CSA ISO 11712:14 (R2019)

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.