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YY/T 0616.5-2019

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YY/T 0616.5-2019 英文版 1729 购买 有增值税发票,[PDF]天数 <=3 一次性使用医用手套 第5部分:抗化学品渗透持续接触试验方法 有效

   
标准编号: YY/T 0616.5-2019 (YY/T0616.5-2019)
中文名称: 一次性使用医用手套 第5部分:抗化学品渗透持续接触试验方法
英文名称: Medical gloves for single use -- Part 5: Test method for permeation of chemicals under conditions of continuous contact
行业: 医药行业标准 (推荐)
中标分类: C48
国际标准分类: 11.140.01
字数估计: 13,186
发布日期: 2019-10-23
实施日期: 2020-10-01
引用标准: GB/T 2941; GB/T 6682
起草单位: 山东省医疗器械产品质量检验中心、石家庄鸿锐集团有限公司、蓝帆医疗股份有限公司
归口单位: 山东省医疗器械产品质量检验中心
标准依据: 国家药品监督管理局公告2019年第84号
提出机构: 国家药品监督管理局
发布机构: 国家药品监督管理局
范围: YY/T 0616的本部分规定了在持续接触条件下,一次性使用医用手套材料抗液体化学品渗透的试验条件、试验程序及结果报告。本部分适用于对一次性使用医用手套进行抗化学品渗透性能评价。

YY/T 0616.5-2019
Medical gloves for single use -- Part 5: Test method for permeation of chemicals under conditions of continuous contact
ICS 11.140.01
C48
中华人民共和国医药行业标准
一次性使用医用手套 第5部分:
抗化学品渗透 持续接触试验方法
2019-10-23发布
2020-10-01实施
国家药品监督管理局 发 布
前言
YY/T 0616《一次性使用医用手套》拟分为以下几部分:
---第1部分:生物学评价要求与试验;
---第2部分:测定货架寿命的要求和试验;
---第3部分:用仓贮中的成品手套确定实际时间失效日期的方法;
---第4部分:抗穿刺试验方法;
---第5部分:抗化学品渗透 持续接触试验方法;
本部分为YY/T 0616的第5部分。
本部分按照GB/T 1.1-2009给出的规则起草。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别这些专利的责任。
本部分由国家药品监督管理局提出。
本部分由山东省医疗器械产品质量检验中心归口。
本部分起草单位:山东省医疗器械产品质量检验中心、石家庄鸿锐集团有限公司、蓝帆医疗股份有
限公司。
本部分主要起草人:张丽梅、郭利娟、孙兴霞、刘贵喜、刘伟、吴长岩、孙钰朋。
引 言
医护人员在工作中,可能会接触到一些对健康人群产生危害的化学品(如各种消毒剂、化学灭菌剂、
化学药品等),对人体造成各类程度的伤害,如皮肤刺激和灼伤之类的急性创伤,以及像癌症这样的慢性
变异性疾病。为避免此类危害,医护人员需要佩戴具备相应防护性能的产品(如医用手套),以达到有效
防护的目的。
化学品对防护产品材料的透过,通常包含两种形式:穿透(penetration)和渗透(permeation),二者
机理完全不同。本部分的渗透试验是建立在渗透机理上(见4.1)。穿透即物质在非分子水平上通过医
用手套材料中空隙(包括接合面缝隙、不完整的密封和/或材料本身的孔、洞等)的运动。穿透不需要状
态发生改变,即固体化学品以固态通过材料的空隙,液体以液态通过,气体以气态通过。
目前,欧美国家对此类声称有防护功能的医用手套,均要求注明防护类别(如化疗用)或防护级别
(如1级)。本部分建立的一套医用手套抗化学品渗透测试装置及一个标准试验方法,可用来评价医用
手套对液体化学品阻抗性能,从而更好地指导医护人员选择适宜产品,进行有效防护。
本部分建立医用手套材料抗化学品的通用试验方法,将给出具体应用,即测定医用手套材料抗化疗
药物渗透性能试验方法。
一次性使用医用手套 第5部分:
抗化学品渗透 持续接触试验方法
1 范围
YY/T 0616的本部分规定了在持续接触条件下,一次性使用医用手套材料抗液体化学品渗透的试
验条件、试验程序及结果报告。
本部分适用于对一次性使用医用手套进行抗化学品渗透性能评价。
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。
GB/T 2941 橡胶物理试验方法试样制备和调节通用程序
GB/T 6682 分析实验室用水规格和试验方法
3 术语和定义
下列术语和定义适用于本文件。
3.1
突破检测时间 breakthroughdetectiontime
从开始接触试验化学品到首次检测到试验化学品的所经历的时间。
注:突破检测时间取决于方法的灵敏度。
3.2
标准突破时间 standardizedbreakthroughtime
渗透速率达到0.1μg/(cm2·min)的时间。
3.3
稳态渗透 steady-statepermeation
当化学品连续接触且所有影响的渗透因素已达到平衡时,突破后形成的恒速渗透。
3.4
收集介质 colectionmedium
一种可吸收、吸附、溶解、悬浮或捕获试验化学品,且不影响渗透的化学品检测的液体。
3.5
累积渗透 cumulativepermeation
从材料开始接触试验化学品到某一特定时间,渗透过特定面积手套材料的化学品的总量。
3.6
降解 degradation
手套材料的一个或多个性能发生有害的变化。
注:通常最关注的是物理性能的变化(如膨胀等)。

YY/T 0616.5-2019
Medical gloves for single use-Part 5. Test method for permeation of chemicals under conditions of continuous contact
ICS 11.140.01
C48
People's Republic of China Pharmaceutical Industry Standard
Single-use medical gloves. Part 5.
Test method for continuous penetration resistance against chemicals
Published on October 23,.2019
2020-10-01 implementation
Published by the State Drug Administration
Foreword
YY/T 0616 `` Disposable Medical Gloves '' is intended to be divided into the following parts.
--- Part 1. Biological evaluation requirements and tests;
--- Part 2. Requirements and tests for determining shelf life;
--- Part 3. Method for determining the actual time expiry date with the finished gloves in storage;
--- Part 4. Puncture resistance test method;
--- Part 5. Test method for continuous exposure to chemical penetration;
This part is Part 5 of YY/T 0616.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This section is proposed by the State Drug Administration.
This section is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center.
This section was drafted by. Shandong Medical Device Product Quality Inspection Center, Shijiazhuang Hongrui Group Co., Ltd., Lanfan Medical Co., Ltd.
Limited company.
The main drafters of this section. Zhang Limei, Guo Lijuan, Sun Xingxia, Liu Guixi, Liu Wei, Wu Changyan, and Sun Yupeng.
introduction
Medical workers may be exposed to chemicals that are harmful to healthy people at work (such as various disinfectants, chemical sterilants,
Chemicals, etc.), causing various levels of harm to the human body, such as acute trauma such as skin irritation and burns, and chronic diseases such as cancer
Variant disease. To avoid such hazards, medical personnel need to wear products with appropriate protective properties (such as medical gloves) to achieve effective
The purpose of protection.
The penetration of chemicals into protective product materials usually includes two forms. penetration and permeation, both of which
The mechanism is completely different. The permeation tests in this section are based on the permeation mechanism (see 4.1). Penetration is when a substance passes through the medicine at a non-molecular level
Use the movement of the voids in the glove material (including joint gaps, incomplete seals, and/or holes, holes, etc. in the material itself). Needless to penetrate
The state changes, that is, the solid chemical passes through the voids of the material in a solid state, the liquid passes in a liquid state, and the gas passes in a gas state.
At present, European and American countries require such protective gloves to indicate the type of protection (such as chemotherapy) or protection level
(Such as level 1). A set of chemical resistance test equipment for medical gloves and a standard test method established in this section can be used to evaluate medical
The resistance of gloves to liquid chemicals can better guide medical staff to choose suitable products for effective protection.
This section establishes a general test method for chemical resistance of medical glove materials.It will give a specific application, that is, determine the resistance of medical glove materials to chemotherapy.
Test method for drug permeability.
Single-use medical gloves. Part 5.
Test method for continuous penetration resistance against chemicals
1 Scope
This part of YY/T 0616 specifies the test of resistance to the penetration of liquid chemicals by disposable medical gloves under continuous exposure
Test conditions, test procedures and results report.
This section applies to the evaluation of chemical penetration resistance of disposable medical gloves.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 2941 Rubber physical test method General procedure for sample preparation and adjustment
GB/T 6682 Analytical laboratory water specifications and test methods
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Breakthrough detection time
The time elapsed from the start of exposure to the test chemical to the first detection of the test chemical.
Note. The breakthrough detection time depends on the sensitivity of the method.
3.2
Standardizedbreakthroughtime
Time when the permeation rate reaches 0.1 μg/(cm2 · min).
3.3
Steady-state permeation
When chemicals are in continuous contact and all influencing infiltration factors have reached equilibrium, a constant velocity infiltration is formed after the breakthrough.
3.4
Collection medium colectionmedium
A liquid that can absorb, adsorb, dissolve, suspend, or capture test chemicals without affecting the detection of penetrating chemicals.
3.5
Cumulative permeation
The total amount of chemicals that penetrated a specific area of glove material from the time the material began to contact the test chemicals to a specific time.
3.6
Degradation
Note. Usually the most concerned is the change of physical properties (such as swelling, etc.).
   
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