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YY/T 0853-2024 English PDF

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YY/T 0853-2024: Medical compression hosiery for varices
Status: Valid

YY/T 0853: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0853-2024English619 Add to Cart 5 days [Need to translate] Medical compression hosiery for varices Valid YY/T 0853-2024
YY/T 0853-2011English150 Add to Cart 0--9 seconds. Auto-delivery Medical compression hosiery for varices Valid YY/T 0853-2011

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Basic data

Standard ID YY/T 0853-2024 (YY/T0853-2024)
Description (Translated English) Medical compression hosiery for varices
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.040
Word Count Estimation 30,36
Date of Issue 2024-02-07
Date of Implementation 2025-03-01
Older Standard (superseded by this standard) YY/T 0853-2011
Issuing agency(ies) State Drug Administration
Summary This standard specifies the requirements for medical varicose vein compression stockings (including custom-made stockings) knitted from natural and/or synthetic fibers and describes the corresponding test methods. This document applies to medical varicose vein compression stockings.

YY/T 0853-2024: Medical compression hosiery for varices

---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 Replaces YY/T 0853-2011 Medical varicose vein compression stockings Released on 2024-02-07 2025-03-01 Implementation The State Drug Administration issued

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document replaces YY/T 0853-2011 "Medical Compression Socks for Varicose Veins". Compared with YY/T 0853-2011, except for structural adjustments and In addition to editorial changes, the main technical changes are as follows. a) The normative references have been changed (see Chapter 2, Chapter 2 of the.2011 edition); b) The definition of "medical varicose vein compression stockings" has been changed (see 3.7, 3.7 of the.2011 edition); the term "standard specification compression stockings" has been deleted. Tolerances” (see 3.13 of the.2011 edition); c) Changed the requirements for sock edges (see Chapter 8, Chapter 8 of the.2011 edition); d) "Extensibility" has been changed (see 10.1, 10.1 of the.2011 edition); e) Changed "Persistence" (see 10.4, 10.4 of the.2011 edition); f) The packaging has been changed (see Chapter 11, Chapter 11 of the.2011 edition); g) The packaging mark has been changed (see 12.3, 12.3 of the.2011 edition); h) "Installation test sample" has been changed (see A.4.7, B.4.7 of the.2011 edition); i) Changed the “Compression Stocking Durability Test Method” and “Washing Procedure”, and added accelerated test condition 3 (see Appendix C,.2011 Edition) Appendix A). Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of Shandong Medical Device and Drug Packaging Inspection Institute. This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Zhende Medical Supplies Co., Ltd., Cardinal Health (Shanghai Shanghai) Medical Equipment Co., Ltd., Myidea Trading (Shanghai) Co., Ltd., Shandong Nomi Trading Co., Ltd., Beijing Chaoyang Medical Equipment Co., Ltd., Capital Medical University Hospital. The main drafters of this document are. Liang Jinkui, Chen Hongjian, Zhang Lifeng, Qiu Shuang, Li Zhiqiang, Wei Hailong and Li Chunmin. The previous versions of this document and the documents it replaces are as follows. ---First published in.2011 as YY/T 0853-2011; ---This is the first revision.

Introduction

Durability is an important property of compression stockings. The durability of compression stockings can be ensured by selecting structural materials and manufacturing methods. Appendix C of this document gives the durability test method. Medical varicose vein compression stockings

1 Scope

This document specifies the requirements for medical varicose vein compression stockings (including custom stockings) knitted from natural and/or synthetic fibers. The corresponding test methods are described. This document applies to medical varicose vein compression stockings (hereinafter referred to as "compression stockings").

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 6529-2008 Standard atmospheres for conditioning and testing textiles GB/T 8629-2017 Domestic washing and drying procedures for textile testing GB/T 8685 Textile Care Labeling Standard Symbols GB/T 13634 Calibration of standard dynamometers for uniaxial testing machines of metallic materials YY/T 0466.1 Medical devices Symbols for labelling, 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 The pressure exerted on the legs by compression stockings (3.7). 3.2 compression classes Compression stockings (3.7) are classified according to the compression force (3.1) they produce on the ankle. 3.3 Custom made hosiery Compression stockings (3.7) are made specifically for a patient and are tailored to the size of his or her leg. 3.4 Durability The ability of a compression stocking (3.7) to maintain its declared compression properties after a simulated repeated washing and wearing cycle. 3.5 Extensibility The maximum extension of a compression stocking (3.7) in the transverse (circumferential) or longitudinal (lengthwise) direction of the leg under the test procedures specified in this document is. The degree of compression is expressed as a percentage of the size of the compression stocking (3.7) when not under load. 3.6 Row coil course A row of stitches in a knitted fabric arranged in the horizontal direction.

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