Name: UNI EN ISO 5367 : 2015
Brand: UNI

UNI EN ISO 5367 : 2015

Superseded

View Superseded by

ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS

Superseded date

09-10-2023

Published date

15-01-2015

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

This International Standard specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers.

Committee	CT 44
DevelopmentNote	Supersedes UNI EN 12342. (01/2015)
DocumentType	Standard
ProductNote	This standard is identical to EN ISO 5367 : 2014
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 5367:2023
Supersedes	UNI EN 12342 : 2009

Standards	Relationship
EN ISO 5367:2014	Identical
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 10414-2:2011	Petroleum and natural gas industries Field testing of drilling fluids Part 2: Oil-based fluids
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
ISO 15403:2000	Natural gas Designation of the quality of natural gas for use as a compressed fuel for vehicles
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 6142:2001	Gas analysis Preparation of calibration gas mixtures Gravimetric method
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO/IEC Guide 21-1:2005	Regional or national adoption of International Standards and other International Deliverables — Part 1: Adoption of International Standards
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