EN ISO 7199:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
25-01-2017
09-04-2020
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests and measurements to determine compliance
with this document
6 Information supplied by the manufacturer
7 Packaging
Bibliography
Annex ZA (informative) - Relationship between this
European standard and the essential requirements
of Directive 93/42/EEC [OJ L 169] aimed to be covered
ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.ISO 7199:2016 does not apply to- implanted oxygenators,- liquid oxygenators,- extracorporeal circuits (blood tubing),- separate heat exchangers,- separate ancillary devices, and- separate arterial line filter.
| Committee |
CEN/TC 205
|
| DevelopmentNote |
Supersedes EN 12022. (09/2014)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| NEN-EN-ISO 7199:2017 | Identical |
| ISO 7199:2016 | Identical |
| NF EN ISO 7199 : 2017 | Identical |
| NBN EN ISO 7199 : 2014 | Identical |
| NS EN ISO 7199 : 2017 | Identical |
| I.S. EN ISO 7199:2017 | Identical |
| PN EN ISO 7199 : 2017 | Identical |
| SS-EN ISO 7199 : 2017 | Identical |
| BS EN ISO 7199:2017 | Identical |
| DIN EN ISO 7199:2015-06 (Draft) | Identical |
| DIN EN ISO 7199:2017-05 | Identical |
| DS EN ISO 7199 : 2017 | Identical |
| UNE-EN ISO 7199:2017 | Identical |
| UNE-EN ISO 7199:2015 | Identical |