YY/T 0853-2011 (YY/T0853-2011, YYT 0853-2011, YYT0853-2011)
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Medical compression hosiery for varices
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YY/T 0853-2011
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Medical compression hosiery for varices
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YY/T 0853-2024
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Newer version: YY/T 0853-2024 Standards related to: YY/T 0853-2024
| Standard ID | YY/T 0853-2011 (YY/T0853-2011) | | 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 | 11.040.20 | | Word Count Estimation | 29,282 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | YY/T 0466.1; GB/T 6529-2008; GB/T 8629-2001; GB/T 13634; GB/T 8685-2008 | | Adopted Standard | ENV 12718-2001, MOD | | Drafting Organization | Shandong Province Quality Inspection Center of Medical Devices | | Administrative Organization | Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies from natural or synthetic fibers and synthetic fibers knitted elastic compression stockings made of medical varicose veins (including custom socks) requirements and test methods. This standard applies to treat leg veins as a medical device and/or lymphatic disease compression stockings (hereinafter referred to as "compression stockings) This standard does not give compression socks manufacturing requirements. | YY/T 0853-2011
YY
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Medical compression hosiery for varices
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 1, 2013
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Compressive force classes ... 7
5 Nominal size and standard specification ... 8
6 Heel ... 14
7 Seam ... 14
8 Hosiery edge ... 14
9 Implementation of pressure profile ... 14
10 Mechanical performance ... 15
11 Package ... 16
12 Marks and instructions for use ... 16
Appendix A ... 18
Appendix B ... 21
Appendix C ... 36
References ... 37
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard adopted and modified ENV 12718.2001 “Medical compression
hosiery”. The main technical differences between this Standard and ENV
12718.2001 are as follows.
- Deleted Ccl A compression level; the standard’s name was modified to
“Medical compression hosiery for varices”;
- Deleted “Production methods of compression hosiery” in Appendix A
(informative) and corresponding terms in Clause 3;
- Recommended evaluation method for durability test in Appendix A.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of Jinan Medical Device Quality
Supervision and Inspection Center of State Food and Drug Administration.
Main drafting organizations of this Standard. Shandong Medical Device Quality
Supervision and Inspection Center and Shaoxing Haoshide Medical Products
Co., Ltd.
Drafting organization of this Standard. China Knitting Industry Association.
Main drafters of this Standard. Wu Ping, Wang Jinhong, Sun Haipeng, Hu
Xiuyuan and Wang Zhi.
Introduction
Durability (the ability of maintaining its nominal compressive force of
compression hosiery after repeated washing and dressing procedure in
simulation) is an important performance of compression hosiery. Durability of
compression hosiery shall be guaranteed by selection of structural material and
manufacturing method. Appendix A of EN 12718-2001 provides relevant
information about material and manufacturing method. Appendix A of this
Standard recommends the guideline of persistence test.
Medical compression hosiery for varices
1 Scope
This Standard specifies the requirements and test methods for medical
compression hosiery for varices (including custom made hosiery) that are
knitted of natural or synthetic fibers and synthetic elastic fibers. This Standard
applies to compression hosiery as medical device for leg veins and / or
lymphatic disease (hereinafter referred to as the “compression hosiery”).
This Standard does not provide manufacturing requirements for compression
hosiery.
2 Normative references
The following referenced documents are indispensable for the application 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.
YY/T 0466.1 Devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1. General requirements (YY/T
0466.1-2009, ISO 15223-1.2007, IDT)
GB 6529-2008 Textiles - Standard atmospheres for conditioning and testing
(ISO 139.2005, MOD)
GB/T 8629-2001 Textiles - Domestic washing and drying procedures for
textile testing (eqv ISO 6330-2001)
GB/T 13634 Calibration of force-proving instruments used for the verification
of uniaxial testing machines (GB/T 13634-2008, ISO 376-2004, IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Compression
The pressure that is applied on legs by compression hosiery.
3.2 Compression classes
The classes that are conducted for compression hosiery according to the
compressive force generated by ankle.
3.3 Custom made hosiery
The compression hosiery that is specially made for a patient and suits his/her
leg size.
3.4 Durability
The ability of maintaining its nominal compressive force of compression hosiery,
after repeated washing and dressing procedure in simulation.
3.5 Extensibility
The maximum extent of compression hosiery stretching to leg laterally
(circumferentially) or vertically (leg length direction) under the test procedures
specified in this Standard, represented by percentage accounting for
compression hosiery specifications in un-stressing condition.
3.6 Course
A row of coils that are arranged transversely in fabric.
3.7 Medical compression hosiery for varices
The compression hosiery that applies a certain of compressive force on legs in
a bottom-up and gradual decreasing way, so as to treat leg veins and / or
lymphatic disease.
Note. It is referred as “compression hosiery” for short in this Standard.
3.8 Practical elongation
The elongation in the transverse direction of hosiery on legs, represented by
percentage of the difference between the marked circumference and the un-
stretching circumference accounting for the un-stretching circumference.
3.9 Pressure profile
The representation of compressive force of compression hosiery, applied along
leg direction.
3.10 Residual pressure
The compressive force at some point, represented by the percentage
5 Nominal size and standard specification
5.1 General principle
Compression hosiery specification of human leg length and circumference shall
be marked at the measuring points given in Figure 1 and Table 2.
5.2 Length measurement
When necessary, each length shall be measured based on the codes given in
Table 3.
5.3 Circumference measurement
When necessary, each circumference shall be measured based on the codes
given in Table 4.
5.4 Specification
Note. For easy use of compression hosiery and reference for test methods stipulated in
this Standard, this specification is based on ankle circumference (cB).
5.4.1 Length
Except custom made hosiery, the length and length range shall be selected in
Table 5.
5.4.2 Circumference
Except custom made hosiery, the circumference and circumference range shall
be selected in Table 6.
5.5 Type and specification mark of compression hosiery
Compression hosiery shall comply with the type codes in Table 7 (except
custom made hosiery), and shall be marked by the following three pairs of
numbers that represent leg sizes of which compression hosiery applies to.
- According to ankle circumference range given in Table 6;
- According to ankle circumference range of compression hosiery’s upper
end given in Table 6;
- According to length range given in Table 5.
When the values of each measurement point in the middle are in the same
vertical column in Table 6, or the minimum circumference and the maximum
10 Mechanical performance
10.1 Extensibility
The compression hosiery shall be able to transversely extend to at least 120%
at measuring point B and farthest measuring points (D, F and G, if applicable),
and longitudinally at least 30% at measuring point B and farthest measuring
point (D, F and G, if applicable).
Conduct the test according to Appendix C.
10.2 Practical rate of extension
The practical rate of extension at measuring points of B, B1, C, D, E, F and G
shall not be less than 15% and not be greater than 140%.
Conduct the test according to Appendix B.
10.3 Residual pressure
In order to prevent irregular pressure profile along with leg length, it shall
measure the pressure at measuring points B, B1, C, D, E, F and G (if applicable)
(shown in B.2.4).
It shall calculate the residual pressure at each measuring point of B1, C, D, E,
F and G (if applicable) (shown in B.2.5).
The residual pressure of compression hosiery (pressure profile) shall be within
the range determined by given values in Table 8.
Note. If it is measured at measuring points D and G or G (if applicable), no matter the
residual pressure is calculated by the maximum circumference at measuring point B and
the pressure measured by the minimum circumference given by D, F and G of
manufacturer OR it is calculated by the minimum circumference of measuring point B and
the maximum cir...
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