Name:
DANSK DS/EN ISO 7199 PDF
Published Date:
02/02/2017
Status:
[ Active ]
Publisher:
Dansk Standard
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.
| Edition : | 17# |
| File Size : | 1 file , 1.3 MB |
| Number of Pages : | 32 |
| Product Code(s) : | DS-031, DS-031 |
| Published : | 02/02/2017 |