ASTM F754-00

Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes

STANDARD published on 10.5.2000

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The information about the standard:

Designation standards: ASTM F754-00
Note: WITHDRAWN
Publication date standards: 10.5.2000
SKU: NS-56348
The number of pages: 4
Approximate weight : 12 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F754-00 :

Keywords:

Fluoropolymers-PTFE (polytetrafluoroethylene), Implants, Plastic surgical devices/applications, Polymers-surgical applications, implantable polytetrafluoroethylene (PTFE) polymer (in sheet/tube/rod, shapes), spec, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

1. Scope

1.1 This specification describes the performance of polytetrafluoroethylene (PTFE) fabricated in sheet, tube, and rod shapes which may be used for surgical implants. PTFE is a member of the generic class of perfluorocarbon (containing only the elements fluorine and carbon) polymers.

1.2 Perfluorocarbon high polymers are solids exhibiting extraordinary thermal and chemical stability. They do not require stabilizing additives of any kind.

1.3 The biological response to PTFE in soft tissue and bone has been well characterized by a history of clinical use and animal studies (1-9).

1.4 This specification does not apply to specific surgical implants. Such implants would be subject to appropriate end-use performance standards.

2. Referenced Documents

D1710-15(2021)	Standard Specification for Extruded Polytetrafluoroethylene (PTFE) Rod, Heavy Walled Tubing and Basic Shapes
D3294-22	Standard Specification for Polytetrafluoroethylene (PTFE) Resin Molded Sheet and Molded Basic Shapes
21 CFR 820	Quality System Regulation
ANSI/ISO/ASQ Q9000	Quality Management Systems--Fundamentals and Vocabulary
ANSI/ISO/ASQ Q9001	Quality Management Systems--Requirements
ISO 10993	Biological Evaluation of Medical Devices
D4894-19	Standard Specification for Polytetrafluoroethylene (PTFE) Granular Molding and Ram Extrusion Materials
E1994-09(2023)	Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
AAMI STBK9–1	Sterilization--Part 1: Sterilization in Health Care Facilities
AAMI STBK9–2	Sterilization--Part 2: Sterilization Equipment
AAMI STBK9–3	Sterilization--Part 3: Industrial Process Control

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