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YY/T 0242-2007 English PDF (YYT0242-2007)

YY/T 0242-2007 English PDF (YYT0242-2007)

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YY/T 0242-2007: Polypropylene material for manufacture of infusion, transfusion and injection equipment for medical use
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.
YY/T 0242-2007
YY
ICS 11.040.20
C 31
Pharmaceutical Industry Standard
of the People’s Republic of China
Replacing YY 0242-1996
Polypropylene material for manufacture of infusion,
transfusion and injection equipments for medical use
ISSUED ON. JULY 2, 2007
IMPLEMENTED ON. MARCH 1, 2008
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Classification and symbols ... 5
4 Requirements ... 5
5 Test methods ... 7
6 Inspection rules ... 10
7 Marks ... 11
8 Packaging, transportation and storage ... 11
References ... 13
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”.
This Standard was proposed by and shall be under the jurisdiction of the National Standardization Technical Committee for the Infusion Equipment for Medical Use (SAC/TC106).
Drafting organizations of this Standard. Resin Research Institute of SINOPEC Qilu Petrochemical Industry Corporation, and Resin Application Research Institute of SINOPEC Beijing Yanshan Company.
Main drafters of this Standard. Fan Dongxing, Zhang Chao, Li Jing, Wang Xiaojuan, Wang Dexin, and Bao Chunwei.
Polypropylene material for manufacture of infusion,
transfusion and injection equipments for medical use
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)
Note. The biological test methods specified in the GB/T 14233.2 shall be considered as the supplement of the methods specified in the GB/T 16886.
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
5.2.1 Injection sample preparation
PREPARE the injection samples according to the provisions specified in the Article 3.2 of GB/T 2546.2-2003.
The Type 1A samples specified in the ISO 527-2.1993 refer to the Type A samples that are prepared by using the Type A moulds specified in the standard of GB/T 17037.1-1997. The Type B samples prepared by using the Type B
moulds refer to the strip samples in size of 80mm × 10mm × 4mm.
The injection samples in size of 60mm × 60mm × 1mm, which are prepared by using the Type D1 moulds specified in the standard of GB/T 17037.3-2003, can be used for haze determination.
5.2.2 Preparation of compression molding samples
The preparation of compression molding samples shall be conducted according to the Article 3.3 of GB/T 2546.2-2003.
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.
All the tests shall be conducted in the standard environment (23/50) specified in the GB/T 2918-1998. The environment temperature t shall be within the range of 23°C ± 2°C. The relative humidity shall be within the range of 50% ± 10%. 5.4 Physical and mechanical properties
5.4.1 Granule appearance
5.4.6 Notched izod impact strength
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. PROCESS notches on the strip samples within 1h to 4h after the injection molding. PROCESS Type A notches specified in the GB/T 1843-1996. The strip samples with notches shall be used as the test samples for conducting the notched izod impact test. CONDUCT status-conditioning to the test samples according to the provisions specified in the Article 5.3.
CONDUCT the test according to the provisions specified in the GB/T 1843-1996. 5.4.7 Haze
According to the provisions of the Article 5.2.1, USE Type D1 moulds to prepare the injection samples in size of 60mm × 60mm × 1mm.
CONDUCT the test according to the provisions specified in the GB/T 2410-1980. 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.
5.5.2 Test solution preparation
FLUSH the test samples prepared according to the provisions of the Article 5.5.1. CUT them into small pieces in size of 1cm2. ADD water according to the ratio that total area (cm2) to distilled water (mL) is 5.1. USE cover for sealing. PUT the mixture in the steam sterilizer filled with saturated vapor at 121°C ± 1°C for 30min. SEPARATE samples from the liquid. COOL down to room
temperature. TAKE the same batch of distilled water. USE the same method to prepare the blank control solution.
5.5.3 pH value
Respectively TAKE the test solution and control solution prepared according to the Article 5.5.2. DETERMINE their pH values according to the Article 5.4.1 of GB/T 14233.1-1998.
5.5.4 Heavy metal content
TAKE the test solution prepared according to the Article 5.5.2. DETERMINE the 6.2.2 Sampling scheme
The manufacturers can take samples at the sampling ports of warehouses. The packed products shall conform to the provisions specified in the GB/T 2547-1981.
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. CONDUCT quality determination to the products, and PUT forward the certification according to the inspection results and technical requirements.
When the products exit from the factory, each batch of products shall have product quality inspection certificate. The product name, brand, batch number, executive standard, and qualified identification shall be noted on the certificate. Furthermore, the certificate shall also be stamped with the special seal for quality inspection and the seal(s) of inspector(s).
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 ...
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