YY/T 0851-2023 Medical thrombosis prophylaxis hosiery
1 Scope
This document specifies requirements and gives test methods for medical thrombosis prophylaxis hosiery knitted from threads made of natural fibres or synthetic fibres.
This document is applicable to thrombosis prophylaxis hosiery which is used as a medical device for the prevention of venous thrombosis.
This document is not applicable to custom made hosiery.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 6529-2008 Textiles - Standard atmospheres for conditioning and testing
GB/T 8629-2017 Textiles - Domestic washing and drying procedures for textile testing
GB/T 13634 Metallic materials - Calibration of force-proving instruments used for the verification of uniaxial testing machines
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: general requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
compression
pressure exerted on the leg by the thrombosis prophylaxis hosiery (3.8)
3.2
durability
ability of thrombosis prophylaxis hosiery (3.8) to retain its designated compression
3.3
extensibility
maximum degree, expressed as a percentage of the unloaded size of the thrombosis prophylaxis hosiery (3.8), in which the thrombosis prophylaxis hosiery (3.8) can be stretched in the transverse (circumferential) or in the longitudinal direction (lengthwise direction of the leg) under the test procedure specified in this document
3.4
practical elongation
elongation of hosiery in the circumferential direction with the hosiery on the leg, expressed as a percentage of the difference between the designated and non-stretched girths to the non-stretched girth
3.5
pressure profile
representation of the compression (3.1) exerted by the thrombosis prophylaxis hosiery (3.8) along the leg
3.6
residual pressure
compression (3.1) at a certain point expressed as a percentage of the compression (3.1) at the ankle
3.7
standard size hosiery
thrombosis prophylaxis hosiery (3.8) manufactured in the types and sizes specified in this document
3.8
medical thrombosis prophylaxis hosiery
hosiery which when worn on the leg exerts graduated compression on the leg surface and is intended to reduce the incidence of venous thrombosis
Note: It is abbreviated in this document to “thrombosis prophylaxis hosiery”.
4 Compression
The compression of the thrombosis prophylaxis hosiery on the ankle shall be labeled in one of the following two ways:
Where it is labeled by range, the compression shall range from 17.5 hPa to 24 hPa (13 mmHg to 18 mmHg);
Where it is labeled by nominal value, the tolerance shall not exceed ±4.0 hPa (3 mmHg).
The compression shall be measured in accordance with Annex A.
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Compression
5 Nominal dimensions and standard sizes
6 Heel
7 Ease of examination
8 Seams
9 Edges
10 Achievement of pressure profile
11 Mechanical properties
12 Packaging
13 Marking and instructions for use
Annex A (Normative) Method for testing compressive properties of thrombosis prophylaxis hosiery
Annex B (Normative) Method of determination of extensibility of thrombosis prophylaxis hosiery
Annex C (Normative) Method of determination of durability of thrombosis prophylaxis hosiery
Bibliography
