ASTM F1088-18

Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

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STANDARD published on 15.11.2018

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The information about the standard:

Designation standards: ASTM F1088-18
Note: WITHDRAWN
Publication date standards: 15.11.2018
SKU: NS-910515
The number of pages: 3
Approximate weight : 9 g (0.02 lbs)
Country: American technical standard
Category: Technical standards ASTM

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The category - similar standards:

Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F1088-18 :

Keywords:

advanced ceramics, beta-TCP, beta-tricalcium phosphate, calcium phosphate material, ceramic, surgical implant,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

1. Scope

1.1 This specification covers chemical and crystallographic requirements for beta-tricalcium phosphate (β-TCP) for surgical implant applications. For a material to be identified as medical-grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1).

1.2 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.

2. Referenced Documents

ISO 10993	Biological Evaluation of Medical Devices Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
C1	Specification of General Requirements for a Quality Program Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Heavy Metals <231> Method 1

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