NS EN 12022 : 1ED 1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
BLOOD GAS EXCHANGERS
01-11-2014
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
4.1 Biological characteristics
4.2 Physical characteristics
4.3 Performance characteristics
5 Compliance tests and measurements
5.1 General
5.2 Biological characteristics
5.3 Physical characteristics
5.4 Performance characteristics
6 Information supplied by the manufacturer
6.1 Information to be given on the blood-gas
exchanger
6.2 Information to be given on the packaging
6.3 Information to be given in the accompanying
documents
7 Packaging
Annex A (informative) Bibliography
Defines requirements for single-use, sterile, extracorporeal blood-gas exchangers intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans. Applicable to heat exchangers that are integral parts of blood-gas exchangers and to external equipment unique to the use of the device. Not applicable to liquid exchangers, separate heat exchangers, implanted blood-gas exchangers, extracorporeal circuits (blood-tubing), separate ancillary devices.
| DocumentType |
Standard
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Superseded
|
| Standards | Relationship |
| EN 12022:1999 | Identical |
| DIN EN 12022:1999-03 | Identical |
| UNE-EN 12022:1999 | Identical |
| BS EN 12022:1999 | Identical |
| NF EN 12022 : 1999 | Identical |
| I.S. EN 12022:1999 | Identical |
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