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AAMI ISO 5362 : 2006

Current
Current

The latest, up-to-date edition.

ANAESTHETIC RESERVOIR BAGS
Available format(s)

Hardcopy , PDF

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
Current

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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