YY/T 0851-2023 English PDF

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YY/T 0851-2023: Medical thrombosis prophylaxis hosiery
Status: Valid

YY/T 0851: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0851-2023	519	Add to Cart	5 days	Medical thrombosis prophylaxis hosiery	Valid
YY/T 0851-2011	959	Add to Cart	5 days	Medical thrombosis prophylaxis hosiery	Obsolete

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Basic data

Standard ID: YY/T 0851-2023 (YY/T0851-2023)
Description (Translated English): Medical thrombosis prophylaxis hosiery
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.040
Word Count Estimation: 26,241
Date of Issue: 2023-09-05
Date of Implementation: 2024-09-15
Older Standard (superseded by this standard): YY/T 0851-2011
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the requirements and test methods for medical anti-thrombotic socks knitted from natural and/or synthetic fibers. This standard applies to anti-thrombotic stockings used as medical devices to prevent venous thrombosis. This document does not apply to custom socks.

YY/T 0851-2023: Medical thrombosis prophylaxis hosiery

---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 11.040 CCSC31 Pharmaceutical Industry Standards of the People's Republic of China Replace YY/T 0851-2011 Medical anti-thrombosis socks 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. This document replaces YY/T 0851-2011 "Medical Anti-thrombotic Stockings". Compared with YY/T 0851-2011, except for structural adjustment and editing In addition to the modifications, the main technical changes are as follows. a) The normative reference documents have been changed (see Chapter 2, Chapter 2 of the.2011 edition); b) Delete the terms "elastic material" and "standard specification anti-thrombus stockings tolerance" (see 3.3 and 3.9 of the.2011 edition); change the terminology "Medical anti-thrombotic socks" (see 3.8,.2011 version of 3.10); c) Changed the requirements for sock edges (see Chapter 9, Chapter 9 of the.2011 edition); d) Changed “Stretchability” (see 11.1,.2011 version of 11.1); e) Changed the “proportional pressure” (see 11.3,.2011 version of 11.3); f) Delete the “product name” in the logo of anti-thrombotic socks (see 13.2 of the.2011 version); g) Changed the packaging mark (see 13.3,.2011 version of 13.3); h) The washing procedure has been changed (see A.4.1, B.4.1 of the.2011 version); i) Added test gauge length formula (see Appendix A.4.7); j) Changed the "Measurement method of stretchability of anti-thrombotic socks" (see Appendix B, Appendix C of the.2011 version); k) The “anti-embolus socks durability test method” has been changed (see Appendix C, Appendix A of the.2011 version). 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 Shandong Medical Device and Drug Packaging Inspection Institute. This document was drafted by. Shandong Institute of Medical Device and Drug Packaging Inspection, Zhende Medical Supplies Co., Ltd., Jiadenuo (Part 1) Hai) Medical Equipment Co., Ltd., Maid Trading (Shanghai) Co., Ltd., Shandong Nomei Economic and Trade Co., Ltd., Capital Medical University Affiliated Beijing Chaoyang Hospital. The main drafters of this document. Guo Shiyu, Sun Guangyu, Zhang Lifeng, Zhu Yanyan, Li Zhiqiang, Wei Hailong, and Li Chunmin. The previous versions of this document and the documents it replaces are as follows. ---First released in.2011 as YY/T 0851-2011; ---This is the first revision.

Introduction

Durability is an important feature of anti-thrombotic socks. The long-lasting performance of anti-embolism stockings can be ensured through the choice of construction materials and manufacturing methods. certificate. Appendix C of this document gives the durability test method. Medical anti-thrombotic socks

1 Scope

This document specifies the requirements and test methods for medical anti-thrombotic stockings knitted from natural and/or synthetic fibers. This document applies to anti-thrombotic stockings used as medical devices to prevent venous thrombosis. This document does not apply to custom socks.

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 6529-2008 Standard atmosphere for humidity conditioning and testing of textiles GB/T 8629-2017 Home washing and drying procedures for textile testing GB/T 13634 Calibration of standard force measuring instrument for inspection of uniaxial testing machines for metallic materials YY/T 0466.1 Medical devices Symbols used for labeling, marking and providing information on medical devices Part 1.General requirements

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 compression forcecompression The pressure exerted on the legs by anti-thrombotic socks (3.8). 3.2 Durability The ability of anti-embolism socks (3.8) to maintain their labeled compression properties. 3.3 extensibility Under the test procedures specified in this document, anti-thrombotic socks (3.8) can stretch along the transverse (circumferential) or longitudinal (lengthwise direction of the leg) of the leg. Maximum extent, expressed as a percentage of the specification of anti-thrombotic socks (3.8) when no force is applied. 3.4 actual extension ratepracticalelongation The elongation of socks worn on the legs in the transverse direction, expressed as the difference between the marked circumference and the unstretched circumference as a percentage of the unstretched circumference. 3.5 Compression force system pressureprofile Representation of the compression force (3.1) exerted by anti-thrombotic socks (3.8) in the direction of the leg. 3.6 Residualpressure The compression force (3.1) at a point expressed as a percentage of the compression force (3.1) at the ankle. ......

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