YY/T 1640-2018 in English

VALID

Implants for surgery―Standard test method for dissolution testing of calcium phosphate granules,fabricated forms and coatings

Issued on:2018-12-20
Implemented on:2020-01-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $160.00
$156.00

Standard No:	YY/T 1640-2018
Document status:	VALID
Title in English:	Implants for surgery―Standard test method for dissolution testing of calcium phosphate granules,fabricated forms and coatings
Title in Chinese:	外科植入物磷酸钙颗粒、制品和涂层溶解性的试验方法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2018-12-20
Implemented on:	2020-01-01
ICS Classification:	11.040.40-Implants for surgery, prosthetics and orthotics
Chinese Classification:	C35-Orthopedic devices
Professional Classification:	YY-Pharmaceutics
Related Keywords:	standard test method calcium phosphate granules coatings introductionthis standard calcium phosphate particles dissolution testing
Related Topics:	Particulate Matter Method Validation Particulate Matter Method Validation . materials for surgical implants . quantification of the calcium phosphate ratio of calcium phosphate Method Validation Particulate Matter calcium phosphate for surgical implants Surgical + Calcium Phosphate as1640 Particulate Matter Test Method Soluble particulate matter surgical calcium phosphate calcium sulfate for surgical implants plant calcium Materials for Surgical Implants--Quantification of Calcium Phosphate/Phosphorus Ratio calcium in plants Plant slide preparation method Plant mixed acid wet digestion Methods for appearance detection of calcium hydrogen phosphate yy/t1630-2018 Primer dissolution method Plant exosome verification method The correct way to dissolve primers Plant digestion method yy/t1615-2018

本标准规定了评价磷酸钙材料溶解速率的试验方法。本标准适用于外科植入物用磷酸钙材料，包括符合GB 23101.1、GB 23101.2的羟基磷灰石，符合YY/T 0683规定的β-磷酸三钙和无添加或添加了其他次要成分（＜10%）的双相复合物等。

Introduction

This standard provides a method for determining the solubility of calcium phosphate particles, products, and coatings used in surgical implants. It outlines procedures for testing the dissolution behavior under controlled conditions, ensuring consistent evaluation of material performance. The methodology includes preparation of test samples, selection of dissolution media, and measurement of dissolved substances. The standard specifies parameters such as temperature, pH, and agitation speed to ensure reproducibility. It also details the analysis techniques for quantifying the amount of dissolved material. The guidance is intended for use in quality control and research settings to assess the biocompatibility and degradation characteristics of calcium phosphate-based implants.

*** Please note: This description may not be accurate, please refer to the official documentation.

More samples: JJG 21-2008 YD/T 3934-2021 NB/T 47013.2-2015

Sample only — not a preview of YY/T 1640-2018

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