ASTM F1088-87(1992)e1

Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation (Includes all amendments And changes 8/16/2017).

Automatically translated name:

Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

STANDARD published on 1.1.1992

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The information about the standard:

Designation standards: ASTM F1088-87(1992)e1
Note: WITHDRAWN
Publication date standards: 1.1.1992
SKU: NS-49090
The number of pages: 2
Approximate weight : 6 g (0.01 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F1088-87(1992)e1 :

Keywords:

Alpha-tricalcium phosphate, Beta-tricalcium phosphate, Bone implant materials, Ceramic materials, Crystallographic properties, Orthopaedic medical devices, Tribasic calcium phosphate, Whitlockite, beta-tricalcium phosphate (for surgical implantation), spec, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

1. Scope

1.1 The specification defines the chemical and crystallographic properties of beta-tricalcium phosphate intended for surgical implantation. It also informs the user that manufacturers and distributors are obligated to meet certain federal requirements.

1.2 It has been found that material meeting this specification engenders an acceptable biocompatible response as defined in Practice F981 (1). Other properties of calcium phosphates such as grain size, density, strength, and resorption rates are dependent upon certain process parameters (2-9).

1.3 This specification excludes tribasic calcium phosphate, whitlockite, alpha-tricalcium phosphate, and hydro-xyapatite.

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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