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Norma ASTM F624-09(2015)e1 1.3.2015 náhled

Doplňující informace

ASTM F624-09(2015)e1

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications (Includes all amendments and changes 12/27/2016).

Automaticky přeložený název:

Standardní Příručka pro hodnocení z termoplastického polyuretanu, pevných látek a řešení pro biomedicínské aplikace

NORMA vydána dne 1.3.2015

Jazyk
Provedení	PDF - okamžité stažení - 1 290.90 Kč Tištěné - 1 290.90 Kč
Dostupnost	SKLADEM
Cena	1 290.90 Kč bez DPH
1 290.90 Kč

Informace o normě:

Označení normy: ASTM F624-09(2015)e1
Datum vydání normy: 1.3.2015
Kód zboží: NS-587589
Počet stran: 4
Přibližná hmotnost: 12 g (0.03 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

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Kategorie - podobné normy:

Termoplasty

Anotace textu normy ASTM F624-09(2015)e1 :

Keywords:
plastic surgical devices/applications, polymers-surgical applications, polyurethane-medical applications ,, ICS Number Code 11.100.99 (Other standards related to laboratory medicine), 83.080.20 (Thermoplastic materials)

Doplňující informace

Significance and Use

4.1 This guide is intended to aid device fabricators in the selection of proper commercially available polyurethane solids and solutions for their application.

4.2 The polyurethanes covered by this guide may be thermoformed or solution cast into biomedical devices for use as surgical aids or for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data.

1. Scope

1.1 This guide covers the evaluation of thermoplastic polyurethanes in both solid and solution form for biomedical applications. The polymers have been reacted to completion and require no further chemical processing.

1.2 The tests and methods listed in this guide may be referenced in specifications containing minimum required values and tolerances for specific end-use products.

1.3 Standard tests for biocompatibility are included to aid in the assessment of safe utilization in biomedical applications. Compliance with these criteria shall not be construed as an endorsement of implantability. Since many compositions, formulations, and forms of thermoplastic polyurethanes in solid and solution forms are within this material class, the formulator or fabricator must evaluate the biocompatibility of the specific composition or form in the intended use and after completion of all manufacturing processes including sterilization.

1.4 Purchase specifications may be prepared by agreement between the buyer and seller by selection of appropriate tests and methods from those listed applicable to the specific biomedical end use.

1.5 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

D149-20	Standard Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies
D3418-21	Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
D1238-23a	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer (Includes all amendments and changes 12/6/2023).
D1242-95a	Standard Test Methods for Resistance of Plastic Materials to Abrasion (Withdrawn 2004)
D1434-23	Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
D1638-74	Methods of Testing Urethane Foam Isocyanate Raw Materials (Withdrawn 1989)
D2124-99e1	Standard Test Method for Analysis of Components in Poly(Vinyl Chloride) Compounds Using an Infrared Spectrophotometric Technique
D2240-15(2021)	Standard Test Method for Rubber Property—Durometer Hardness
D2857-22	Standard Practice for Dilute Solution Viscosity of Polymers
D2990-17	Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
E96/E96M-23	Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
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.
D1544-04(2023)	Standard Test Method for Color of Transparent Liquids (Gardner Color Scale)
D257-14(2021)e1	Standard Test Methods for DC Resistance or Conductance of Insulating Materials (Includes all amendments and changes 5/6/2021).
D395-18	Standard Test Methods for Rubber Property´Compression Set
D412-16(2021)	Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
D570-22	Standard Test Method for Water Absorption of Plastics
D150-22	Standard Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation
D575-91(2018)	Standard Test Methods for Rubber Properties in Compression
D671-93	Standard Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)
D790-17	Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D3137-81(2018)	Standard Test Method for Rubber Property´Hydrolytic Stability
D792-20	Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement