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BS ISO 11712:2023 – TC

BS ISO 11712:2023 – TC

$217.84

Tracked Changes. Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors

Published By Publication Date Number of Pages
BSI 2023 89
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PDF Catalog

PDF Pages PDF Title
52 National foreword
56 Foreword
57 Introduction
59 1 Scope
2 Normative references
3 Terms and definitions
61 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
62 6.3 Size designation
6.4 Ventilatory openings
6.5 Safeguards against collapse of the ventilatory pathway
6.6 Seating mechanisms
63 6.7 Cuff inflation/deflation system
6.8 Internal volume
6.9 Maximum device size
64 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
65 9.3 Marking on supralaryngeal airway individual packs
9.4 Instructions for use
68 Annex A (informative) Rationale
74 Annex B (informative) Evaluation and documentation of the clinical performance in human subjects
76 Annex C (normative) Test methods to determine kink resistance
81 Annex D (informative) Hazard identification for risk management
85 Annex E (informative) Guidance on materials and design
87 Bibliography

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BS ISO 11712:2023 - TC
$217.84