YY/T 1404-2016Requirements and tests for copper used for IUD (English PDF)
含铜宫内节育器用铜的技术要求与试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 23, 2016
Implementation date
January 1, 2017
Scope
YY/T 1404-2016 is the English-translated version of 含铜宫内节育器用铜的技术要求与试验方法.
YY/T 1404-2016 is the Chinese pharmaceutical industry standard for the copper used in copper-bearing intrauterine devices.
It sets the chemical composition, the requirements and the test methods for the copper and copper alloy raw material, covering the purity and the limits on impurities, the form and the dimensions of the wire or sleeve, the surface condition and the corrosion behaviour that governs how the device releases copper ions. Issued on 23 March 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1404-2016
National Standard of the People's Republic of China
- ICS
- 11.200
- Classification
- C 36
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Chemical composition
- 4 Requirements
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the chemical composition, requirements and test methods for copper containing copper intrauterine devices.
This standard applies to copper and copper IUD used copper and copper raw materials.
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 5121.27-2008 Methods for chemical analysis of copper and copper alloys - Part 27. Inductively coupled plasma atomic emission Spectrum method
GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (GB/T 16886.12- 2005, ISO 10993-12.:2002, IDT)
3 Chemical composition
According to the method specified in Chapter 5, the minimum content of copper is 99.99%. Where the individual impurity metal content is not greater than that in Table 1 Regulations.
4 Requirements
4.1 Purity of copper
4.1.1 Copper content in copper raw materials shall comply with the provisions of Chapter 3.
4.1.2 copper raw materials impurity metal content should be consistent with the provisions of Table 1.
4.2 Surface quality
4.2.1 copper raw material surface should be clean, no sludge, oil and other pollutants.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
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Related Standards
GB/T 16886.12-2000 — Biological evaluation of medical devices--Part 12: Sample preparation and reference materials
GB/T 16886.12-2005 — Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
GB/T 16886.12-2017 — Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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YY/T 1404-2016
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