IEC 60601-1-6:2004
IEC 60601-1-6:2004
| Title | Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability |
| Abstract | Medical practice is increasingly using medical electrical equipment for observation and treatment of patients. use errors caused by inadequate medical electrical equipment usability have become an increasing cause for concern. The usability engineering process is intended to achieve reasonable usability, which in turn is intended to minimise use errors and to minimise use associated risks. Some, but not all, forms of incorrect use are amenable to control by the manufacturer. The usability engineering process is part of the process of risk control. This Collateral Standard describes a usability engineering process, and provides guidance on how to implement and execute the process to provide medical electrical equipment safety. It addresses normal use and use errors but excludes abnormal use. |
| Issue Date | 2004-06-24 |
| Category | MED |
| Included in IECEE System | 2007-10-01 |
| 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.
No information declared
Laboratory Name | City | Country | Responsible National Certification Body |
|---|---|---|---|
94342 Strasskirchen | Germany | ||
Seoul | Korea, Republic of | ||
Pointe Claire | Canada | ||
Toronto | Canada | ||
Arnhem | Netherlands | ||
Eurofins Electric & Electronic Product Testing AG, Lab Fehraltorf | Fehraltorf | Switzerland | |
Reichenwalde b. Berlin | Germany | ||
Modiin | Israel | ||
Milano | Italy | ||
Boxborough, | United States of America | ||
Kaufbeuren | Germany | ||
Duluth, | United States of America | ||
Menlo Park, | United States of America | ||
Kista | Sweden | ||
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 | |
Fontenay-Aux-Roses | France | ||
TRAPPES | France | ||
Oak Creek | United States of America | ||
Toronto | Canada | ||
Tampere | Finland | ||
Helsinki | Finland | ||
Puchheim | Germany | ||
Suwanee | United States of America | ||
Ljubljana | Slovenia | ||
Tel-Aviv | Israel | ||
Budapest | Hungary | ||
Yokohama, | Japan | ||
Nürnberg | Germany | ||
Taoyuan City 333 | Chinese Taipei | ||
Peabody | United States of America | ||
New Brighton | United States of America | ||
San Diego | United States of America | ||
GORMLEY | Canada | ||
Jiangsu | China | ||
Tokyo 160-0023 | Japan | ||
Singapore 609937 | Singapore | ||
Hannover | Germany | ||
München | Germany | ||
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 | ||
Offenbach / Main | Germany |
Id | Name | City | Country |
|---|---|---|---|
13336 | Toronto, Ontario | Canada | |
13360 | Arnhem | Netherlands | |
13372 | Fehraltorf | Switzerland | |
13348 | Reichenwalde b. Berlin | Germany | |
20269 | Modiin | Israel | |
13351 | Milano | Italy | |
13371 | Kista | Sweden | |
13365 | Singapore | Singapore | |
13424 | IL 60005 | United States of America | |
13353 | Tokyo | Japan | |
13343 | Fontenay-Aux-Roses | France | |
13641 | Paris Cedex 15 | France | |
13469 | Toronto, | Canada | |
13334 | BRUSSELS 1070 | Belgium | |
13342 | Helsinki | Finland | |
13597 | Tel-Aviv | Israel | |
13367 | Ljubljana | Slovenia | |
13349 | Budapest | Hungary | |
13354 | Yokohama | Japan | |
13345 | Nürnberg | Germany | |
13427 | Singapore 609937 | Singapore | |
13346 | München | Germany | |
13423 | Northbrook | United States of America | |
13344 | Offenbach / Main | Germany |
Id | Name | City | Country |
|---|---|---|---|
26080 | Beaucouzé | France | |
13339 | Praha 8 - Troja 171 02 | Czech Republic | |
13358 | Gunpo-si,Gyeonggi-do, 15809 | Korea, Republic of | |
13359 | Gyeonggi-do | Korea, Republic of | |
13356 | Seoul | Korea, Republic of | |
13340 | Ballerup | Denmark | |
13364 | Warsaw | Poland |