UNI EN ISO 5367 : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
09-10-2023
15-01-2015
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Superseded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 | |
| Supersedes |
| 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 |
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