ASTM-F981:2023 Edition(Redline)

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F981-23 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices (Redline)

Published By	Publication Date	Number of Pages
ASTM	2023	9

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

ASTM F981-23

Redline Standard: Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

ASTM F981

Scope

1.1 This practice provides guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the effects of the material that is implanted intramuscularly or intraosseously. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, or mutagenicity of the material since other standards address these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or skeletal muscle tissue in excess of 30 days. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials are well recognized with a well-characterized long-term response and can include metals and any one of the metal alloys in Specification 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 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems of measurement are included in this standard.

1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F0981-23

Additional information

Standard Title	F981-23 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices (Redline)
Published Code	ASTM
Publication Date	2023
Pages Count	9
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics