IEC 80601-2-78:2019
IEC 80601-2-78:2019
| Title | Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
| Abstract | IEC 80601-2-78:2019 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER. |
| Issue Date | 2019-07-09 |
| Category | MED |
| Included in IECEE System | 2020-04-28 |
| 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. 80601-2-78:19 | 2020-05-29 | Download52 kb |
Laboratory Name | City | Country | Responsible National Certification Body |
|---|---|---|---|
Littleton 01460 | United States of America | ||
CCIC-CSA International Certification Co. Ltd. Shanghai Branch | Shanghai | China | |
Seoul | Korea, Republic of | ||
DEKRA Testing and Certification (Shanghai) Ltd., Guangzhou branch | Guangzhou | China | |
CH-8105 Regensdorf | Switzerland | ||
Boxborough, | United States of America | ||
Kaufbeuren | Germany | ||
Plano, | United States of America | ||
Seoul 08389 | Korea, Republic of | ||
Shanghai | China | ||
SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch | Guangzhou | China | |
SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch | Shenzhen | China | |
Ljubljana | Slovenia | ||
Budapest | Hungary | ||
Pogliano Milanese | Italy | ||
Singapore 609937 | Singapore | ||
Hannover | Germany |
Id | Name | City | Country |
|---|---|---|---|
13336 | Toronto, Ontario | Canada | |
13360 | Arnhem | Netherlands | |
13348 | Reichenwalde b. Berlin | Germany | |
13371 | Kista | Sweden | |
13424 | IL 60005 | United States of America | |
13356 | Gyeongsangnam-do | Korea, Republic of | |
13343 | Fontenay-Aux-Roses | France | |
13334 | BRUSSELS 1070 | Belgium | |
13342 | Helsinki | Finland | |
13367 | Ljubljana | Slovenia | |
13349 | Budapest | Hungary | |
13345 | Nürnberg | Germany | |
13427 | Singapore 609937 | Singapore | |
13346 | München | Germany |
Id | Name | City | Country |
|---|---|---|---|
13372 | Fehraltorf | Switzerland | |
13607 | Baltimore, | United States of America | |
13641 | Paris Cedex 15 | France | |
13361 | Lysaker | Norway |