YY/T 1507.2-2016Determination of impurity elements in ultra-high molecular weight polyethylene powder for surgical implants - Part 2: Determination of chlorine by ion chromatography (English PDF)
外科植入物用超高分子量聚乙烯粉料中杂质元素的测定第2部分：离子色谱法测定氯（Cl）元素含量
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1507.2-2016 is the English-translated version of 外科植入物用超高分子量聚乙烯粉料中杂质元素的测定第2部分：离子色谱法测定氯（Cl）元素含量.
YY/T 1507.2-2016 is the Chinese pharmaceutical industry standard that gives the method for determining chlorine in the ultra-high molecular weight polyethylene powder used in surgical implants, by burning the material in a closed oxygen-filled vessel, the calorimetric bomb, and analysing the combustion products by ion chromatography.
It is the second part of the YY/T 1507 series and sets out the combustion and the absorbing solution, the chromatographic conditions and the calculation of the chlorine content. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1507.2-2016
National Standard of the People's Republic of China
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 4 Principle
- 5 Reagent
- 6 Instruments
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.
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 document. 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
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.
5.4 Chlorine (Cl-) standard stock solution, 1000 µg/mL (aqueous medium)
5.3 sodium bicarbonate, excellent grade pure
5.2 sodium carbonate, excellent grade pure
6 Instruments
6.1 Oxygen bomb combustion device
6.1.1 Oxygen bombs
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
YY/T 1507.3-2016 — Determination of impurity elements in ultra-high molecular weight polyethylene powder for surgical implants - Part 3: Determination of calcium by ICP-MS
YY/T 1507.1-2016 — Determination of impurity elements in ultra-high molecular weight polyethylene powder for surgical implants - Part 1: Determination of titanium by ICP-MS
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