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BS EN ISO 5361:2012:2014 Edition

BS EN ISO 5361:2012:2014 Edition

$198.66

Anaesthetic and respiratory equipment. Tracheal tubes and connectors

Published By Publication Date Number of Pages
BSI 2014 56
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This International Standard provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning or monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard.

Tracheobronchial (endobronchial) tubes, tracheostomy tubes and supralaryngeal airways are excluded from the scope of this International Standard.

Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are outside the scope of this International Standard.

NOTE ISO/TR 11991, ISO 11990-1, ISO 11990-2, and ISO 14408 cover this[1][2][3][4].

PDF Catalog

PDF Pages PDF Title
9 Foreword
10 Introduction
12 1 *Scope
2 Normative references
13 3 Terms and definitions
16 4 *General requirements for tracheal tubes and tracheal tube connectors
4.1 Risk assessment
17 4.2 Safety
5 Specific requirements for tracheal tubes and tracheal tube connectors
5.1 Size designation
5.2 Dimensions
25 5.3 *Materials
26 5.4 Tracheal tube bevel
5.5 *Tracheal tube cuffs
27 5.6 Inflating system for cuffs
5.7 Curvature of the tube
29 5.8 *Radiopaque marker
5.9 *Kink resistance
30 6 Additional requirement for tracheal tubes with a Murphy eye
6.1 Size of the Murphy eye
6.2 Location of the Murphy eye
6.3 Resistance to kinking or collapse of the Murphy eye
6.4 Surface characteristics of the Murphy eye
31 7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile
7.1 Sterility assurance
7.2 Packaging for tracheal tubes and tracheal tube connectors supplied sterile
8 Marking
8.1 Use of symbols
8.2 Tracheal tubes
32 8.3 Marking on the tracheal tube individual pack or any insert
34 8.4 Marking on tracheal tube connectors
35 AnnexĀ A
(informative)

Rationale

39 AnnexĀ B
(normative)

Determination of cuff diameter

40 AnnexĀ C
(normative)

Test method for cuffed tube collapse

43 AnnexĀ D
(normative)

*Test method for cuff herniation

45 AnnexĀ E
(informative)

Guidance on design of tracheal tube connectors

46 AnnexĀ F
(informative)

Hazard identification for risk assessment
AnnexĀ F
(informative)

Hazard identification for risk assessment

49 AnnexĀ G
(normative)

*Test method for tracheal seal
AnnexĀ G
(normative)

*Test method for tracheal seal

52 AnnexĀ H
(normative)

Test method to determine kink resistance
AnnexĀ H
(normative)

Test method to determine kink resistance

54 Bibliography
Bibliography

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BS EN ISO 5361:2012
$198.66