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ASTM F2759-11

Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices

Automaticky přeložený název:

Standardní Příručka pro posuzování Ultra High polyethylen (UHMWPE) Používá se v ortopedické a spinální zařízení

NORMA vydána dne 15.4.2011

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Provedení	PDF - okamžité stažení - 1 758.60 Kč Tištěné - 1 758.60 Kč
Dostupnost	SKLADEM
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Informace o normě:

Označení normy: ASTM F2759-11
Poznámka: NEPLATNÁ
Datum vydání normy: 15.4.2011
Kód zboží: NS-54487
Počet stran: 6
Přibližná hmotnost: 18 g (0.04 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

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Kategorie - podobné normy:

Implantáty pro chirurgii, protetiku a ortotiku

Anotace textu normy ASTM F2759-11 :

Keywords:
musculoskeletal joint replacement, orthopedic device, spinal device, UHMWPE, ultra-high molecular weight polyethylene, Musculoskeletal system, Orthopaedic medical devices, Orthopaedic spinal devices, Ultra-high molecular-weight polyethylene (UHMWPE), ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Doplňující informace

Significance and Use

This guide aims to provide guidance for a range of various assessments and evaluations to aid in preclinical research and device development of various UHMWPE components in orthopedic and spinal devices used for the repair of musculoskeletal disorders.

This guide includes brief descriptions of various assessments, representative data, processing conditions, and intended use or uses, as well as the qualitative and quantitative analyses of the UHMWPE powder to a finished product component.

The user is encouraged to use appropriate ASTM International and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE materials, device components, or devices before assessment of an in vivo model.

Assessments of UHMWPE should be performed in accordance with the provisions of 21 CFR 58 where feasible.

Studies to support investigational device exemption (IDE), premarket approval (PMA), or 510K submissions should conform to appropriate Food and Drug Administration (FDA) guidelines for the development of medical devices.

Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE components are not necessarily predictive of human results and should be, therefore, interpreted cautiously with respect to potential applicability to human conditions. Referenced UHMWPE publications can be found in the References section at the end of this guide for further review.

TABLE 1 UHMWPE Fabricated Forms and Conditions

1. Scope

1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a musculoskeletal joint. The UHMWPE components may include knee, hip, shoulder, elbow, ankle, total disc replacement, toe, finger, and wrist joint implant devices. This guide does not cover UHMWPE in fiber or tape forms.

1.2 This guide includes a description and rationale of assessments for the various UHMWPE types and processing conditions. Assessment testing based on physical, chemical, biocompatibility, mechanical, and preclinical analyses are briefly described and referenced. The user should refer to specific test methods for additional details.

1.3 This guide does not attempt to define all of the assessment methods associated with UHMWPE components in orthopedic and spinal devices.

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

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

F2695-12(2020)	Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F732-17	Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
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
D695-23	Standard Test Method for Compressive Properties of Rigid Plastics
D883-24	Standard Terminology Relating to Plastics
D2765-16(2024)	Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
D4020-18	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials
E647-23a	Standard Test Method for Measurement of Fatigue Crack Growth Rates (Includes all amendments and changes 6/27/2023).
D256-23e1	Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics (Includes all amendments and changes 4/7/2023).
D638-22	Standard Test Method for Tensile Properties of Plastics
F648-21	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for 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
F2423-11(2020)	Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
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
F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
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
F1714-96(2018)	Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
F1715-00e1	Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices (Withdrawn 2006)
F2003-02(2022)	Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
F2025-06(2018)	Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
F2102-17	Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
F2183-02	Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants