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YY/T 0979-2016 Related PDF English

YY/T 0979-2016 (YY/T0979-2016, YYT 0979-2016, YYT0979-2016) & related versions
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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 ......

BASIC DATA
Standard ID YY/T 0979-2016 (YY/T0979-2016)
Description (Translated English) Intra-uterine suction curettes for single use
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C36
Classification of International Standard 11.200
Word Count Estimation 11,156
Date of Issue 2016-03-23
Date of Implementation 2017-01-01
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Proposing organization State Administration of Food and Drug Administration
Issuing agency(ies) State Administration of Food and Drug Administration