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Doplňujúce informácie

ASTM F2565-13

Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

Automaticky preložený názov:

Štandardné príručka pre značne Ožarovanie-sieťovaná Ultra-High polyetylén zvarený Formy na chirurgický implantát aplikácie

NORMA vydaná dňa 15.7.2013

Jazyk
Prevedenie	PDF - okamžité stiahnutie - 61.80 € Tlačené - 61.80 €
Dostupnosť	SKLADOM
Cena	61.80 € bez DPH
61.80 €

Informácie o norme:

Označenie normy: ASTM F2565-13
Poznámka: NEPLATNÁ
Dátum vydania normy: 15.7.2013
Kód tovaru: NS-54144
Počet strán: 4
Približná hmotnosť: 12 g (0.03 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM

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Kategórie - podobné normy:

Implantáty pro chirurgii, protetiku a ortotiku
Termosety

Anotácia textu normy ASTM F2565-13 :

Keywords:
fabricated forms, powdered form, ultra-high molecular weight polyethylene, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics),83.080.10 (Thermosetting materials)

Doplňujúce informácie

1. Scope

1.1 This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Test Method F648.

1.2 This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods.

1.3 This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.

1.4 The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials.

1.5 The following precautionary caveat pertains only to the test method portion, Section 5, of this guide. 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

F2183-02	Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants
F2214-23	Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
F2381-19	Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
F2625-10(2016)	Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
F2759-19	Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
ISO 10993	Biological Evaluation of Medical Devices, Parts 1-12
ISO 527	Plastics--Determination of Tensile Properties--Part 1: General Principles
D638-22	Standard Test Method for Tensile Properties of Plastics
D695-23	Standard Test Method for Compressive Properties of Rigid Plastics
D1898-68(1989)	Standard Practice for Sampling of Plastics (Withdrawn 1998)
D2765-16(2024)	Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
E647-23a	Standard Test Method for Measurement of Fatigue Crack Growth Rates (Includes all amendments and changes 6/27/2023).
F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
F648-21	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749-20	Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F756-17	Standard Practice for Assessment of Hemolytic Properties of Materials
F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
F813-20	Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895-11(2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F2003-02(2022)	Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
F2102-17	Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants