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YY/T 1921-2023 English PDF

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US$239.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1921-2023: Closed type copper-bearing contraceptive intrauterine devices
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1921-2023	239	Add to Cart	3 days	Closed type copper-bearing contraceptive intrauterine devices	Valid

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Basic data

Standard ID: YY/T 1921-2023 (YY/T1921-2023)
Description (Translated English): Closed type copper-bearing contraceptive intrauterine devices
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C36
Classification of International Standard: 11.200
Word Count Estimation: 12,138
Date of Issue: 2023-09-05
Date of Implementation: 2024-09-15
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the composition and type, requirements, information provided by the manufacturer, packaging and expiry date of closed-loop copper-containing intrauterine devices, and describes the corresponding test methods. This standard applies to closed-loop copper-containing intrauterine devices and their inserters, which are placed in the uterine cavity of women for contraceptive purposes.

YY/T 1921-2023: Closed type copper-bearing contraceptive intrauterine 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 Closed-loop copper intrauterine device Published on 2023-09-05 Implemented on 2024-09-15 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. Release of this document The Agency 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 Equipment Co., Ltd., Shanghai Medical Suture Needle Factory Co., Ltd., Shanghai Medical Equipment Co., Ltd. Inspection Institute, Yantai Family Planning Pharmaceutical Equipment Co., Ltd., Henan Yakang Pharmaceutical Co., Ltd., Jiangsu Medical Device Inspection Institute. The main drafters of this document. Sun Xinhan, Duan Zhuo, Yao Tianping, Tian Yunxia, Zhong Xiuyun, Zheng Dixin, Yin Fengxia, Qian Xinyi, Gu Xiaoyu, Wang Weiguang, Chen Zheng, Li Haiqi. Closed-loop copper intrauterine device

1 Scope

This document specifies the composition, type, requirements, and information provided by the manufacturer of the closed-loop copper-containing intrauterine device (hereinafter referred to as "IUD"). information, packaging and expiry dates, and the corresponding test methods are described. This document applies to closed-loop copper-containing intrauterine devices and their inserters, which are placed in the uterine cavity of women for contraceptive purposes.

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 YY/T 0149 Test method for corrosion resistance of stainless steel medical instruments YY/T 0334-2022 General requirements for silicone rubber surgical implants YY/T 0640-2016 General requirements for passive surgical implants YY/T 1404 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 closed type Connected end to end, they form a closed structure similar to the shape of a uterine cavity. 3.2 corrosion resistancecorrosionresistance The ability of metallic materials to resist the corrosive and damaging effects of the surrounding medium. 3.3 Deformation recovery abilityvisco-elasticproperty The IUD can roughly return to its original shape after deformation. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1921-2023_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1921-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1921-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1921-2023_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.