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YY/T 1884-2023 English PDF

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YY/T 1884-2023: Fixed type copper-bearing intra-uterine contraceptive devices
Status: Valid
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YY/T 1884-2023English379 Add to Cart 4 days [Need to translate] Fixed type copper-bearing intra-uterine contraceptive devices Valid YY/T 1884-2023

PDF similar to YY/T 1884-2023


Standard similar to YY/T 1884-2023

YY/T 1783   YY/T 1777   YY/T 1797   YY/T 1850   YY/T 1921   

Basic data

Standard ID YY/T 1884-2023 (YY/T1884-2023)
Description (Translated English) Fixed type copper-bearing intra-uterine contraceptive devices
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C36
Classification of International Standard 11.200
Word Count Estimation 18,178
Date of Issue 2023-06-20
Date of Implementation 2024-07-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the composition and basic dimensions, requirements, test methods, information provided by the manufacturer, packaging and expiration date of fixed copper-containing IUDs. This standard applies to fixed copper-containing intrauterine devices, which are fixed in women's uterine cavity and used for contraception.

YY/T 1884-2023: Fixed type copper-bearing intra-uterine contraceptive devices

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.200 CCSC36 Pharmaceutical Industry Standards of the People's Republic of China Fixed copper intrauterine device Published on 2023-06-20 2024-07-01 Implementation Released by the State Drug Administration

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Family Planning Devices (SAC/TC169). This document was drafted by. Wuhan Weimin Medical Devices Co., Ltd., Shanghai Medical Device Inspection and Research Institute, Tianjin Hejie Medical Devices Equipment Co., Ltd., Chongqing Medical Equipment Quality Inspection Center. The main drafters of this document. Sun Xinhan, Yao Tianping, Wei Bo, Meng Mingjiang, Pan Ning, Qian Xinyi, Qin Na, and Fan Sijie. Fixed copper intrauterine device

1 Scope

This document specifies the composition and basic dimensions, requirements, test methods, information provided by the manufacturer, and packaging of fixed copper intrauterine devices. and expiry date. This document applies to fixed copper-containing intrauterine devices, which are fixed in the uterine cavity of women and used for contraception.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB/T 4240 stainless steel wire GB/T 4340.1 Vickers hardness test of metallic materials Part 1.Test methods GB 11236-2021 Technical requirements and test methods for copper-containing intrauterine devices GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing during risk management process GB/T 16886.13-2017 Biological evaluation of medical devices Part 13.Qualification and analysis of degradation products of polymer medical devices Quantitative YY/T 0640-2016 General requirements for passive surgical implants YY/T 1404-2016 Technical requirements and test methods for copper used in copper-containing intrauterine devices YY/T 1471-2016 Technical requirements and test methods for indomethacin-containing silicone rubber for copper-containing intrauterine devices Pharmacopoeia of the People's Republic of China (2020 edition)

3 Terms and definitions

The following terms and definitions as defined in GB 11236-2021 apply to this document. 3.1 fixedtype The instrument is suspended in the uterine cavity by being fixed to the myometrium with non-absorbable sutures. 3.2 indomethacin A non-steroidal anti-inflammatory drug loaded on a copper-containing intrauterine device (IUD), which has anti-inflammatory and analgesic effects. 3.3 biodegradablepolymer Polymer materials that can be degraded by microorganisms or secretions in organisms under the action of enzymes or chemical substances within a certain period of time. 3.4 There is no hook force after the needle tip is loaded with external force.

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