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AAMI ISO 5361 : 2012

Current
Current

The latest, up-to-date edition.

ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-01-2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for tracheal tubes and
  tracheal tube connectors
5 Specific requirements for tracheal tubes and
  tracheal tube connectors
6 Additional requirement for tracheal tubes with
  a Murphy eye
7 Requirements for tracheal tubes with tracheal
  tube connectors supplied sterile
8 Marking
Annex A (informative) - Rationale
Annex B (normative) - Determination of cuff diameter
Annex C (normative) - Test method for cuffed tube collapse
Annex D (normative) - Test method for cuff herniation
Annex E (informative) - Guidance on design of tracheal
        tube connectors
Annex F (informative) - Hazard identifications for risk
        assessment
Annex G (normative) - Test method for tracheal seal
Annex H (normative) - Test method to determine kink
        resistance
Bibliography

Gives essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors.

Committee
TC 121
DevelopmentNote
Issued by AAMI in January 2015. (01/2015)
DocumentType
Standard
ISBN
1570205280
Pages
51
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current

Standards Relationship
ISO 5361:2016 Identical

ISO 11990-1:2011 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft
ISO 14408:2016 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11990-2:2010 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs
ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
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 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ANSI Z79.16 : 1983 CUFFED OROTRACHEAL AND NASOTRACHEAL TUBES FOR PROLONGED USE,
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
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
ASTM F 1242 : 1996 : EDT 1 Standard Specification for Cuffed and Uncuffed Tracheal Tubes (Withdrawn 2002)
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 980:2008 Symbols for use in the labelling of medical devices
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use

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