China | |
Dongguan | China | ||
Bangalore – 560 100 | India | ||
Tel-Aviv | Israel | ||
Shenzhen | China | ||
Budapest | Hungary | ||
Yokohama, | Japan | ||
Nürnberg | Germany | ||
Taoyuan City 333 | Chinese Taipei | ||
Pleasanton, | United States of America | ||
San Diego | United States of America | ||
GORMLEY L0H 1G0 | Canada | ||
Jiangsu | China | ||
TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch | Guangzhou | China | |
Tokyo | Japan | ||
München | Germany | ||
Bengaluru | India | ||
Whitefield | India | ||
Ballerup | Denmark | ||
Warszawa | Poland | ||
Mie 516-0021 | Japan | ||
Uiwang-si | Korea, Republic of | ||
Melville | United States of America | ||
Mounds View | United States of America | ||
Northbrook, IL 60062 | United States of America | ||
Research Triangle Park | United States of America | ||
Guangzhou | China | ||
Kyiv | Ukraine | ||
Taipei City | Chinese Taipei | ||
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 | |
21201 | Binyamina | Israel | |
20269 | Modiin | Israel | |
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 | |
13361 | Lysaker | Norway | |
13334 | BRUSSELS 1070 | Belgium | |
13342 | Helsinki | Finland | |
13597 | Tel-Aviv | Israel | |
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 | |
13374 | Kyiv | Ukraine | |
13344 | Offenbach / Main | Germany |
Id | Name | City | Country |
---|---|---|---|
13721 | BELLIS Testing and Certification of Home Appliances and Industrial Products JSC | Minsk | Belarus |
13833 | Singapore | Singapore |