YY/T 0908-2013 English PDF (YYT0908-2013)

This Standard specifies classification and marking, materials, physical requirements, chemical requirements, biological requirements, signs, packaging for single-use filter for syringe.

YY/T 0908-2013
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Single-use filter for syringe
ISSUED ON: OCTOBER 21, 2013
IMPLEMENTED ON: OCTOBER 01, 2014
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Classification and marking ... 5
4 Materials ... 6
5 Physical requirements ... 6
6 Chemical requirements ... 7
7 Biological requirements ... 8
8 Signs ... 9
9 Packaging ... 10
Annex A (Normative) Physical test ... 11
Annex B (Normative) Type inspection rules ... 15
Single-use filter for syringe
1 Scope
This Standard specifies classification and marking, materials, physical requirements, chemical requirements, biological requirements, signs,
packaging for single-use filter for syringe.
This Standard is applicable to single-use filter for syringe (hereinafter referred to as the filter). The filter is used in conjunction with injection equipment. It is used in intramuscular injection, intravenous injection of drugs, and adding drugs to liquid bottles in clinical treatment. It is used to filter insoluble particles in liquid medicine.
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 1962.1, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement
GB/T 1962.2, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
GB/T 6682, Water for analytical laboratory use - Specification and test methods
GB 8368, Infusion sets for single use - Gravity feed
GB/T 14233.1-2008, Test methods for infusion, transfusion, injection
equipment for medical use - Part 1: Chemical analysis methods
GB/T 14233.2, Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
GB 15810, Sterile syringes for single use
GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY 0321.3, Single-use filter for anesthesia
When tested according to the indirect titration method in GB/T 14233.1-2008, the difference between the volume of the potassium permanganate solution [c(KMnO4)=0.002mol/L] consumed by the test solution and the blank solution shall not exceed 2.0mL.
6.3 Metal ion
When testing according to 5.6.1 in GB/T 14233.1-2008, the color of the test solution shall not exceed the standard control solution with mass concentration of ρ(Pb2+)=1μg/mL.
When testing according to atomic absorption spectrophotometry in GB/T
14233.1-2008, the content of cadmium shall not exceed 0.1μg/mL.
6.4 pH
Carry out the test according to acidity meter method in GB/T 14233.1-2008, and the pH difference between the test solution and the blank solution shall not exceed 1.0.
6.5 Residual amount of ethylene oxide
If ethylene oxide is used for sterilization, after the filter is sterilized, when it is tested according to GB/T 14233.1-2008, the residual amount shall not exceed 10μg/g.
7 Biological requirements
7.1 General
For the filter, when new products are put into production, when material changes significantly, the biological evaluation of cytotoxicity, irritation or intradermal reaction, sensitization, acute systemic toxicity, pyrogenic reaction and hemocompatibility shall be carried out according to GB/T 16886.1.
7.2 Sterilization
The filter shall be sterilized by a sterilization-validated process and routine controls.
NOTE 1: See GB 18278, GB 18279 and GB 18280 for suitable sterilization confirmation and routine control.
NOTE 2: Sterility test methods are specified in GB/T 14233.2. This method can be used for type test and is not suitable for factory inspection.
NOTE 3: If the product is provided in a non-sterile state, it shall be clearly marked on the package that "unsterilized, not for direct clinical use".
7.3 Bacterial endotoxin
When the filter is tested according to GB/T 14233.2, its content shall not exceed 20EU/piece (or piece).
8 Signs
8.1 Initial packaging
The initial packaging shall contain at least the following information: a) Product name and specification marking in compliance with Chapter 3; b) Manufacturer's name and address;
c) Product registration certificate number, implementation standard number; d) Use the graphic symbols given in YY/T 0466.1, indicating the filter is sterile. If the product is provided in a non-sterile state, it shall be clearly marked in red on the package: "Unsterilized, not for direct clinical use”;
e) The filter is pyrogen-free;
f) The filter is for one-time use only, or equivalent instructions, or use the graphic symbols given in YY/T 0466.1;
g) Instructions for use, including checking the integrity of the package seal and warnings about detachment of the protective cover;
h) Production batch number, beginning with the word "batch" or "LOT", or using the graphic symbols given in accordance with YY/T 0466.1;
i) Expiration date, with appropriate text, or use the graphic symbols given in accordance with YY/T 0466.1;
j) Label the filter nominal pore size.
8.2 Outer packaging
At least the following information shall be on the outer packaging:
a) Product name and specification marking in compliance with Chapter 3; b) Manufacturer's name and address;
c) Use the graphic symbols given in YY/T 0466.1 to indicate that the filter is sterile. If the product is provided in a non-sterile state, it shall be clearly marked in red on the package, "Unsterilized, not for direct clinical use"; d) Lot number, beginning with the word "batch" or "LOT", or use the graphic symbols given in accordance with YY/T 0466.1;
e) Expiration date, with appropriate text, or use the graphic symbols given in accordance with YY/T 0466.1;
f) Recommended storage conditions, if available.
9 Packaging
9.1 Each filter shall be packaged in the primary packaging.
When using ethylene oxide for sterilization, the primary packaging of the filter shall be a packaging material with one side of dialysis paper and the other side of plastic material or full dialysis paper. This Standard encourages the use of packaging materials with better dialysis effects. Packaging materials must not have a detrimental effect on the contents. The materials and design of this packaging shall ensure that:
a) Under dry, clean and adequately ventilated storage conditions, the
contents can be guaranteed to be sterile;
b) The risk of contamination of contents is minimum when removed from
packaging;
c) The contents are adequately protected during normal handling, transport and storage;
d) Once opened, the package cannot be easily resealed and there shall be visible signs of tearing.
9.2 One or more pieces of initial packaging shall be packed into one piece of intermediate packaging.
During normal handling, transportation and storage, the middle packaging shall be able to protect the contents fully and effectively.
9.3 If the product is provided in a non-sterile state, it shall be determined by the manufacturer.