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Norma ASTM F639-09(2015) 1.3.2015 náhľad

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ASTM F639-09(2015)

Standard Specification for Polyethylene Plastics for Medical Applications

Automaticky preložený názov:

Štandardné špecifikácie pre polyetylénové plasty na lekárske účely

NORMA vydaná dňa 1.3.2015

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Dostupnosť	SKLADOM
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Informácie o norme:

Označenie normy: ASTM F639-09(2015)
Dátum vydania normy: 1.3.2015
Kód tovaru: NS-587590
Počet strán: 3
Približná hmotnosť: 9 g (0.02 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM

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Termoplasty

Anotácia textu normy ASTM F639-09(2015) :

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.

Keywords:
â€‡plastic surgical devices/applications, polyethylene (PE) plastics&mdash,surgical implant applications, polymers&mdash,surgical applications ,, ICS Number Code 11.100.99 (Other standards related to laboratory medicine), 83.080.20 (Thermoplastic materials)

Doplňujúce informácie

Significance and Use

X1.2 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 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, 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

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