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YY/T 0853-2011Medical compression hosiery for varices (English PDF)

医用静脉曲张压缩袜

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY/T 0853-2011 is the English-translated version of 医用静脉曲张压缩袜.

YY/T 0853-2011 is the Chinese standard "Medical compression hosiery for varices". Its scope clause reads: 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.

Its clauses include terms and definitions; compressive force classes; nominal size and standard specification; heel; seam; hosiery edge; implementation of pressure profile; mechanical performance; package; marks and instructions for use.

It was issued by the China Food and Drug Administration on DECEMBER 31, 2011 and took effect on JUNE 1, 2013.

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Document preview — YY/T 0853-2011

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword3
  • Introduction4
  • 1 Scope5
  • 2 Normative references5
  • 3 Terms and definitions5
  • 4 Compressive force classes7
  • 5 Nominal size and standard specification8
  • 6 Heel14
  • 7 Seam14
  • 8 Hosiery edge14
  • 9 Implementation of pressure profile14
  • 10 Mechanical performance15
  • 11 Package16
  • 12 Marks and instructions for use16
  • Appendix A18
  • Appendix B21
  • Appendix C36
  • References37

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.

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.

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: […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 37 pages — is available in the English PDF.

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