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BS ISO 11712:2023

BS ISO 11712:2023

$167.15

Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors

Published By Publication Date Number of Pages
BSI 2023 38
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PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 General requirements
4.1 General
4.2 Test methods
5 Materials
5.1 General
5.2 Biological safety testing
5.3 Guidance on materials specific to supralaryngeal airways and connectors
6 Design requirements
6.1 General
6.2 Ventilation positions of use
12 6.3 Size designation
6.4 Ventilatory openings
6.5 Safeguards against collapse of the ventilatory pathway
6.6 Seating mechanisms
13 6.7 Cuff inflation/deflation system
6.8 Internal volume
6.9 Maximum device size
14 6.10 Supralaryngeal airway connectors
6.11 Cleaning, disinfection and sterilization
7 Requirements for supralaryngeal airways and connectors supplied sterile
8 Packaging
9 Information supplied by the manufacturer
9.1 General
9.2 Marking on the supralaryngeal airway
15 9.3 Marking on supralaryngeal airway individual packs
9.4 Instructions for use
18 Annex A (informative) Rationale
24 Annex B (informative) Evaluation and documentation of the clinical performance in human subjects
26 Annex C (normative) Test methods to determine kink resistance
31 Annex D (informative) Hazard identification for risk management
35 Annex E (informative) Guidance on materials and design
37 Bibliography

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BS ISO 11712:2023
$167.15