AAMI ISO 5362 : 2006
Withdrawn
ANAESTHETIC RESERVOIR BAGS
English
01-01-2006
04-09-2024
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Withdrawn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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