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YY/T 0339-2019

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标准号码内文价格(元)第2步交付天数标准名称状态
YY/T 0339-2019 英文版 4339 购买 有增值税发票,[PDF]天数 <=5 呼吸道用吸引导管 有效

   
标准详细信息 YY/T 0339-2019; YY/T0339-2019
中文名称: 呼吸道用吸引导管
英文名称: Suction catheters for use in the respiratory tract
行业: 医药行业标准 (推荐)
中标分类: C46
国际标准分类: 11.040.10
字数估计: 30,389
发布日期: 2019-05-31
实施日期: 2020-06-01
起草单位: 上海市医疗器械检测所、江苏省医疗器械检验所、广州维力医疗器械股份有限公司
归口单位: 全国麻醉和呼吸设备标准化技术委员会(SAC/TC 116)
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

YY/T 0339-2019
Suction catheters for use in the respiratory tract
ICS 11.040.10
C46
中华人民共和国医药行业标准
代替YY0339-2009
呼吸道用吸引导管
(ISO 8836:2014,MOD)
2019-05-31发布
2020-06-01实施
国家药品监督管理局 发 布
目次
前言 Ⅲ
引言 Ⅴ
1 范围 1
2 规范性引用文件 1
3 术语和定义 2
4 开放式和封闭式吸引导管通用要求 5
4.1 风险管理 5
4.2 安全 5
5 开放式和封闭式吸引导管专用要求 5
5.1 规格和长度标识 5
5.2 尺寸 6
6 材料 6
7 设计 7
7.1 吸引导管管腔 7
7.2 吸引导管尖端 7
7.3 吸引导管接头 8
7.4 封闭式吸引导管附加要求 9
7.4.1 通用设计 9
7.4.2 封闭式吸引导管患者端转换接头和接头 10
7.4.3 保护套 10
7.4.4 封闭式吸引导管的真空控制装置 10
7.4.5 封闭式吸引导管的冲洗系统 10
7.4.6 T型盖帽 10
8 性能要求 11
8.1 连接牢固度 11
8.2 管身性能 11
8.3 真空控制装置性能 11
8.4 泄漏 11
8.5 气阻 12
8.6 射线不透性 12
9 以无菌形式提供的吸引导管的要求 12
9.1 无菌 12
9.2 无菌供应吸引导管的包装 12
10 标记 12
10.1 吸引导管的标记 12
10.2 符号的使用 14
10.3 独立包装的标签 14
10.4 货架/多单元包装的标签 14
附录A(资料性附录) 基本原理 15
附录B(规范性附录) 连接牢固度试验方法 18
附录C(规范性附录) 残留真空试验方法 19
附录D(规范性附录) 泄漏的测试方法 20
附录E(资料性附录) 风险评估的危害识别 21
参考文献 23
前言
本标准按照GB/T 1.1-2009给出的规则起草。
本标准代替YY0339-2009《呼吸道用吸引导管》,与YY0339-2009相比,除编辑性修改外主要
技术变化如下:
---增加了对封闭式吸引导管的要求(见7.4);
---修改了治疗呼吸机的要求(见8.4和8.5);
---修改了风险管理的要求(见4.1);
---根据ISO 8836,修正了图C.1中1、2的位置说明(见图C.1,YY0339-2009中图B.1)。
本标准使用重新起草法修改采用国际标准ISO 8836:2014《呼吸道用吸引导管》(英文版)。
本标准与ISO 8836:2014相比较,主要技术性差异如下:
---关于规范性引用文件,本标准作了具有技术性差异的调整,以适应我国的技术条件,调整的情
况集中反映在第2章“规范性引用文件”中,具体调整如下:
● 用国家标准GB/T 1962.1代替了国际标准ISO 594-1(见7.4.5);
● 用国家标准GB/T 1962.2代替了国际标准ISO 594-2(见7.4.5);
● 用国家标准GB/T 4999代替了国际标准ISO 4135:2001(见第3章);
● 用国家标准GB 9706.1代替了国际标准IEC 60601-1:2005(见10.2);
● 用国家标准GB/T 16273.1代替了国际标准ISO 7000(见10.2);
● 用国家标准GB/T 16886.1代替了国际标准ISO 10993-1(见6.1);
● 用国家标准GB/T 19633.1代替了国际标准ISO 11607-1(见9.2.2);
● 用国家标准GB/T 19633.2代替了国际标准ISO 11607-2(见9.2.2);
● 用行业标准YY/T 0316代替了国际标准ISO 14971:2007(见4.1.1);
● 用行业标准YY/T 0466.1代替了国际标准ISO 15223-1(见10.2);
● 用行业标准YY/T 0466.2代替了国际标准ISO 15223-2(见10.2);
● 用行业标准YY0636.1代替了国际标准ISO 10079-1(见7.3.1和7.3.6);
● 用行业标准YY0636.3代替了国际标准ISO 10079-3(见7.3.1和7.3.6);
● 用行业标准YY/T 1040.1代替了国际标准ISO 5356-1(见7.3.5、7.4.2.1和7.4.2.2)。
本标准与ISO 8836:2014相比较,作了如下编辑性修改:
---将ISO 8836:2014中与前一版本的主要差异说明移到本前言中;
---修正了ISO 8836:2014中的编辑性错误:
● 条款号7.3.6、7.3.7和7.3.8分别改为7.3.5、7.3.6和7.3.7;
● 将规范性引用的文件ISO 4135:2001从参考文献中移到第2章规范性引用文件中;
● 将非规范性引用的文件IEC 62366-1从第2章规范性引用文件中移到参考文献中,并用对
应的行业标准YY/T 1474代替。
替代的说明。
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。
本标准由国家药品监督管理局提出。
本标准由全国麻醉和呼吸设备标准化技术委员会(SAC/TC116)归口。
本标准起草单位:上海市医疗器械检测所、江苏省医疗器械检验所、广州维力医疗器械股份有限
公司。
本标准主要起草人:傅国庆、秦黎、黄开根、祝琰琤、陈涛。
引 言
本标准规定了呼吸道用吸引导管的尺寸和要求。同时包含了由柔韧材料制成的开放式吸引导管和
为帮助医疗人员在临床应用时更好地为特定患者选择最适宜的吸引导管,提出了针对吸引导管外
形和尺寸的描述方法。吸引导管的规格通过吸引导管的外径来决定。吸引导管的外径很重要,因为外
径决定吸引导管在与气管插管或气管切开插管共同使用时,二者是否能良好配合。
本标准中带星号(*)内容的解释参见附录A。
呼吸道用吸引导管
1 范围
本标准规定了由柔韧材料制成的,预期用于呼吸道的吸引导管的要求,包括开放式和封闭式的吸引
导管。
本标准适用于尖端呈弯形的吸引导管(如Coudé导管),或者是带有抽吸收集器的吸引导管,此类
本标准不适用于预期与可燃性麻醉气体或药剂、激光或电外科设备一起使用的吸引导管。
注:上呼吸道激光手术气道管理的指南文件参见ISO/T R11991[6]。
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 1962.1 注射器、注射针及其他医疗器械6%(鲁尔)圆锥接头 第1部分:通用要求
(GB/T 1962.1-2015,ISO 594-1:1986,IDT)
GB/T 1962.2 注射器、注射针及其他医疗器械6%(鲁尔)圆锥接头 第2部分:锁定接头
(GB/T 1962.2-2001,ISO 594-2:1998,IDT)
GB 9706.1 医用电气设备 第1部分:安全通用要求(GB 9706.1-2007,IEC 60601-1:1988,IDT)
GB/T 16273.1 设备用图形符号 第1部分:通用符号(GB/T 16273.1-2008,ISO 7000:2004,
NEQ)
GB/T 16886.1 医疗器械生物学评价 第1部分:风险管理过程中的评价与试验(GB/T 16886.1-
2011,ISO 10993-1:2009,IDT)
GB/T 19633.1 最终灭菌医疗器械包装 第1部分:材料、无菌屏障系统和包装系统的要求
(GB/T 19633.1-2015,ISO 11607-1:2006,IDT)
GB/T 19633.2 最终灭菌医疗器械包装 第2部分:成形、密封和装配过程的确认的要求
(GB/T 19633.2-2015,ISO 11607-2:2006,IDT)
IDT)
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
(YY/T 0466.1-2016,ISO 15223-1:2007,IDT)
YY/T 0466.2 医疗器械 用于医疗器械标签、标记和提供信息的符号 第2部分:符号的制订、
选择和确认(YY/T 0466.2-2015,ISO 15223-2:2010,IDT)
YY0636.1 医用吸引设备 第1部分:电动吸引设备 安全要求(YY0636.1-2008,ISO 10079-1:
1999,MOD)
YY0636.2 医用吸引设备 第2部分:人工驱动吸引设备(YY0636.2-2008,ISO 10079-2:1999,
IDT)
ISO 10079-3:1999,IDT)

YY/T 0339-2019
Suction catheters for use in the respiratory tract
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0339-2009
Respiratory catheter
(ISO 8836.2014, MOD)
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Content
Foreword III
Introduction V
1 range 1
2 Normative references 1
3 Terms and Definitions 2
4 General requirements for open and closed suction catheters 5
4.1 Risk Management 5
4.2 Security 5
5 Open and closed suction catheters special requirements 5
5.1 Specifications and length identification 5
5.2 Size 6
6 Material 6
7 Design 7
7.1 Attracting the catheter lumen 7
7.2 Attracting the catheter tip 7
7.3 Suction conduit connector 8
7.4 Closed suction catheters Additional requirements 9
7.4.1 Universal Design 9
7.4.2 Closed suction catheter patient end adapters and fittings 10
7.4.3 Protective cover 10
7.4.4 Vacuum control device for closed suction catheters 10
7.4.5 Flushing system for closed suction catheters 10
7.4.6 T-type cap 10
8 Performance requirements 11
8.1 Connection Fastness 11
8.2 Tube Performance 11
8.3 Vacuum control device performance 11
8.4 Leak 11
8.5 air resistance 12
8.6 Radiopacity 12
9 Requirements for suction catheters provided in sterile form 12
9.1 Sterility 12
9.2 Sterile supply of suction catheters 12
10 mark 12
10.1 Marking of the suction catheter 12
10.2 Use of symbols 14
10.3 Individually packaged labels 14
10.4 Labels for shelf/multi-unit packaging 14
Appendix A (informative) Basic Principles 15
Appendix B (Normative) Test Method for Connection Fastness 18
Appendix C (Normative Appendix) Residual Vacuum Test Method 19
Appendix D (Normative Appendix) Test Method for Leaks 20
Appendix E (informative) Hazard Identification for Risk Assessment 21
Reference 23
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0339-2009 "Attraction catheter for respiratory tract", compared with YY 0339-2009, except for editorial changes
The technical changes are as follows.
--- Increased requirements for closed suction catheters (see 7.4);
--- Revised the requirements for the treatment of ventilators (see 8.4 and 8.5);
--- Revised the requirements for risk management (see 4.1);
--- According to ISO 8836, the position description of 1, 2 in Figure C.1 is corrected (see Figure C.1, Figure B.1 in YY 0339-2009).
This standard uses the redrafting method to modify the international standard ISO 8836.2014 "Attraction catheter for respiratory tract" (English version).
The main technical differences between this standard and ISO 8836.2014 are as follows.
---About the normative reference documents, this standard has been technically adjusted to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory Citations”, and the specific adjustments are as follows.
● Replace the international standard ISO 594-1 with the national standard GB/T 1962.1 (see 7.4.5);
● Replace the international standard ISO 594-2 with the national standard GB/T 1962.2 (see 7.4.5);
● Replace the international standard IEC 60601-1.2005 with the national standard GB 9706.1 (see 10.2);
● Replace the international standard ISO 7000 with the national standard GB/T 16273.1 (see 10.2);
● Replace the international standard ISO 10993-1 with the national standard GB/T 16886.1 (see 6.1);
● Replace the international standard ISO 11607-1 with the national standard GB/T 19633.1 (see 9.2.2);
● Replace the international standard ISO 11607-2 with the national standard GB/T 19633.2 (see 9.2.2);
● Replace the international standard ISO 14971.2007 with the industry standard YY/T 0316 (see 4.1.1);
● Replace the international standard ISO 15223-1 with the industry standard YY/T 0466.1 (see 10.2);
● Replace the international standard ISO 15223-2 with the industry standard YY/T 0466.2 (see 10.2);
● Replace the international standard ISO 10079-1 with the industry standard YY 0636.1 (see 7.3.1 and 7.3.6);
● Replace the international standard ISO 10079-3 with the industry standard YY 0636.3 (see 7.3.1 and 7.3.6);
• Replace the international standard ISO 5356-1 with the industry standard YY/T 1040.1 (see 7.3.5, 7.4.2.1 and 7.4.2.2).
Compared with ISO 8836.2014, this standard has the following editorial changes.
--- Move the description of the main differences between ISO 8836.2014 and the previous version to this preface;
--- Fixed an editorial bug in ISO 8836.2014.
● Articles 7.3.6, 7.3.7 and 7.3.8 are changed to 7.3.5, 7.3.6 and 7.3.7 respectively;
• Move the normatively referenced document ISO 4135.2001 from the reference to the Chapter 2 normative reference;
● Move the non-normatively referenced document IEC 62366-1 from Chapter 2 normative references to the reference and use
Should be replaced by the industry standard YY/T 1474.
Alternative instructions.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This standard was drafted. Shanghai Medical Device Testing Institute, Jiangsu Medical Device Testing Institute, Guangzhou Weili Medical Devices Co., Ltd.
the company.
The main drafters of this standard. Fu Guoqing, Qin Li, Huang Kaigen, Zhu Yu, Chen Tao.
introduction
This standard specifies the size and requirements of the suction catheter for the respiratory tract. Also includes an open suction tube made of a flexible material and
In order to help medical personnel to better select the most suitable suction catheter for a specific patient in clinical application, it is proposed to attract the catheter outside the catheter.
Description of the shape and size. The size of the suction catheter is determined by the outer diameter of the suction catheter. The outer diameter of the suction catheter is important because
The diameter determines whether the suction catheter can be well matched when used in conjunction with an endotracheal tube or a tracheostomy tube.
See Appendix A for an explanation of the contents of the standard with an asterisk (*).
Respiratory catheter
1 Scope
This standard specifies the requirements for suction catheters made of flexible materials intended for the respiratory tract, including open and closed suction.
catheter.
This standard applies to suction catheters with a pointed tip (such as Coudé catheters) or suction catheters with suction collectors.
This standard does not apply to suction catheters intended for use with flammable anesthetic gases or pharmaceutical, laser or electrosurgical devices.
Note. Guidance documents for upper airway laser surgery airway management can be found in ISO /T R11991 [6].
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 1962.1 syringes, needles and other medical devices 6% (Ruhr) conical joints - Part 1. General requirements
(GB/T 1962.1-2015, ISO 594-1.1986, IDT)
GB/T 1962.2 syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints
(GB/T 1962.2-2001, ISO 594-2..1998, IDT)
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1.1988, IDT)
GB/T 16273.1 Graphical symbols for equipment - Part 1. General symbols (GB/T 16273.1-2008, ISO 7000.2004,
NEQ)
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
GB/T 19633.1 End-sterilized medical device packaging - Part 1. Requirements for materials, sterile barrier systems and packaging systems
(GB/T 19633.1-2015, ISO 11607-1.2006, IDT)
GB/T 19633.2 Packaging of terminally sterilized medical devices - Part 2. Requirements for confirmation of forming, sealing and assembly processes
(GB/T 19633.2-2015, ISO 11607-2.2006, IDT)
IDT)
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
(YY/T 0466.1-2016, ISO 15223-1.2007, IDT)
YY/T 0466.2 Medical devices for the labeling, marking and the provision of information for medical devices - Part 2. Development of symbols,
Selection and confirmation (YY/T 0466.2-2015, ISO 15223-2.2010, IDT)
YY 0636.1 Medical suction equipment - Part 1. Safety requirements for electric suction equipment (YY 0636.1-2008, ISO 10079-1.
1999, MOD)
YY 0636.2 Medical suction equipment Part 2. Manually driven suction equipment (YY 0636.2-2008, ISO 10079-2.1999,
IDT)
ISO 10079-3.1999, IDT)
YY/T 0339-2019
Suction catheters for use in the respiratory tract
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0339-2009
Respiratory catheter
(ISO 8836.2014, MOD)
2020-06-01 implementation
State Drug Administration issued
Content
Foreword III
Introduction V
1 range 1
2 Normative references 1
3 Terms and Definitions 2
4 General requirements for open and closed suction catheters 5
4.2 Security 5
5 Open and closed suction catheters special requirements 5
5.1 Specifications and length identification 5
5.2 Size 6
6 Material 6
7 Design 7
7.1 Attracting the catheter lumen 7
7.2 Attracting the catheter tip 7
7.3 Suction conduit connector 8
7.4.1 Universal Design 9
7.4.2 Closed suction catheter patient end adapters and fittings 10
7.4.3 Protective cover 10
7.4.4 Vacuum control device for closed suction catheters 10
7.4.5 Flushing system for closed suction catheters 10
7.4.6 T-type cap 10
8 Performance requirements 11
8.1 Connection Fastness 11
8.2 Tube Performance 11
8.4 Leak 11
8.5 air resistance 12
8.6 Radiopacity 12
9 Requirements for suction catheters provided in sterile form 12
9.1 Sterility 12
9.2 Sterile supply of suction catheters 12
10 mark 12
10.1 Marking of the suction catheter 12
10.2 Use of symbols 14
10.4 Labels for shelf/multi-unit packaging 14
Appendix A (informative) Basic Principles 15
Appendix B (Normative) Test Method for Connection Fastness 18
Appendix C (Normative Appendix) Residual Vacuum Test Method 19
Appendix D (Normative Appendix) Test Method for Leaks 20
Appendix E (informative) Hazard Identification for Risk Assessment 21
Reference 23
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
   
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