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YY/T 0853-2011

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标准编号: YY/T 0853-2011 (YY/T0853-2011)
中文名称: 医用静脉曲张压缩袜
英文名称: Medical compression hosiery for varices
行业: 医药行业标准 (推荐)
中标分类: C31
国际标准分类: 11.040.20
字数估计: 29,292
发布日期: 2011-12-31
实施日期: 2013-06-01
引用标准: YY/T 0466.1; GB/T 6529-2008; GB/T 8629-2001; GB/T 13634; GB/T 8685-2008
采用标准: ENV 12718-2001, MOD
起草单位: 山东省医疗器械产品质量检验中心、绍兴好士德医用品有限公司
归口单位: 国家食品药品监督管理局济南医疗器械质量监督检验中心
标准依据: 国家食品药品监督管理局公告2011年第106号;行业标准备案公告2013年第6号(总第162号)
提出机构: 国家食品药品监督管理局
发布机构: 国家食品药品监督管理局
范围: 本标准规定了由天然纤维或合成纤维和合成弹性纤维针织而成的医用静脉曲张压缩袜(包括订制袜)的要求和试验方法。本标准适用于作为医疗器械治疗腿部静脉和/或淋巴疾病的压缩袜(以下简称“压缩袜, )。本标准没有给出压缩袜制造方面的要求。

YY/T 0853-2011
Medical compression hosiery for varices
ICS 11.040.20
C31
中华人民共和国医药行业标准
医用静脉曲张压缩袜
2011-12-31发布
2013-06-01实施
国家食品药品监督管理局 发 布
前言
本标准按照GB/T 1.1-2009给出的规则起草。
本标准修改采用ENV12718:2001《医用压缩袜》。本标准与ENV12718:2001的主要技术性差异
在于:
---取消了CclA压缩等级,标准名称改为《医用静脉曲张压缩袜》;
---取消了附录A(资料性附录)压缩袜的制造方法以及第3章中相应的术语;
---以附录A的形式推荐了持久性评价试验方法;
---取消了附录D(资料性附录)压缩力试验方法实例。
本标准由国家食品药品监督管理局提出。
本标准由国家食品药品监督管理局济南医疗器械质量监督检验中心归口。
本标准由山东省医疗器械产品质量检验中心、绍兴好士德医用品有限公司负责起草,中国针织工业
协会参加起草。
本标准主要起草人:吴平、王金红、孙海鹏、胡修元、王智。
引 言
持久性(压缩袜在模拟的重复洗涤和穿戴程序后保持其公称压缩力的能力)是压缩袜的重要性能。
压缩袜的持久性可通过选择结构材料和制造方法来得到保证。EN12718-2001的附录A中提供了相
关材料和制造方面的信息。本标准的附录A则推荐了持久性试验方法。
医用静脉曲张压缩袜
1 范围
本标准规定了由天然纤维或合成纤维和合成弹性纤维针织而成的医用静脉曲张压缩袜 (包括订制
袜)的要求和试验方法。本标准适用于作为医疗器械治疗腿部静脉和/或淋巴疾病的压缩袜(以下简称
“压缩袜”)。本标准没有给出压缩袜制造方面的要求。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
YY/T 0466.1 医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分:通用要求
GB/T 6529-2008 纺织品 调湿和试验用标准大气
GB/T 8629-2001 纺织品 试验用家庭洗涤和干燥程序
GB/T 13634 单轴试验机检验用标准测力仪的校准
GB/T 8685-2008 纺织品 维护标签规范 符号法
3 术语和定义
下列术语和定义适用于本文件。
3.1
压缩力 compression
压缩袜对腿部施加的压力。
3.2
压缩力等级 compressionclasses
压缩袜按对踝部所产生的压缩力进行分级。
3.3
订制袜 custommadehosiery
专门为一个病人制造的适合其腿形尺寸的压缩袜。
3.4
持久性 durability
压缩袜在模拟的重复洗涤和穿戴程序后保持其公称压缩力的能力。
3.5
伸展性 extensibility
在本标准规定的试验程序下,压缩袜能沿着腿的横向(周向)或纵向(腿的长度方向)伸展的最大程
度,用占未受力时压缩袜规格的百分比表示。
3.6
横列线圈 course
针织物中线圈在横向排列的一行。

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
医用静脉曲张压缩袜
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
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)
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.
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.
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
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
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.
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;
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.
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 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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