ISO 80601-2-61:2011
ISO 80601-2-61:2011
Title | Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
Abstract | ISO 80601-2-61:2011 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed. The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. ISO 80601-2-61:2011 can also be applied to pulse oximeter equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended solely for foetal use. ISO 80601-2-61:2011 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment. |
Issue Date | 2011-03-16 |
Category | MED |
Included in IECEE System | 2012-09-11 |
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. 80601-2-61:14 | 2015-04-16 | Download163 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 | |
94447 Plattling | Germany | ||
Seoul | Korea, Republic of | ||
Pointe Claire | Canada | ||
Arnhem | Netherlands | ||
Yongin-si | Korea, Republic of | ||
New Taipei City | Chinese Taipei | ||
Eurofins Electrical and Electronic Testing NA, Inc. (Irvine) | Irvine | United States of America | |
Reichenwalde b. Berlin | Germany | ||
Modiin | Israel | ||
Gimpo-si | Korea, Republic of | ||
Boxborough, | United States of America | ||
Duluth, | United States of America | ||
Lake Forest, | United States of America | ||
Plano, | United States of America | ||
Kista | Sweden | ||
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 | ||
Lysaker | Norway | ||
Shenzhen, Guangdong | China | ||
Puchheim | Germany | ||
Suwanee | United States of America | ||
Madrid | Spain | ||
Shanghai | China | ||
SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch | Guangzhou | China | |
Bangalore – 560 100 | India | ||
Tel-Aviv | Israel | ||
Shenzhen 518000 | China | ||
Budapest | Hungary | ||
Yokohama, | Japan | ||
Seoul, 07298 | Korea, Republic of | ||
Taoyuan City 333 | Chinese Taipei | ||
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 | ||
Singapore 609937 | Singapore | ||
München | Germany | ||
Bengaluru | India | ||
Whitefield | India | ||
Ballerup | Denmark | ||
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 | ||
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 | |
20269 | Modiin | Israel | |
13371 | Kista | Sweden | |
13365 | Singapore | Singapore | |
13424 | IL 60005 | United States of America | |
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 |
No information declared