IEC 60601-1-6:2010
IEC 60601-1-6:2010
| Title | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| Abstract | IEC 60601-1-6:2010 specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. |
| Issue Date | 2010-01-27 |
| Category | MED |
| Included in IECEE System | 2010-02-08 |
| 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 |
|---|---|---|---|---|
| CAN/CSA-C22.2 No. 60601-1-6:11 | 2023-06-01 | Download70 kb |
Laboratory Name | City | Country | Responsible National Certification Body |
|---|---|---|---|
Suwon-si | Korea, Republic of | ||
Loughborough | United Kingdom | ||
Littleton 01460 | United States of America | ||
CCIC-CSA International Certification Co. Ltd. Shanghai Branch | Shanghai | China | |
Wismar | Germany | ||
94447 Plattling | Germany | ||
Tokyo | Japan | ||
Seoul | Korea, Republic of | ||
Pointe Claire | Canada | ||
Toronto | Canada | ||
Irvine | United States of America | ||
Shenzhen, Guangdong | China | ||
Matsusaka-shi | Japan | ||
Arnhem | Netherlands | ||
Shanghai 200436 | China | ||
DEKRA Testing and Certification (Shanghai) Ltd., Guangzhou branch | Guangzhou | China | |
Suzhou | China | ||
Dresden | Germany | ||
Stuttgart | Germany | ||
Campanillas | Spain | ||
Yongin-si | Korea, Republic of | ||
Calenzano (FI) | Italy | ||
CH-8105 Regensdorf | Switzerland | ||
Chassieu | France | ||
Troja, 182 00 Praha 8 | Czech Republic | ||
Hull | United Kingdom | ||
West Yorkshire, WF10 5PY | United Kingdom | ||
New Taipei City | Chinese Taipei | ||
Eurofins Electric & Electronic Product Testing AG, Lab Fehraltorf | Fehraltorf | Switzerland | |
Shanghai | China | ||
Aix en Provence | France | ||
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 | |
Eurofins Electrical and Electronic Testing NA, Inc. (Irvine) | Irvine | United States of America | |
Eurofins Electrical and Electronic Testing NA, Inc. (Union City) | Union City | United States of America | |
Gyeonggi-do | Korea, Republic of | ||
Reichenwalde b. Berlin | Germany | ||
Hørsholm 2970 | Denmark | ||
Gyeonggi-Do | Korea, Republic of | ||
Binyamina | Israel | ||
Modiin | Israel | ||
Gimpo-si | Korea, Republic of | ||
Milano | Italy | ||
Boxborough, | United States of America | ||
Kaufbeuren | Germany | ||
Duluth, | United States of America | ||
Campoformido (UD) | Italy | ||
Tokyo | Japan | ||
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 | ||
Taipei City | Chinese Taipei | ||
Gyeonggi-do | Korea, Republic of | ||
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 | ||
Seoul 08389 | Korea, Republic of | ||
Fontenay-Aux-Roses | France | ||
Moirans | France | ||
TRAPPES | France | ||
Oak Creek | United States of America | ||
Ottawa | Canada | ||
Biassono (MB) | Italy | ||
Neihu, Taipei | Chinese Taipei | ||
Carlsbad, | United States of America | ||
Pfinztal | Germany | ||
Gyeonggi-do | Korea, Republic of | ||
Lysaker | Norway | ||
Shenzhen, Guangdong | China | ||
Gyeonggi-do 12735 | Korea, Republic of | ||
New Taipei City 24450, Taiwan | Chinese Taipei | ||
Rancho Cucamonga | United States of America | ||
Toronto | Canada | ||
Brussels | Belgium | ||
Tampere | Finland | ||
Helsinki | Finland | ||
Puchheim | Germany | ||
Yokohama | Japan | ||
Gunpo-si | Korea, Republic of | ||
Suwanee | United States of America | ||
Taiwan 248 | Chinese Taipei | ||
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 | |
SGS-CSTC Standards Technical Services Co., Ltd. Wuhan Branch | Wuhan | China | |
Ljubljana | Slovenia | ||
Hartmannsdorf | Germany | ||
Genas | France | ||
Dongguan | China | ||
Gyeonggi-do | Korea, Republic of | ||
Hsin-Tien | Chinese Taipei | ||
Bangalore – 560 100 | India | ||
Taoyuan City | Chinese Taipei | ||
Tel-Aviv | Israel | ||
Shanghai | China | ||
Shenzhen | China | ||
Budapest | Hungary | ||
Pogliano Milanese | Italy | ||
Yokohama, | Japan | ||
Seoul, 07298 | Korea, Republic of | ||
Berlin | Germany | ||
Nürnberg | Germany | ||
Taoyuan City 333 | Chinese Taipei | ||
Boxborough, MA 01719 | United States of America | ||
Pleasanton, | 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 L0H 1G0 | Canada | ||
Jiangsu | China | ||
TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch | Guangzhou | China | |
Tokyo | Japan | ||
Singapore 609937 | Singapore | ||
Hannover | Germany | ||
München | Germany | ||
Bengaluru | India | ||
Ballerup | Denmark | ||
Neu-Isenburg (Zeppelinheim) | Germany | ||
20061 Carugate (MI) | Italy | ||
Warszawa | Poland | ||
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 | ||
Basingstoke | United Kingdom | ||
Suzhou | China | ||
Guangzhou | China | ||
Kyiv | Ukraine | ||
Taipei City | Chinese Taipei | ||
Offenbach / Main | Germany | ||
New Taipei City | Chinese Taipei | ||
Falconara Marittima (AN) | Italy | ||
Saarbrücken | Germany |
Id | Name | City | Country |
|---|---|---|---|
13864 | COURBEVOIE | France | |
13422 | Milton Keynes | United Kingdom | |
13336 | Toronto, Ontario | Canada | |
13833 | Singapore | Singapore | |
27722 | Mie 515-1104 | Japan | |
13360 | Arnhem | Netherlands | |
26080 | Beaucouzé | France | |
13339 | Troja, 182 00 Praha 8 | Czech Republic | |
13478 | Skelmersdale | United Kingdom | |
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 | |
13356 | Gyeongsangnam-do | Korea, Republic of | |
13343 | Fontenay-Aux-Roses | France | |
13641 | Paris Cedex 15 | France | |
13361 | Lysaker | Norway | |
13469 | Toronto, | Canada | |
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 | |
13374 | Kyiv | Ukraine | |
13344 | Offenbach / Main | Germany |
Id | Name | City | Country |
|---|---|---|---|
22917 | Getafe | Spain | |
13372 | Fehraltorf | Switzerland | |
25918 | Tai Po, | China |