This specification covers the properties for polyethylene plastics for use in medical device applications involving human tissue contact devices, short term indwellings, and fluid transfer devices. Biocompatibility tests must be conducted on the final products as the biocompatibility of these materials as a class has not been established. Plyethylene plastics should consist of basic polymers with ethylene as essentially the sole monomer. The compound may contain optional adjuvant substances required in polymer production or fabrication. The final compound should yield a consistent absorption spectrum characteristic of the established formulation. The polyethylene plastics should be tested using the specified physical test procedures for density, melt flow, tensile properties, compressive properties, stiffness, flexural fatigue, and other flexural properties.

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

Significance and Use

Significance

X1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metal’s concentration in extracts is based on the surface area of the plastic extracted from which the total amount of metal deliverable to the patient may be estimated.

1. Scope

1.1 This specification covers polyethylene plastics (as defined in Terminology D 883) 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, and so forth.

1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D638 Test Method for Tensile Properties of Plastics

D671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force

D695 Test Method for Compressive Properties of Rigid Plastics

D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam

D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

D883 Terminology Relating to Plastics

D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer

D1505 Test Method for Density of Plastics by the Density-Gradient Technique

D1898 Practice for Sampling of Plastics

D4976 Specification for Polyethylene Plastics Molding and Extrusion Materials

E117 Method for Spectrographic Analysis of Pig Lead by the Point-to-Plane Technique

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

ISO Standard

Keywords

plastic surgical devices/applications; polyethylene (PE) plastics—surgical implant applications; polymers—surgical applications; Plastic surgical devices/applications--specifications; Polyethylene (PE) surgical implant applications--specifications; Polymers (surgical applications)--specifications;

ICS Code

ICS Number Code 11.120.01 (Pharmaceutics in general); 83.080.20 (Thermoplastic materials)

Citing ASTM Standards

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