EN 12022 : 1999

Name: EN 12022 : 1999
Brand: CEN

Superseded

View Superseded by

BLOOD GAS EXCHANGERS

Superseded date

01-08-2014

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

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.

Committee	TC 205
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 7199:2017

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 ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
EN 554 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT