YY/T 1532-2017Biological evaluation of medical devices—Nanomaterials—Hemolysis test (English PDF)
医疗器械生物学评价纳米材料溶血试验
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 28, 2017
Implementation date
April 1, 2018
Scope
YY/T 1532-2017 is the English-translated version of 医疗器械生物学评价纳米材料溶血试验.
YY/T 1532-2017 is the Chinese pharmaceutical industry standard that gives the haemolysis test for nanomaterials and for medical devices containing them, where such material touches blood directly or indirectly or can be released from the device.
It sets out the preparation of the sample and of the extract, the exposure to blood, the controls and the measurement of free haemoglobin, with the precautions that the small size of the particles makes necessary in separating them before the absorbance is read. Issued on 28 March 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1532-2017
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 30
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms, definitions and abbreviations
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the direct/indirect contact with the blood of nano-materials and the combination of nano-materials in medical devices hemolytic performance test method.
This standard applies to direct/indirect contact with the blood of nano-materials and the combination of medical devices in the free or release of nano-materials dissolved Blood performance evaluation.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and test in risk management process (GB/T 16886.1- 2011, ISO 10993-1:2009, IDT)
GB/T 16886.4 Biological evaluation of medical devices - Part 4. Interaction with blood test selection (GB/T 16886.4- 2003, ISO 10993-4:2002, IDT)
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 Terms, definitions and abbreviations
3.1 Terms and definitions
GB/T 16886.1, GB/T 16886.4 as defined in the following terms and definitions apply to this document.
3.1.1 Methemoglobin
Iron atoms have been oxidized to high ferric ion hemoglobin.
3.1.2 Cyanide methemoglobin
Iron atoms are oxidized to high-iron ions, high-speed iron ions have been combined with cyanide hemoglobin.
3.1.3 Total hemoglobin
All hemoglobin derivatives normally present in human circulating blood include deoxyhemoglobin, oxyhemoglobin, hemoglobin hemoglobin White, carboxyhemoglobin and methemoglobin.
3.2 Abbreviations
The following abbreviations apply to this document.
Cal. Calibration Standard CMH. Cyanmethemoglobin DPBS. Dulbecco's phosphate-free phosphate buffer (Dulbercco's Phosphate Buffered Saline)
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 16886.4Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- GB/T 16886.12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.12-2023 — Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
GB/T 16886.4-2022 — Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
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