AAMI ISO 5367 : 2015
Withdrawn
ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
English
12-29-2015
04-17-2024
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption
of ISO 5367:2014
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Specific requirements
6 Prevention of electrostatic charges
7 Requirements for breathing sets and
breathing tubes supplied sterile
8 Marking
Annex A (informative) - Rationale
Annex B (informative) - Hazard
identification for risk
assessment
Annex C (normative) - Test for security of
attachment of plain end to conical
connector
Annex D (normative) - Test for security
of attachment of adaptor to
breathing tube
Annex E (normative) - Test for leakage
Annex F (normative) - Measurement of
resistance to flow
Annex G (normative) - Test for increase
in flow resistance with bending
Annex H (normative) - Test for compliance
Bibliography
Describes basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers.
| Committee |
ISO/TC 121/SC 2
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-606-1
|
| Pages |
45
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ISO 5367:2014 | Identical |
| ISO 80601-2-13:2011 | Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 80601-2-12:2011 | Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| ISO 5362:2006 | Anaesthetic reservoir bags |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems |
| ISO 23328-2:2002 | Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 9360-1:2000 | Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml |
| ISO 14971:2007 | Medical devices — Application of risk management to 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 |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
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