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
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| ISO 14408:2016 | Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information |
| ASTM F 2560 : 2006 | Standard Specification for Supralaryngeal Airways and Connectors |
| ISO 5364:2016 | Anaesthetic and respiratory equipment — Oropharyngeal airways |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| ISO 5366-1:2000 | Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults |
| ISO 11990:2003 | Optics and optical instruments Lasers and laser-related equipment Determination of laser resistance of tracheal tube shafts |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ASTM D 2665 : 2014 : REDLINE | Standard Specification for Poly(Vinyl Chloride) (PVC) Plastic Drain, Waste, and Vent Pipe and Fittings |
| ISO 5366-3:2001 | Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes |
| ISO 11607:2003 | Packaging for terminally sterilized medical devices |
| ISO 5361:2016 | Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
| ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
| ISO 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.