ASTM F 2726 : 2008
Current
The latest, up-to-date edition.
Standard specification for fixation devices for tracheal tubes and other airway devices
Hardcopy , PDF
English
31-12-2010
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FOREWORD
INTRODUCTION
1. SCOPE
2. NORMATIVE REFERENCES
3. TERMS AND DEFINITIONS
4. GENERAL REQUIREMENTS
5. REQUIREMENTS
6. REQUIREMENTS FOR FIXATION DEVICES SUPPLIED
STERILE
7. CLEANING AND DISINFECTION OR STERILIZATION
8. MARKINGS
9. ACCOMPANYING DOCUMENTS
ANNEX A (INFORMATIVE) - RATIONALE
ANNEX B (INFORMATIVE) - GUIDELINES FOR
EVALUATING AND DOCUMENTING THE
CLINICAL PERFORMANCE OF FIXATION
DEVICES IN HUMAN SUBJECTS
ANNEX C (NORMATIVE) - TEST FOR SECURITY OF
ATTACHMENT
ANNEX D (NORMATIVE) - TEST METHOD TO DETERMINE
THE CHANGE IN PRESSURE DROP CAUSED BY
THE TUBE LOCKING MECHANISM
ANNEX E (INFORMATIVE) - HAZARD IDENTIFICATION FOR
RISK ASSESSMENT
ANNEX F (INFORMATIVE) - GUIDANCE ON MATERIALS AND
DESIGN
ANNEX G (INFORMATIVE) - BIBLIOGRAPHY
CONTAINED IN VOL. 13.02, 2015 Provides basic safety and essential performance requirements for fixation devices designed to be attached to the head, face, or mouth of the patient and equipped with a means to secure and stabilize a tracheal tube or other airway device in its intended position.
| Committee |
F 29
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Current
|
1.1 *This standard covers basic safety and essential performance requirements for fixation devices designed to be attached to the head, face, or mouth of the patient and equipped with a means to secure and stabilize a tracheal tube or other airway device in its intended position. Devices within the scope of this standard may be provided with a wide variety of patient attachment mechanisms and tube locking mechanisms. 1.2 *Devices intended to secure tracheostomy tubes are outside the scope of this standard. NOTE These requirements are addressed in ISO 5366-11 and 5366-32. 1.3 *Fixation devices intended to secure devices such as gastric tubes, feeding tubes and suction catheters are outside the scope of this standard. 1.4 Flammability of fixation devices, for example if used in the presence of certain flammable anesthetics, electrosurgical units, or lasers is a well-recognized hazard that is outside the scope of this standard. See Annex F for guidance.
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