IEC 60601-1-11:2010
IEC 60601-1-11:2010
| Title | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| Abstract | IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication. The contents of the corrigendum of April 2011 have been included in this copy. |
| Issue Date | 2010-04-28 |
| Category | MED |
| Included in IECEE System | 2010-12-15 |
| Purchase | webstore |
| Test Report Form | |
| Testing Equipment List |
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 |
|---|---|---|---|---|
| us_nd_iec60601_1_11b | 2019-07-10 | Download69 kb |
Laboratory Name | City | Country | Responsible National Certification Body |
|---|---|---|---|
Bureau Veritas Consumer Products Services (Hong Kong) Limited, Taoyuan Branch | Taoyuan City, Taiwan | Chinese Taipei | |
Littleton 01460 | United States of America | ||
CCIC-CSA International Certification Co. Ltd. Shanghai Branch | Shanghai | China | |
Wismar | Germany | ||
94342 Strasskirchen | Germany | ||
Seoul | Korea, Republic of | ||
Pointe Claire | Canada | ||
Toronto | Canada | ||
Irvine | United States of America | ||
Arnhem | Netherlands | ||
Dresden | Germany | ||
Stuttgart | Germany | ||
Yongin-si | Korea, Republic of | ||
Regensdorf | Switzerland | ||
Chassieu | France | ||
182 00 Praha 8 – Troja | Czech Republic | ||
Eurofins Electric & Electronic Product Testing AG, Lab Fehraltorf | Fehraltorf | Switzerland | |
Eurofins Electrical and Electronic Testing NA, Inc. (Austin) | Austin | United States of America | |
Eurofins Electrical and Electronic Testing NA, Inc. (Baltimore) | Baltimore, MD 21230-3432 | United States of America | |
Reichenwalde b. Berlin | Germany | ||
Hørsholm 2970 | Denmark | ||
Binyamina | Israel | ||
Modiin | Israel | ||
Milano | Italy | ||
Boxborough, | United States of America | ||
Kaufbeuren | Germany | ||
Duluth, | United States of America | ||
Campoformido (UD) | Italy | ||
Lake Forest, | United States of America | ||
Menlo Park, | United States of America | ||
Fridley, MN | United States of America | ||
Plano, | United States of America | ||
Kista | Sweden | ||
United Kingdom | |||
Shanghai | China | ||
Guangzhou, Guangdong | China | ||
Japan Quality Assurance Organization, Kita-Kansai Testing Center - JQA Kita Kansai | Osaka | Japan | |
Japan Quality Assurance Organization, Safety & EMC Center - JQA Tokyo | Tokyo | Japan | |
Gyeonggi-do, 15809 | Korea, Republic of | ||
Kaufbeuren | Germany | ||
Gyeonggi-do | Korea, Republic of | ||
Fontenay-Aux-Roses | France | ||
Moirans | France | ||
TRAPPES | France | ||
Oak Creek | United States of America | ||
Ottawa | Canada | ||
Biassono (MB) | Italy | ||
Carlsbad, | United States of America | ||
Pfinztal | Germany | ||
Gyeonggi-do | Korea, Republic of | ||
Lysaker | Norway | ||
Shenzhen, Guangdong | China | ||
Gyeonggi-do 12735 | Korea, Republic of | ||
Helsinki | Finland | ||
Puchheim | Germany | ||
Gunpo-si | Korea, Republic of | ||
Suwanee | United States of America | ||
Taiwan 248 | Chinese Taipei | ||
Shanghai | China | ||
SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch | Guangzhou | China | |
Ljubljana | Slovenia | ||
Hartmannsdorf | Germany | ||
Genas | France | ||
Dongguan | China | ||
Gyeonggi-do | Korea, Republic of | ||
Bangalore – 560 100 | India | ||
Taoyuan City | Chinese Taipei | ||
Tel-Aviv | Israel | ||
Shanghai | China | ||
Nanshan District | China | ||
Budapest | Hungary | ||
Pogliano Milanese | Italy | ||
Yokohama, | Japan | ||
Berlin | Germany | ||
Nürnberg | Germany | ||
Taoyuan City 333 | Chinese Taipei | ||
Pleasanton, | United States of America | ||
Peabody | United States of America | ||
New Brighton | United States of America | ||
San Diego | United States of America | ||
Tampa, | United States of America | ||
Taiwan | Chinese Taipei | ||
GORMLEY | Canada | ||
TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch | Guangzhou | China | |
Tokyo 160-0023 | Japan | ||
Singapore 609937 | Singapore | ||
Hannover | Germany | ||
München | Germany | ||
Ballerup | Denmark | ||
Singapore | Singapore | ||
Mie 516-0021 | Japan | ||
Uiwang-si | Korea, Republic of | ||
Fremont, | United States of America | ||
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 | ||
Suzhou | China | ||
Taipei City | Chinese Taipei | ||
Saarbrücken | Germany |
Id | Name | City | Country |
|---|---|---|---|
13864 | COURBEVOIE | France | |
13336 | Toronto, Ontario | Canada | |
13360 | Arnhem | Netherlands | |
26080 | Beaucouzé | France | |
13339 | Praha 8 - Troja 171 02 | Czech Republic | |
13372 | Fehraltorf | Switzerland | |
13607 | Baltimore, | United States of America | |
13348 | Reichenwalde b. Berlin | Germany | |
21077 | Broendby | Denmark | |
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 | |
13353 | Tokyo | Japan | |
13358 | Gunpo-si,Gyeonggi-do, 15809 | Korea, Republic of | |
13749 | NL - 7327 AC Apeldoorn | Netherlands | |
13359 | Gyeonggi-do | Korea, Republic of | |
13343 | Fontenay-Aux-Roses | France | |
13641 | Paris Cedex 15 | France | |
13361 | Lysaker | Norway | |
13334 | BRUSSELS 1070 | Belgium | |
13342 | Helsinki | Finland | |
13597 | Tel-Aviv | Israel | |
13367 | Ljubljana | Slovenia | |
13347 | Hartmannsdorf | Germany | |
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 |
No information declared