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ASTM F981-99

Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

Automaticky přeložený název:

Standardní praxe pro posouzení slučitelnosti biomateriálů pro chirurgických implantátů s ohledem na Vliv materiálů na Svaly a kosti

NORMA vydána dne 10.5.1999

Jazyk
Provedení	PDF - okamžité stažení - 2 005.90 Kč Tištěné - 2 005.90 Kč
Dostupnost	SKLADEM
Cena	2005.90 Kč bez DPH
2 005.90 Kč

Informace o normě:

Označení normy: ASTM F981-99
Poznámka: NEPLATNÁ
Datum vydání normy: 10.5.1999
Kód zboží: NS-57159
Počet stran: 5
Přibližná hmotnost: 15 g (0.03 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

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Anotace textu normy ASTM F981-99 :

Keywords:

Biocompatibility, Bone implant materials, Cellular reaction, Histology/Histopathology, Implants, Muscle, New Zealand rabbits, Orthopaedic medical devices-bone, Plastic surgical devices/applications, Polyethylene (PE)-surgical implant applications, Rabbits, Rats, Scar, Test animals, Tissue compatibility, Tissue response evaluation, compatibility of biomaterials (nonporous) for surgical implants with, respect to effect of materials on muscle/bone, practice

Doplňující informace

1. Scope

1.1 This practice provides a series of experimental protocols for biological assays of tissue reaction to nonabsorbable biomaterials for surgical implants. It assesses the effects of the material on animal tissue in which it is implanted. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material. It applies only to materials with projected applications in human subjects where the materials will reside in bone or soft tissue in excess of 30 days and will remain unabsorbed. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials will consist of any one of the metal alloys in Specifications F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648 or USP polyethylene negative control.

1.2 This document is a combination of Practice F361-80 and Practice F469-78. The purpose, basic procedure, and method of evaluation of each type of material are similar; therefore, they have been combined.

1.3 This standard does not purport to address all of the safety problems, 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

F67-13(2017)	Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F75-23	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
F648-21	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F603-12(2020)	Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
F562-22	Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
F469-78	Practice for Assessment of Compatibility of Nonporous Polymeric Materials for Surgical Implants with Regard to Effect of Materials on Tissue (Withdrawn 1987)
F361-80	Practice for Assessment of Compatibility of Metallic Materials for Surgical Implants With Respect to Effect of Materials on Tissue (Withdrawn 1987)
F138-19	Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F136-13(2021)e1	Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) (Includes all amendments and changes 8/19/2021).
F86-21	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F90-23	Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

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