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YY/T 1507.1-2016Determination of impurity elements in ultra-high molecular weight polyethylene powder for surgical implants - Part 1: Determination of titanium by ICP-MS (English PDF)

外科植入物用超高分子聚乙烯粉料中杂质元素的测定第1部分:ICP-MS法测定钛(Ti)元素含量

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 29, 2016

Implementation date

July 29, 2016

Scope

YY/T 1507.1-2016 is the English-translated version of 外科植入物用超高分子聚乙烯粉料中杂质元素的测定第1部分:ICP-MS法测定钛(Ti)元素含量.

YY/T 1507.1-2016 is the Chinese pharmaceutical industry standard that gives the inductively coupled plasma mass spectrometry method for determining titanium in the ultra-high molecular weight polyethylene powder used in surgical implants.

It is the first part of the YY/T 1507 series on the impurity elements of that powder and sets out the reagents, the digestion of the sample, the calibration and the measurement, and the calculation and reporting of the titanium content. Issued on 29 July 2016, it has applied since that date.

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Document preview — YY/T 1507.1-2016

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
  • 3 Principle
  • 4 Reagent
  • 5 Instruments
  • 6 Steps

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 1 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 determination of titanium in ultra-high molecular weight polyethylene powder by inductively coupled plasma mass spectrometry (ICP-MS) (Ti) element.

This part is applicable to the determination of titanium (Ti) elements 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)

3 Principle

After the sample is digested by acid, the digestion liquid is atomized from the carrier gas (argon) into the ICP torch, and after evaporation, dissociation, atomization, electricity From the process, most of the conversion into a positively charged positive ions, the ion collection system into the mass spectrometer, mass spectrometer according to its mass to charge ratio from. For a certain mass-to-charge ratio, the mass spectral integration area is proportional to the number of ions entering the mass spectrometer, that is, the concentration of the sample to be measured in the sample Integral area or mass spectrum is proportional to high. The concentration of titanium (Ti) in the sample can therefore be determined by measuring the mass spectral area or the mass spectrum peak height.

4 Reagent

4.1 Except as otherwise provided, only reagents recognized as excellent grade pure or higher purity and primary water in accordance with GB/T 6682 are used.

4.3 Titanium Standard stock solution. 100 µg/mL (5% H2SO4 medium)

4.2 Nitric acid (HNO3). mass fraction of 65%, electronic grade

.

5 Instruments

5.2 Microwave digestion system

5.1 Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

6 Steps

6.1 Preparation of test solution

Accurately weigh 0.2 g of sample (accurate to 0.1 mg) in digestion tank, add 5 mL of nitric acid (see 4.2) and place in a microwave digestion system 5.2). Set the appropriate microwave digestion procedures (see Table 1), to be completely after the solution at 150 °C heating plate heated to near dry, water

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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