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DIN EN ISO 7199/A1:2018-09
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) - Amendment 1: Connectors (ISO 7199:2016/DAM 1:2018); German and English version EN ISO 7199:2017/prA1:2018More info
This document 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. This document also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device. This document does not apply to: implanted oxygenators; liquid oxygenators; extracorporeal circuits (blood tubing); separate heat exchangers; separate ancillary devices.
| Author | DIN |
|---|---|
| Editor | DIN |
| Document type | Amendment draft |
| Format | File |
| expiration_de_validite | 2018-10-17 |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics |
| Number of pages | 30 |
| Cross references | EN ISO 7199/prA1 (2018-05), IDT |
| Set | MYSTD-20STD |
| Year | 2018 |
| Document history | |
| Country | Germany |
| Keyword | DIN EN ISO 7199;EN ISO 7199;EN ISO 7199/A1;7199 |