AAMI ISO 5362 : 2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
04-09-2024
English
01-01-2006
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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Withdrawn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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