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YY/T 1507.2-2016: Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder--Part 2: Determination of chlorine by ion chromatography
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YY/T 1507.2-2016: Determination the content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder--Part 2: Determination of chlorine by ion chromatography

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Determination of content of impurity element in the implant for surgery ultra-high molecular weight polyethylene powder - Part 2. Determination of chlorine by ion chromatography ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Surgical implants are made of ultra high molecular weight polyethylene Determination of impurity elements in powder materials - Part 2. Determination of Chlorine (Cl) Content by Ion Chromatography ultra-highmolecularweightpolyethylenepowder-Part 2. Determination of 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued

Foreword

YY/T 1507 "Determination of impurity elements in ultra-high molecular weight polyethylene powder for surgical implants" is divided into the following four parts. Part 1. Determination of titanium (Ti) content by ICP-MS method; Part 2. Determination of Chlorine (Cl) Element Content by Ion Chromatography; Part 3. Determination of calcium (Ca) content by ICP-MS method; Part 4. Determination of aluminum (Al) content by ICP-MS method. This part is part 2 of YY/T 1507. This part is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This section is proposed by the State Food and Drug Administration. This section is under the jurisdiction of the National Standardization Technical Committee on Surgical Implants and Orthopedic Instruments (SAC/TC110). This part of the drafting unit. Tianjin Medical Device Quality Supervision and Inspection Center, the State Food and Drug Administration medical equipment technical review center. This part of the main drafters. Jiang Xi, Li Yuan, Fu Ruizhi, Fan platinum, Liu Yinghui, Sun Jiayi. Surgical implants are made of ultra high molecular weight polyethylene Determination of impurity elements in powder materials - Part 2. Determination of Chlorine (Cl) Content by Ion Chromatography

1 Scope

This part of YY/T 1507 specifies the combustion of the material in a closed system containing oxygen (calorie high pressure tank) and uses ion chromatography A method for quantitative analysis of the content of chlorine (Cl) in the combustion products. This part applies to the determination of chlorine (Cl) in ultra high molecular weight polyethylene powders for surgical implants.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 6682 Analytical laboratory water specifications and test methods (GB/T 6682-2008, ISO 3696. 1987, MOD) Terminology and Definitions The following terms and definitions apply to this document. 3.1 Chlorine content of chlorineelementcontent The total amount of chlorine (Cl) present in the form of organic and inorganic compounds can be converted to chloride by combustion and then absorbed and/or dissolved Solution.

4 principle

In a closed system (a high pressure tank containing oxygen), the sample is oxidized by combustion to convert the chlorine-containing compound into chloride and And/or dissolved in the absorption solution.

5 reagent

5.1 Unless otherwise specified, only reagents identified as excellent grade pure or higher purity and primary water in accordance with GB/T 6682 are used. 5.2 sodium carbonate, excellent grade pure. 5.3 sodium bicarbonate, excellent grade pure. 5.4 Chlorine (Cl-) standard stock solution, 1000 μg/mL (aqueous medium).

6 instruments

6.1 Oxygen bomb combustion device 6.1.1 Oxygen bombs. ...