Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Requirements
  5.1 Supralaryngeal airways
      5.1.1 Size designation
      5.1.2 Materials
      5.1.3 Ventilatory opening
      5.1.4 Safeguards against collapse of the ventilatory
            pathway
      5.1.5 Sealing mechanism
      5.1.6 Internal volume
      5.1.7 Maximum instrument size
  5.2 Supralaryngeal airway connectors
6 Requirements for supralaryngeal airways and connectors
  supplied sterile
  6.1 Sterility assurance
  6.2 Packaging for supralaryngeal airways and connectors
      supplied sterile
7 Cleaning and disinfection or sterilization
8 Markings
  8.1 Use of symbols
  8.2 Marking of the supralaryngeal airway
  8.3 Marking on the supralaryngeal airway individual pack
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

Abstract

Describes the essential requirements for the design of supralaryngeal airways and connectors.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 121
Supersedes	ISO/DIS 11712 : 60.00 (2009)