I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
08-26-2014
English
01-01-1999
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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 sterile, single-use, extracorporeal blood gas exchangers intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 12022:1999 | Identical |
| BS EN 12022:1999 | Identical |
| NS EN 12022 : 1ED 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 |
| 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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