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AAMI ISO 5362 : 2006

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

ANAESTHETIC RESERVOIR BAGS
Available format(s)

Hardcopy , PDF

Withdrawn date

04-09-2024

Language(s)

English

Published date

01-01-2006

1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Prevention of electrostatic charges
6 Requirements for bags supplied by the
  manufacture
Annex A (informative) - Test for leakage
Annex B (normative) - Determination of capacity
Annex C (normative) - Test for security of
        attachment of plain neck to 22 mm
        male conical connector
Annex D (normative) - Test for security of
        attachment of adaptor of assembled
        neck to bag
Annex E (normative) - Test for resistance to
        pressure required to distend the bag
        (pressure/volume)
Annex F (informative) - Test for resistance to
        pressure required to distend the bag using
        air (pressure/volume)
Annex G (informative) - Recommendations for materials
Bibliography

Defines requirements for antistatic and non-antistatic reservoir bags for use with for use with anaesthetic apparatus or lung-ventilator breathing systems.

DevelopmentNote
Issued by AAMI in January 2015. (01/2015)
DocumentType
Standard
ISBN
1-57020-541-8
Pages
22
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Withdrawn

Standards Relationship
ISO 5362:2006 Identical

EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
EN 980:2008 Symbols for use in the labelling of medical devices

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