Name: AAMI ISO 5367 : 2015
Brand: AAMI

AAMI ISO 5367 : 2015

Withdrawn

ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS

Withdrawn date

17-04-2024

Published date

29-12-2015

Publisher

Association for the Advancement of Medical Instrumentation

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
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Status	Withdrawn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