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BS EN ISO 5361:2016

BS EN ISO 5361:2016

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Anaesthetic and respiratory equipment. Tracheal tubes and connectors

Available format(s)

Hardcopy , PDF

Superseded date

02-07-2023

Language(s)

English

Published date

10-31-2016

Publisher

British Standards Institution

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 identification
        for risk assessment
Annex G (normative) - Test method for tracheal
        seal
Annex H (normative) - Test method to determine
        kink resistance
Bibliography
Annex ZA (informative) - Relationship between this
        European Standard and the Essential
        Requirements of EU Directive 93/42/EEC

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

Committee
CH/121/5
DevelopmentNote
Supersedes BS EN 1782. (04/2014) Supersedes 14/30281859 DC. (10/2016)
DocumentType
Standard
Pages
56
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 5361:2016 Identical
EN 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 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
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
EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
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
EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use

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Hardcopy - English
PDF - English
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