ISO 80601-2-69:2014
ISO 80601-2-69:2014
| Title | Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| Abstract | ISO 80601-2-69:2014 specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment, including transit-operable use by a single patient in various environments including any private and public transportation as well as in commercial aircraft. ISO 80601-2-69:2014 is applicable to a transit-operable and non-transit-operable oxygen concentrator. It is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems. |
| Issue Date | 2014-05-12 |
| Category | MED |
| Included in IECEE System | 2015-04-16 |
| 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. 80601-2-69:16 | 2021-03-18 | Download53 kb |
Laboratory Name | City | Country | Responsible National Certification Body |
|---|---|---|---|
Wismar | Germany | ||
Boxborough, | United States of America | ||
Carlsbad, | United States of America | ||
Toronto | Canada | ||
Shanghai | China | ||
SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch | Guangzhou | China | |
Shenzhen | China | ||
Jiangsu | China | ||
Singapore 609937 | Singapore | ||
Suzhou | China |
Id | Name | City | Country |
|---|---|---|---|
13424 | IL 60005 | United States of America | |
13361 | Lysaker | Norway | |
13469 | Toronto, | Canada | |
13334 | BRUSSELS 1070 | Belgium | |
13342 | Helsinki | Finland | |
13345 | Nürnberg | Germany | |
13427 | Singapore 609937 | Singapore | |
13340 | Ballerup | Denmark |
Id | Name | City | Country |
|---|---|---|---|
13336 | Toronto, Ontario | Canada | |
13607 | Baltimore, | United States of America | |
13343 | Fontenay-Aux-Roses | France | |
13347 | Hartmannsdorf | Germany |