ASTM F754-00 - 10.5.2000
 
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