ASTM F639-98a

Standard Specification for Polyethylene Plastics for Medical Applications (Includes all amendments And changes 8/16/2017).

Automatically translated name:

Standard Specification for Polyethylene Plastics for Medical Applications

STANDARD published on 10.10.1998

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The information about the standard:

Designation standards: ASTM F639-98a
Note: WITHDRAWN
Publication date standards: 10.10.1998
SKU: NS-55979
The number of pages: 3
Approximate weight : 9 g (0.02 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F639-98a :

Keywords:
Plastic surgical devices/applications, Polyethylene (PE)-surgical implant applications, Polymers-surgical applications, polyethylene (PE) plastics for medical applications, spec

Additional information

1. Scope

1.1 This specification covers polyethylene plastics (as defined in Terminology D883) intended for use in medical device applications involving human tissue contact devices, short term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product.

1.2 This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, etc.

2. Referenced Documents

D790-17	Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D883-24	Standard Terminology Relating to Plastics
D1238-23a	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer (Includes all amendments and changes 12/6/2023).
D1505-18	Standard Test Method for Density of Plastics by the Density-Gradient Technique
D1898-68(1989)	Standard Practice for Sampling of Plastics (Withdrawn 1998)
D747-10	Standard Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam (Withdrawn 2019)
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
D671-93	Standard Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)
ISO 10993	Biological Evaluation of Medical Devices Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
D638-22	Standard Test Method for Tensile Properties of Plastics
E117-64 (1989)	Method for Spectrographic Analysis of Pig-Lead by the Point-To-Plane Technique (Withdrawn 1995)
D4976-12a(2020)	Standard Specification for Polyethylene Plastics Molding and Extrusion Materials (Includes all amendments and changes 11/17/2022).
D695-23	Standard Test Method for Compressive Properties of Rigid Plastics

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