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YY/T 0979-2016 PDF in English


YY/T 0979-2016 (YY/T0979-2016, YYT 0979-2016, YYT0979-2016)
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YY/T 0979-2016: PDF in English (YYT 0979-2016)

YY/T 0979-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.200
C 36
Intra-uterine suction curettes for single use
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 01, 2017
Issued by. China Food and Drug administration
Table of Contents
Foreword . 3 
1 Scope .. 4 
2 Normative references . 4 
3 Structural type and material . 5 
4 Requirements . 7 
5 Test methods .. 8 
6 Inspection rules .. 10 
7 Markings and instructions for use . 11 
8 Packaging, transportation and storage . 12 
Appendix A (Normative) Marking – Packaging . 14 
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Attention shall be drawn to the possibility that some of the elements of this
Standard may be the subject of patent rights. The issuing authority shall not be
held responsible for identifying any or all such patent rights.
This Standard was proposed by the State Food and Drug Administration of the
People's Republic of China
This Standard shall be under the jurisdiction of the National standardization
technical committee for family planning devices. (SAC/TC 169).
The drafting organizations of this standard. Tianjin Medical device Factory,
China Food and Drug Administration, Shanghai Medical Device Quality
Supervision and Inspection Center, Beijing Yuanhao Huaxin Science and
Technology Co., Ltd.
The main drafters of this standard. Jian Dehong, Yao Tianping, Jia Fuhua,
Huang Shuze, Wang Shiyuan.
Intra-uterine suction curettes for single use
1 Scope
This standard specifies the structural type and material, requirements, test
methods, inspection rules, marking and instructions for use, packaging,
transportation and storage of intra-uterine suction curettes.
This standard is applicable to single-use intra-uterine suction curettes
(hereinafter referred to as suction curette) which is connected to a suction
device for performing negative pressure suction operation on early pregnant
women.
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 2828.1 Sampling procedures for inspection by attributes - Part 1.
Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot
inspection
GB/T 2829 Sampling procedures and tables for periodic inspection by
attributes (apply to inspection of process stability)
GB/T 9969 General principles for preparation of instructions for use of
industrial products
GB/T 14233.1-2008 Test methods for infusion, transfusion, injection
equipment for medical use - Part 1. Chemical analysis methods
GB/T 16886.5 Biological evaluation of medical devices - Part 5. Test for in
vitro cytotoxicity
GB/T 16886.10 Biological evaluation of medical devices - Part 10. Tests for
irritation and sensitization
YY/T 0466.1 Medical devices. Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1. General
requirements
5.5 Negative pressure resistance
Connect one end of the suction curette to a vacuum device and seal the other
end. Under (25±2)°C, apply negative pressure according to Table 2 for 30s.
Shall conform to the requirements in 4.5.
5.6 Cavity smoothness
5.6.1 Single/ double cavity suction curette
Take a syringe no less than 30mL and take sufficient amount of water. Connect
the joint end of the suction curette (or the main tube of a double cavity suction
curette) with the cone head of the syringe, push the core rod, so that the water
in the syringe is discharged from the suction end of the suction curette. There
shall be no obvious resistance. Shall conform to the requirements of 4.6.
5.6.2 Accessory tube of double cavity suction curette
Take one syringe filled with water. Inject water from either side of the accessory
tube with the syringe needle. There shall be water discharged from the other
side. Shall conform to the requirements of 4.6.
5.7 Sterile
Inspect according to 1101 sterility test method in the "Pharmacopoeia of the
People's Republic of China Fourth Part" (2015 edition). Shall conform to the
requirements of 4.7.
5.8 Ethylene oxide residue
Test according to the test method of ethylene oxide residue in GB/T 14233.1-
2008. Shall conform to the requirements of 4.8.
5.9 Biological evaluation
5.9.1 Cytotoxicity
Test according to the test method of leaching solution in GB/T 16886.5. Shall
conform to the requirements of 4.9.1.
5.9.2 Delayed type hypersensitivity
Test according to the test method in GB/T 16886.10. Shall conform to the
requirements of 4.9.2.
5.9.3 Intradermal stimulation test
The markings of the suction curette shall comply with the specifications of
Appendix A.
7.2 Instructions for use
7.2.1 There shall be instructions for use in the package.
7.2.2 The instructions shall be compiled in accordance with the requirements of
GB/T 9969.
7.2.3 The instruction for use shall contain the following.
a) Name and address of the manufacturer;
b) Product approval number and product standard number;
c) Scope of use and precautions of the product;
d) Product performance, manufacturing materials and possible side effects;
e) Requirements to ensure the correct and safe use of the suction curette,
as well as the requirements and precautions when used with other devices;
f) The measures and the precautions to be taken in case of accident occurred
during the use of the products;
g) Required contents and descriptions specified in the product standard.
8 Packaging, transportation and storage
8.1 Packaging
The packaging of the suction curette shall comply with the provisions of
Appendix A.
8.2 Transportation
Transportation requirements shall conform to the order contract.
8.3 Storage
The packaged suction curette shall be stored in a clean and well-ventilated
room at room temperature with relative humidity no more than 80% and no
corrosive gas.
8.4 Period of sterilization expiry
The suction curette sealed in the package shall be indicated with the period of
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Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.