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BS EN 12022:1999

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

12-31-2014

Language(s)

English

Published date

06-15-1999

Publisher

British Standards Institution

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.

This European Standard specifies 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.

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 (blood tubing);

  • separate heat exchangers;

  • separate ancillary devices.

Committee
CH/150/2
DevelopmentNote
Supersedes 95/562596 DC (08/2004)
DocumentType
Standard
Pages
12
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
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
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 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
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
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
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 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

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