YY/T 0851-2023Medical thrombosis prophylaxis hosiery (English PDF)

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

3.9 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);

1 Scope

YY/T 0851 covers anti-embolism stockings, the graduated compression hosiery worn by immobile patients to reduce the risk of deep vein thrombosis. It sets the requirements such hosiery has to meet and the test methods that verify them, covering the pressure profile along the limb, how that profile is maintained through wear and laundering, the sizing that makes it fit, and the marking and information supplied. The pressure gradient is the whole mechanism: a stocking that grips harder at the thigh than the ankle impedes return flow instead of assisting it, which is worse than wearing nothing. It is distinct from the varicose vein hosiery of YY/T 0853, which serves a different indication at different pressures. The 2023 edition replaces YY/T 0851-2011.

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

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.