YY/T 0806-2010Polycarbonate material for manufacture of infusion, transfusion and injection equipments for medical use and other medical devices (English PDF)
医用输液、输血、注射及其他医疗器械用聚碳酸酯专用料
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 27, 2010
Implementation date
June 1, 2012
Scope
YY/T 0806-2010 is the English-translated version of 医用输液、输血、注射及其他医疗器械用聚碳酸酯专用料.
YY/T 0806-2010 is the Chinese pharmaceutical industry standard for the polycarbonate material used to make infusion, transfusion and injection equipment and other medical devices.
It sets the requirements for the material, covering its appearance and identification, the mechanical and thermal properties, the extractable substances and the residues of processing, the microbial limits and the biological evaluation, and it gives the test method for each. Issued on 27 December 2010, it applies from 1 June 2012.
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Document preview — YY/T 0806-2010
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Normative references5
- 3 Requirements6
- 4 Test method7
- 5 Marking9
- 6 Packaging and storage9
- References10
1 Scope
This Standard specifies the requirements for polycarbonate material for manufacture of infusion, transfusion and injection equipments for medical use and other medical devices This Standard does not apply to polycarbonate copolymers.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 1033.1-2008, Plastics - Methods for determining the density of non-cellular plastics - Part 1: Immersion method liquid pyknometer method and titration method (ISO 1183-1:2004, IDT)
GB/T 1843-2008, Plastics - Determination of izod impact strength
GB/T 2547-2008, Plastic resins - Sampling
GB/T 3682, Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics
GB/T 9352-2008, Plastic - Compression moulding of test specimens of thermoplastic materials
GB/T 14233.1-2008, Test methods for infusion transfusion injection equipments for medical use - Part 1: Chemical analysis methods
GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 2918-1998, Plastics - Standard atmospheres for conditioning and testing Visual inspection.
4 Test method
4.4 Physical properties
4.4.1 Melt volume-flow rate
Take particle samples according to GB/T 3682.
4.4.2 Density
Take particle samples according to method B in GB/T 1033.1-2008.
4.4.3 Izod notched impact strength
Take samples prepared in 5.1 and carry out according to method A in GB/T 1843-2008.
4.4.4 Radiation-resistant materials
For radiation-resistant sterilization polycarbonate materials for medical use, take a 3 mm-thick test piece; after 30 kGy radiation, place it under natural light conditions for 15 days; test the yellow index before and after radiation according to HG/T 3862.
4.5 Chemical properties of dissolved substances
4.5.1 Preparation of test solution
Weigh particle samples and use the class-2 test water as specified in GB/T 6682-2008 to rinse them; add water in a ratio of 1:5 of mass (g) to water (mL); seal with a lid; place them in a pressure steam sterilizer, at 121 °C ± 1 °C of saturated steam, for 30 min; separate the sample from the solution; cool to room temperature. Take the same batch of water to prepare blank control solution by the same method.
4.5.2 Reducing substance
Take the test solution and control solution, which are prepared according to 4.5.1, and carry out according to 5.2.2 of GB/T 14233.1-2008.
4.5.3 pH value
Take the test solution and control solution, which are prepared according to 4.5.1, and carry out according to 5.4.1 of GB/T 14233.1-2008.
4.5.4 Evaporation residue
Take the test solution and control solution, which are prepared according to 4.5.1, and carry out according to 5.5 of GB/T 14233.1-2008.
4.5.5 Metal ion
Take the test solution that is prepared according to 4.5.1, and carry out according to 5.6.1 of GB/T 14233.1-2008 and/or the atomic absorption spectrophotometry (AAS) or equivalent method.
4.5.6 UV absorbance
Take the test solution that is prepared according to 4.5.1, and carry out in the wavelength range of 250 nm ~ 320 nm according to the provisions of 5.7 of GB/T 14233.1-2008.
5 Marking
The marking on the outer packaging bag of the medical polycarbonate material product shall include the following contents:
a) Product name;
b) Manufacturer's name or trademark;
c) Model;
d) Batch number; e) Net weight.
6 Packaging and storage
6.1 Packaging
Polycarbonate materials for medical use shall be at least double-packed, and the packaging shall ensure that the product will not be contaminated during transportation and storage.
6.2 Storage
Polycarbonate materials for medical use shall be stored in a ventilated, dry and clean warehouse with well-maintained firefighting facilities. Store away from heat sources and avoid direct sunlight. […]
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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.
Referenced standards
Normative references
- GB/T 1033.1-2008Plastics -- Methods for determining the density of non-cellular plastics -- Part 1: Immersion method, liquid pycnometer method and titration method
- GB/T 1843-2008Plastics - Determination of izod impact strength
- GB/T 2547-2008Plastics — Sampling methods
- GB/T 3682Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics
- GB/T 9352-2008Plastic -- Compression moulding of test specimens of thermoplastic materials
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
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Related Standards
GB/T 1033.1-2008 — Plastics -- Methods for determining the density of non-cellular plastics -- Part 1: Immersion method, liquid pycnometer method and titration method
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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YY/T 0806-2010
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