EN 12022:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Blood gas exchangers
01-08-2014
20-01-1999
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
This European Standard specifies requirements for sterile, single-use, extracorporeal blood gas exchangers intended for supply of oxygen to, and removal of carbon dioxid from, the blood of humans. This European Standard also applies to heat exchangers that are integral parts of blood gas exchangers and to external equipment unique to the use of the device. This European Standard does not apply to: - implanted blood gas exchangers; - liquid exchangers; - extracorporeal circuits (blod tubing); - separate heat exchangers; - separate ancillary devices.
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| BS EN 12022:1999 | Identical |
| NS EN 12022 : 1ED 1999 | Identical |
| I.S. EN 12022:1999 | Identical |
| NBN EN 12022 : 1999 | Identical |
| SN EN 12022 : 1999 | Identical |
| NF EN 12022 : 1999 | Identical |
| UNE-EN 12022:1999 | Identical |
| UNI EN 12022 : 1999 | Identical |
| NEN EN 12022 : 1999 | Identical |
| PN EN 12022 : 2002 | Identical |
| DIN EN 12022:1999-03 | Identical |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| EN ISO 10993-11:2009 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
| EN 46001 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| EN ISO 10993-7 : 2008 COR 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009) |
| EN 1283:1996 | Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| EN 46002 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN 1707:1996 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
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