Standard
[WITHDRAWN]
ISO 11712:2009-05
Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
German title
Anästhesie- und Beatmungsgeräte - Über dem Kehlkopf liegende Luftwege und Verbindungsstücke
Publication date
2009-05
Original language
English
Pages
28
Publication date
2009-05
Original language
English
Pages
28
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Content
Content (en)
Foreword
Introduction
Scope
Normative references
Terms and definitions
General requirements
*Requirements
Show subsection Close subsection Supralaryngeal airways
Show subsection Close subsection *Size designation
Materials
*Ventilatory opening
*Safeguards against collapse of the ventilatory pathway
*Sealing mechanism
*Internal volume
Maximum instrument size
Supralaryngeal airway connectors
Requirements for supralaryngeal airways and connectors supplied sterile
Show subsection Close subsection Sterility assurance
Packaging for supralaryngeal airways and connectors supplied sterile
Cleaning and disinfection or sterilization
Markings
Show subsection Close subsection Use of symbols
Marking of the supralaryngeal airway
Marking on the supralaryngeal airway individual pack
Accompanying documents
Rationale (informative)
Show subsection Close subsection Evaluation and documentation of the clinical performance in human subjects (normative)
Show subsection Close subsection General
Methods, testing on patients
Test methods to determine kink resistance (normative)
Show subsection Close subsection Principle
Apparatus
Procedure
Show subsection Close subsection Securing and conditioning the supralaryngeal airway to the minimum radius of curvature apparatus
Measurement of pressure drop
Expression of results
Hazard identification for risk assessment (informative)
Show subsection Close subsection Potential hazards associated with the use of supralaryngeal airways
Potential device hazards
Mitigations
Guidance on materials and design (informative)
Show subsection Close subsection Supralaryngeal airway materials
Connectors
Other design considerations
Bibliography
Cooperation at DIN
Please get in touch with the relevant contact person at DIN if you have problems understanding the content of the standard or need advice on how to apply it.
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