YY/T 0242-2007Polypropylene material for manufacture of infusion transfusion and injection equipments for medical use (English PDF)
医用输液、输血、注射器具用聚丙烯专用料
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 2, 2007
Implementation date
March 1, 2008
Scope
YY/T 0242-2007 is the English-translated version of 医用输液、输血、注射器具用聚丙烯专用料.
YY/T 0242-2007 is the Chinese pharmaceutical industry standard for the polypropylene material used to make medical infusion, transfusion and injection equipment.
It divides the material into polypropylene homopolymer (PP-H) and random copolymer (PP-R) grades and sets the requirements for natural-colour granules, physical and mechanical properties such as notched Izod impact strength and melt mass-flow rate, and chemical and radiation-resistance properties, including haze for injection equipment grades, heavy metals and UV absorption.
It also gives the test methods, inspection rules, marking, packaging, transport and storage. It replaces YY 0242-1996, turning it into a recommended standard and adding the PP-R grade. Issued on 2 July 2007, it has applied since 1 March 2008.
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Document preview — YY/T 0242-2007
National Standard of the People's Republic of China
- Replacing
- YY 0242-1996
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Classification and symbols5
- 4 Requirements5
- 5 Test methods7
- 6 Inspection rules10
- 7 Marks11
- 8 Packaging, transportation and storage11
- References13
Foreword
This Standard replaces YY 0242-1996 Polypropylene material for manufacture of infusion, transfusion and injection equipment for medical use.
Compared with YY 0242-1996, the main changes of this Standard are as follows.
- ADJUST from mandatory standard to recommended standard.
- ADD the performance requirements of the polypropylene random copolymer (PP-R) for medical use.
- DIVIDE the PP-H and PP-R materials for medical use INTO the polypropylene material for manufacture of infusion, transfusion and for injection equipment.
- REVISE the test item "Cleanliness (color granules and irregular granules)" to "Granule appearance (color granules)".
- REVISE the test item "Izod impact strength" to "Notched izod impact strength". REVISE the unit from "J/m" to "kJ/m2". Respectively REVISE the PP-H index and PP-R index to ">= 2.0kJ/m2" and ">= 3.0kJ/m2".
- For the polypropylene material for manufacture of injection equipment, REVISE the test item "Transmissivity" to "Haze". The index is less than or equal to 15%.
- REVISE the test item "Melt flow rate" to "Melt mass-flow rate". MODIFY the index to (0.8-1.2) nominal value (provided by the supplier).
- INCREASE the index of heavy metal content to 1.0µg/mL.
- ADD the "UV absorption rate".
1 Scope
This Standard specifies the classification, symbols, requirements, test methods, inspection rules, marks, packaging, transportation and storage of the polypropylene material for manufacture of infusion, transfusion and injection equipments for medical use (hereinafter referred to as "polypropylene material for medical use").
This Standard applies to the polypropylene material for manufacture of infusion, transfusion and injection equipments for medical use.
2 Normative references
The provisions in the following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard. However, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest versions apply to this Standard.
GB/T 1033-1986 Test method for density and relative density of plastics
GB/T 1250-1989 Rules for expression and judgement of limiting values
GB/T 1843-1996 Plastics - Determination of izod impact strength (eqv ISO 180:1993)
GB/T 2409-1980 Plastics - Yellow index test method
GB/T 2410-1980 Transparent plastics - Transmissivity and haze test
GB/T 2546.2-2003 Plastics - Polypropylene (PP) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties
GB/T 2547-1981 Plastic resins - Sampling
GB/T 2918-1998 Plastics - Standard atmospheres for conditioning and testing (idt ISO 291:1997)
GB/T 3682-2000 Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics (idt ISO 1133:1997)
GB/T 9341-2000 Plastics - Determination of flexural properties (idt ISO 178:1993)
3 Classification and symbols
According to the molecular structure of polypropylene, the polypropylene material for medical use is divided into the polypropylene homopolymer (PP-H) material for medical use AND the polypropylene random copolymer (PP-R) material for medical use.
4 Requirements
4.1 Shape
The natural-color granules are used as the polypropylene material for medical use.
4.2 Physical and mechanical properties
See Table 1 for the requirements for the physical and mechanical properties of the polypropylene material for medical use.
4.3 Chemical and radiation-resistant properties
See Table 2 for the requirements for the chemical and radiation-resistant properties of the polypropylene material for medical use.
5 Test methods
5.1 Determination of limiting values
Use rounding-off values to determine the test results according to the provisions specified in the Article 5.2 of GB/T 1250-1989 if necessary.
5.2 Sample preparation
5.3 Sample status-conditioning and standard test environment
The sample status-conditioning shall be conducted according to the provisions of GB/T 2918-1998. The temperature of status-conditioning shall be within the range of 23°C ± 2°C. The conditioning time shall be at least 40h, but shall not be longer than 96h.
5.4 Physical and mechanical properties
5.4.1 Granule appearance
It shall conform to the provisions of SH/T 1541-2006.
5.4.3 Density
PREPARE the compression molding test pieces according to the Article 5.2.2.
CONDUCT status-conditioning to the test pieces according to the provisions specified in the Article 5.3.
5.4.5 Flexural modulus
According to the provisions of the Article 5.2.1, USE Type B moulds to prepare the injection strip samples in size of 80mm × 10mm × 4mm.
5.5 Chemical properties
5.5.1 Sample preparation
CONDUCT compression molding to the test samples according to the provisions of the Article 5.2.2. The thickness of test samples is 0.45mm ± 0.05mm.
5.5.4 Heavy metal content
TAKE the test solution prepared according to the Article 5.5.2.DETERMINE the heavy metal content according to the Article 5.6.1 of GB/T 14233.1-1998.
5.5.5 Cadmium content
TAKE the test solution prepared according to the Article 5.5.2.DETERMINE the cadmium content according to the Article 5.9.1 of GB/T 14233.1-1998.
5.6 Yellow index after the radiation (25kGy)
According to the provisions of the Article 5.2.1, USE Type D1 moulds to prepare the injection sample pieces in size of 60mm × 60mm × 1mm.
USE gamma-ray of 25kGy to radiate the sample pieces. The radiated sample pieces shall be used as test samples.
CONDUCT the test according to the provisions specified in the GB/T 2409-1980.
6 Inspection rules
6.1 Inspection classification and inspection items
The inspection of the polypropylene material for medical use can be divided into type inspection and exit-factory inspection.
6.2 Batch rules and sampling plans
6.2.1 Batch rules
The polypropylene material for medical use can be divided into batches according to the products produced on the same production line, same raw materials, same process and same brand. The products mixed in the warehouse or those produced in a certain production cycle can be deemed as one batch.
6.3 Determination and re-inspection rules
6.3.1 Determination rules
The inspection of the polypropylene material for medical use shall be conducted by the Quality Inspection Department according to the test methods specified in this Standard.
6.3.2 Re-inspection rules
If there are any inspection results that do not conform to the standard provisions, TAKE double sampling units from this batch of products again. RE-INSPECT the unqualified items. If the re-inspection results are still unqualified, this batch of products shall be determined as unqualified.
7 Marks
There shall be obvious marks on the outer packaging bags of the polypropylene material for medical use. The marks shall include trademark, plant name,
8 Packaging, transportation and storage
8.1 Packaging
The polypropylene material for medical use shall be sealed in the inner packaging bags.
8.2 Transportation
The polypropylene material for medical use belongs to non-dangerous goods.
DO NOT use iron hooks or other sharp tools during the transportation, loading and unloading.
8.3 Storage
STORE the polypropylene material for medical use in the well-ventilated, dry and clean warehouses with good fire-fighting facilities. KEEP away from the heat source during the storage. […]
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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 1843-1996Plastics - Determination of izod impact strength
- GB/T 2410-1980Determination of the Luminous Transmittance and Haze of Transparent Plastics
- GB/T 2546.2-2003Plastics - Polypropylene(PP) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties
- GB/T 2547-1981Plastics — Sampling methods
- GB/T 2918-1998Plastics -- Standard atmospheres for conditioning and testing
- GB/T 3682-2000Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics
GB/T 1033-1986 · GB/T 1250-1989 · GB/T 2409-1980
Similar standards
Editions of YY/T 0242
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0242-2007 | Polypropylene material for manufacture of infusion transfusion and injection equipments for medical use | current edition | Current |
| YY 0242-1996 | Polypropylene material for manufacture of infusion transfusion and injection equipments for medical use | previous edition | Superseded |
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