YY/T 0242-2007 PDF English
US$110.00 · In stock · Download in 9 secondsYY/T 0242-2007: Polypropylene material for manufacture of infusion, transfusion and injection equipment for medical use Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY/T 0242: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0242-2007 | English | 110 |
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Polypropylene material for manufacture of infusion, transfusion and injection equipment for medical use
| Valid |
| YY 0242-1996 | English | 319 |
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3 days
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(Medical infusion, transfusion, Polypropylene syringe)
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY/T 0242-2007
YY/T 0242-2007: Polypropylene material for manufacture of infusion, transfusion and injection equipment for medical use
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0242-2007
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)
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 γ-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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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