ASTM F2346-05(2011)..
ASTM F2381-10
ASTM F2385-04(2010)..
ASTM F2392-04(2010)..
ASTM F2393-12
ASTM F2401-04(2010)..
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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
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
Kategorie - podobné normy:
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |
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| 1. Scope | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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. |
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| 2. Referenced Documents | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Podobné normy:
Historická
1.12.2011
Historická
1.6.2010
Historická
15.8.2010
Historická
1.9.2010
Historická
1.3.2012
Historická
1.5.2010
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