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CSA ISO 11712:14 (R2019)

Current
Current

The latest, up-to-date edition.

Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Requirements
6 Requirements for supralaryngeal airways and connectors
  supplied sterile
7 Cleaning and disinfection or sterilization
8 Markings
9 Accompanying documents
Annex A (informative) - Rationale
Annex B (normative) - Evaluation and documentation of the
        clinical performance in human subjects
Annex C (normative) - Test methods to determine kink resistance
Annex D (informative) - Hazard identification for risk assessment
Annex E (informative) - Guidance on materials and design
Bibliography

CSA Preface This is the first edition of CAN/CSA-ISO 11712, Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11712 (first edition, 2009-05-15). At the time of publication, ISO 11712:2009 is available from ISO in English only. CSA Group will publish the French version when it becomes available from ISO. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope 1.1 This International Standard provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to open and seal the supralaryngeal area to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation. 1.2 This International Standard specifies the dimensions, basic properties and method of size designation of the available types of supralaryngeal airways. Airways devised for specialized applications are not specifically covered, although most may be classified by the sizing and dimensions (or other characteristics) required by this International Standard. 1.3 The following devices are outside the scope of this International Standard: nasal and oropharyngeal airways, anesthetic masks, oro- and naso-tracheal tubes, cricothyrotomy devices, dental appliances, tracheal stents, tracheal tubes, ventilating laryngoscopes, CPAP devices, esophageal obturators, bougies and devices that require surgical placement. 1.4 This International Standard requires dimensional disclosure so the operator will know which auxiliary instruments, such as tracheal tubes and bronchoscopes will be size-compatible. 1.5 Flammability of airways, for example if used with certain flammable anesthetics, electrosurgical units or lasers, is a well-recognized hazard that is outside the scope of this International Standard. See E.1.7.

CSA Preface This is the first edition of CAN/CSA-ISO 11712, Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11712 (first edition, 2009-05-15). At the time of publication, ISO 11712:2009 is available from ISO in English only. CSA Group will publish the French version when it becomes available from ISO. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope 1.1 This International Standard provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to open and seal the supralaryngeal area to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation. 1.2 This International Standard specifies the dimensions, basic properties and method of size designation of the available types of supralaryngeal airways. Airways devised for specialized applications are not specifically covered, although most may be classified by the sizing and dimensions (or other characteristics) required by this International Standard. 1.3 The following devices are outside the scope of this International Standard: nasal and oropharyngeal airways, anesthetic masks, oro- and naso-tracheal tubes, cricothyrotomy devices, dental appliances, tracheal stents, tracheal tubes, ventilating laryngoscopes, CPAP devices, esophageal obturators, bougies and devices that require surgical placement. 1.4 This International Standard requires dimensional disclosure so the operator will know which auxiliary instruments, such as tracheal tubes and bronchoscopes will be size-compatible. 1.5 Flammability of airways, for example if used with certain flammable anesthetics, electrosurgical units or lasers, is a well-recognized hazard that is outside the scope of this International Standard. See E.1.7.

DocumentType
Standard
ISBN
978-1-77139-846-6
Pages
47
PublisherName
Canadian Standards Association
Status
Current
Supersedes

Standards Relationship
ISO 11712:2009 Identical

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
ASTM F 2560 : 2006 Standard Specification for Supralaryngeal Airways and Connectors
ISO 5364:2016 Anaesthetic and respiratory equipment — Oropharyngeal airways
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
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 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO/TS 16628:2003 Tracheobronchial tubes Recommendations for size designation and labelling
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 11990:2003 Optics and optical instruments Lasers and laser-related equipment Determination of laser resistance of tracheal tube shafts
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
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 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO/TS 15843:2000 Sterilization of health care products Radiation sterilization Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
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
AAMI TIR20 : 2001 PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION

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