9秒发货/有发票 梧三标准英文版 优质技术翻译  数据库收录:159759 最近更新:2020-03-18  
支付宝/对公账号 首页   询价  购买流程  英文样品 公司简介   购物车

YY/T 0506.8-2019

标准搜索结果: 'YY/T 0506.8-2019'
标准号码内文价格(元)第2步交付天数标准名称状态
YY/T 0506.8-2019 英文版 2659 购买 有增值税发票,[PDF]天数 <=4 病人、医护人员和器械用手术单、手术衣和洁净服 第8部分:产品专用要求 有效

   
标准详细信息 YY/T 0506.8-2019; YY/T0506.8-2019
中文名称: 病人、医护人员和器械用手术单、手术衣和洁净服 第8部分:产品专用要求
英文名称: Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 8: Special requirements for products
行业: 医药行业标准 (推荐)
中标分类: C46
国际标准分类: 11.040
字数估计: 18,132
发布日期: 2019-07-24
实施日期: 2020-08-01
起草单位: 山东省医疗器械产品质量检验中心、振德医疗用品股份有限公司、山东康力医疗器械科技有限公司、稳健医疗用品股份有限公司
归口单位: 山东省医疗器械产品质量检验中心
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 0506.8-2019
Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 8: Special requirements for products
ICS 11.040
C46
中华人民共和国医药行业标准
病人、医护人员和器械用手术单、手术衣和
洁净服 第8部分:产品专用要求
2019-07-24发布
2020-08-01实施
国家药品监督管理局 发 布
目次
前言 Ⅲ
引言 Ⅳ
1 范围 1
2 规范性引用文件 1
3 术语和定义 1
4 通用要求 2
4.1 灭菌要求 2
4.1.1 无菌保证 2
4.1.2 环氧乙烷残留量 2
4.2 生物学要求 2
5 手术单设计要求 2
5.1 器械手术单 2
5.1.1 性能 2
5.1.2 结构设计 2
5.1.3 折叠要求 2
5.2 病人手术单 3
5.2.1 关键区域的划分 3
5.2.2 一般性能 3
5.2.3 覆盖能力 3
5.2.4 手术洞口相关组件 4
5.2.5 液体控制组件-液体吸收层(若有) 4
5.2.6 液体控制组件-液体收集袋(若有) 4
5.2.7 其他器械固定装置 5
5.2.8 折叠要求 5
5.2.9 透气性 5
6 手术衣 5
6.1 关键区域的划分 5
6.2 性能 5
6.3 规格 6
6.4 透气性 6
6.5 折叠 6
6.6 系带连接牢固性 6
6.7 重复性手术衣抗洗涤寿命 6
7 洁净服 6
7.1 型式 6
7.2 性能 6
8 取样 7
附录A(资料性附录) 手术单标示示例 8
附录B(资料性附录) 手术衣常见型式和推荐规格 10
附录C(资料性附录) 推荐的手术衣折叠方法 11
附录D(资料性附录) 在产品上裁取试验样品的规则 12
参考文献 14
图1 手术单关键区域与非关键区域图示 3
图2 手术衣关键区域与非关键区域图示 5
图3 典型的洁净服型式 7
图A.1 剖腹产手术单型式及尺寸标注(示例) 8
图A.2 腹腔手术单关键区域标识及尺寸标注(示例) 9
图B.1 手术衣型式和规格示例图 10
图C.1 推荐的手术衣折叠方法 11
表A.1 剖腹产手术单尺寸(示例) 8
表A.2 腹腔手术单尺寸(示例) 9
表B.1 推荐的手术衣规格 10
前言
YY/T 0506《病人、医护人员和器械用手术单、手术衣和洁净服》,由以下部分组成:
---第1部分:制造商、处理厂和产品的通用要求;
---第2部分:性能要求和试验方法;
---第4部分:干态落絮试验方法;
---第5部分:阻干态微生物穿透试验方法;
---第6部分:阻湿态微生物穿透试验方法;
---第7部分:洁净度-微生物试验方法;
---第8部分:产品专用要求。
本部分为YY/T 0506的第8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、振德医疗用品股份有限公司、山东康力医疗
器械科技有限公司、稳健医疗用品股份有限公司。
本部分主要起草人:张庆、鲁建国、陈署光、何倩、师广波、潘自强、刘壮、王欢、艾冲冲。
YY/T 0506系列标准规定了病人、医护人员和器械用一次性使用和重复性使用覆盖物(即手术衣、
手术单和洁净服)的要求,这些产品作为医疗器械预期在创伤性手术中防止传染原在病人和医务人员之
间传播。
在已发布的YY/T 0506系列标准实施过程中发现,YY/T 0506.2-2016规定的要求偏重于面料的
要求,符合YY/T 0506.2-2016的手术单、手术衣和洁净服不足以能证明满足临床的相关要求,如,对
结构、接缝、液体控制等特殊要求。因此,有必要开发YY/T 0506的本部分。
YY/T 0506本部分的预期目的包括:
---在YY/T 0506的第1部分和第2部分的基础上进一步规范手术单、手术衣和洁净服的要求;
---为YY/T 0506手术单、手术衣和洁净服的生产企业在设计产品时提供进一步的指南。
YY/T 0506的本部分规定的手术单的要求适用于但不限于:通用手术单、神经外科手术单、胸腔手
术单、腹腔手术单、泌尿外科手术单、妇科手术单、眼内手术单、头颈外科手术单、骨科矫形手术单、四肢
手术单、关节置换手术单、心血管手术单、心血管介入手术单、剖腹产手术单、膀胱镜手术单、甲状腺手术
单、乳腺手术单、臀部手术单、髋关节手术单、脊柱手术单、肩关节手术单、疝气手术单、取石手术单等。
病人、医护人员和器械用手术单、手术衣和
洁净服 第8部分:产品专用要求
1 范围
YY/T 0506的本部分规定了病人、医护人员和器械用手术单、手术衣和洁净服的专用要求。
本部分适用于对净化程度要求较高、需要病人全身覆盖的手术用手术单、手术衣和洁净服。
手术室用手术单、手术衣和洁净服的临床要求取决于手术创面的开放程度和洁净手术室的净化级别。
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 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 16886.7 医疗器械生物学评价 第7部分:环氧乙烷灭菌残留量
YY/T 0506.1-2005 病人、医护人员和器械用手术单、手术衣和洁净服 第1部分:制造厂、处理
厂和产品的通用要求
YY/T 0506.2-2016 病人、医护人员和器械用手术单、手术衣和洁净服 第2部分:性能要求和
YY/T 0615.1 标示“无菌”医疗器械的要求 第1部分:最终灭菌医疗器械的要求
YY0852-2011 一次性使用无菌手术膜
3 术语和定义
YY/T 0506.1-2005和YY/T 0506.2-2016界定的以及下列术语和定义适用于本文件。
3.1
正常使用工作状态 workingconditionfornormal-use
手术单处于按其使用方式覆盖或固定在手术台或模拟手术台的病人身上的状态。
注:试验时,可以使用模拟手术台和模拟病人。
3.2
其长2000mm±100mm、宽550mm±50mm、高500mm~1120mm(可调)用以模拟相应手术
的手术台。
3.3
模拟病人 simulativepatient
体重70kg±5kg,身高为170cm~175cm的健康自愿者或能形成规定体位的人体模型或人体模
拟物。

YY/T 0506.8-2019
Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 8. Special requirements for products
ICS 11.040
C46
People's Republic of China Pharmaceutical Industry Standard
Surgical sheets, surgical gowns, and patients, medical personnel, and equipment
Clean clothes Part 8. Product specific requirements
Surgicaldrapes, gownsandcleanairsuitsforpatients,clinicalstaffand
equipment-Part 8. Specialrequirementsforproducts
Published on.2019-07-24
2020-08-01 implementation
State Drug Administration issued
Content
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 General requirements 2
4.1 Sterilization Requirements 2
4.1.1 Aseptic Guarantee 2
4.1.2 Ethylene oxide residue 2
4.2 Biological requirements 2
5 surgical single design requirements 2
5.1 Device Surgical Sheet 2
5.1.1 Performance 2
5.1.2 Structural Design 2
5.1.3 Folding requirements 2
5.2 Patient Surgical Sheet 3
5.2.1 Division of key areas 3
5.2.2 General performance 3
5.2.3 Covering capacity 3
5.2.4 Surgical Portal Related Components 4
5.2.5 Liquid Control Assembly - Liquid Absorbing Layer (if any) 4
5.2.6 Liquid Control Assembly - Liquid Collection Bag (if available) 4
5.2.7 Other equipment fixtures 5
5.2.8 Folding requirement 5
5.2.9 Gas permeability 5
6 Surgical gown 5
6.1 Division of key areas 5
6.2 Performance 5
6.3 Size 6
6.4 Breathability 6
6.5 folding 6
6.6 strap connection robustness 6
6.7 Repetitive surgical gowns resistant to washing life 6
7 clean clothes 6
7.1 Type 6
7.2 Performance 6
8 sampling 7
Appendix A (informative) Surgical order labeling example 8
Appendix B (informative) Common types of surgical gowns and recommended specifications 10
Appendix C (informative) Recommended surgical clothing folding method 11
Appendix D (informative) Rules 12 for the determination of test samples on products
Reference 14
Figure 1 Operational key and non-critical areas Figure 3
Figure 2 Key and non-critical areas of the surgical gown Figure 5
Figure 3 Typical clean clothing type 7
Figure A.1 Caesarean section single type and dimensioning (example) 8
Figure A.2 Identification and dimensioning of key areas for abdominal surgery (example) 9
Figure B.1 Surgical gown type and specification example Figure 10
Figure C.1 Recommended surgical gown folding method 11
Table A.1 Caesarean section size (example) 8
Table A.2 Single size for abdominal surgery (example) 9
Table B.1 Recommended Surgical Gown Size 10
Foreword
YY/T 0506 "Surgical, medical, and surgical gowns for patients, medical personnel, and equipment" consists of the following.
--- Part 1. General requirements for manufacturers, treatment plants and products;
--- Part 2. Performance requirements and test methods;
---Part 4. Dry drop test method;
---Part 6. Test method for penetration resistance of microorganisms;
---Part 7. Cleanliness - Microbiological test methods;
--- Part 8. Product-specific requirements.
This part is part 8 of YY/T 0506.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
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 part is proposed by the State Drug Administration.
This part is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center.
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Zhende Medical Products Co., Ltd., Shandong Kangli Medical
The main drafters of this section. Zhang Qing, Lu Jianguo, Chen Fuguang, He Qian, Shi Guangbo, Pan Ziqiang, Liu Zhuang, Wang Huan, Ai Chongchong.
introduction
The YY/T 0506 series of standards specifies disposable and reusable coverings for patients, healthcare personnel and devices (ie surgical gowns,
Requirements for surgical orders and cleansing suits, these products as medical devices are expected to prevent infectious agents in patients and medical staff during traumatic surgery
Spread between.
During the implementation of the published YY/T 0506 series of standards, it was found that the requirements specified in YY/T 0506.2-2016 were biased towards fabrics.
Requirements, surgical orders, surgical gowns and cleansing suits in accordance with YY/T 0506.2-2016 are not sufficient to demonstrate compliance with clinical requirements, eg,
Special requirements such as structure, joints, and liquid control. Therefore, it is necessary to develop this part of YY/T 0506.
The intended purpose of this part of YY/T 0506 includes.
--- Manufacturers of YY/T 0506 surgical, surgical, and cleansing garments provide further guidance when designing products.
Note. For more information on the products included in this section, see YY/T 0506.1.
The requirements for the surgical procedure specified in this section of YY/T 0506 apply to, but are not limited to, general surgical procedures, neurosurgery procedures, and thoracic hand
Surgery, abdominal surgery, urological surgery, gynecological surgery, intraocular surgery, head and neck surgery, orthopedic surgery, limbs
Surgical procedures, joint replacement surgery, cardiovascular surgery, cardiovascular interventional procedures, caesarean section, cystoscopy, thyroid surgery
Single, breast surgery, hip surgery, hip surgery, spinal surgery, shoulder surgery, hernia surgery, stone surgery, etc.
Surgical sheets, surgical gowns, and patients, medical personnel, and equipment
Clean clothes Part 8. Product specific requirements
1 Scope
This section applies to surgical drapes, surgical gowns and cleansing suits that require a high level of cleansing and require full coverage of the patient.
Note. The surgical procedures specified in this section do not include single-use and repetitive surgical procedures for small surgery with small wound opening and low surgical purification level.
The clinical requirements for operating rooms, surgical gowns, and cleansing suits in the operating room depend on the degree of openness of the surgical wound and the level of cleansing of the clean operating room.
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 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
GB/T 16886.7 Biological evaluation of medical devices - Part 7. Resin residues
YY/T 0506.1-2005 Surgical sheets, surgical gowns and cleansing suits for patients, medical staff and instruments - Part 1. Manufacturing, processing
YY/T 0506.2-2016 Surgical sheets, surgical gowns and cleansing suits for patients, medical staff and equipment - Part 2. Performance requirements and
experiment method
YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for terminally sterilized medical devices
YY 0852-2011 Disposable sterile surgical film
3 Terms and definitions
The following terms and definitions as defined in YY/T 0506.1-2005 and YY/T 0506.2-2016 apply to this document.
3.1
Normal use working condition workingconditionfornormal-use
The surgical sheet is in a state of being covered or fixed to the patient on the operating table or the simulated operating table according to its use.
3.2
Simulated operating table simpleoperatingtable
Its length is.2000mm±100mm, width is 550mm±50mm, height is 500mm~1120mm (adjustable) to simulate the corresponding operation
Operating table.
3.3
Simulated patient
A healthy volunteer with a body weight of 70kg ± 5kg and a height of 170cm ~ 175cm or a human body model or a human body model capable of forming a prescribed body position
Imitation.
YY/T 0506.8-2019
ICS 11.040
C46
People's Republic of China Pharmaceutical Industry Standard
Surgical sheets, surgical gowns, and patients, medical personnel, and equipment
Clean clothes Part 8. Product specific requirements
Surgicaldrapes, gownsandcleanairsuitsforpatients,clinicalstaffand
equipment-Part 8. Specialrequirementsforproducts
Published on.2019-07-24
2020-08-01 implementation
Content
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 General requirements 2
4.1 Sterilization Requirements 2
4.1.1 Aseptic Guarantee 2
4.2 Biological requirements 2
5 surgical single design requirements 2
5.1 Device Surgical Sheet 2
5.1.1 Performance 2
5.1.2 Structural Design 2
5.1.3 Folding requirements 2
5.2 Patient Surgical Sheet 3
5.2.1 Division of key areas 3
5.2.2 General performance 3
5.2.4 Surgical Portal Related Components 4
5.2.5 Liquid Control Assembly - Liquid Absorbing Layer (if any) 4
5.2.6 Liquid Control Assembly - Liquid Collection Bag (if available) 4
5.2.7 Other equipment fixtures 5
5.2.8 Folding requirement 5
5.2.9 Gas permeability 5
6 Surgical gown 5
6.1 Division of key areas 5
6.2 Performance 5
6.4 Breathability 6
6.5 folding 6
6.6 strap connection robustness 6
6.7 Repetitive surgical gowns resistant to washing life 6
7 clean clothes 6
7.1 Type 6
7.2 Performance 6
8 sampling 7
Appendix A (informative) Surgical order labeling example 8
Appendix C (informative) Recommended surgical clothing folding method 11
Appendix D (informative) Rules 12 for the determination of test samples on products
Reference 14
Figure 1 Operational key and non-critical areas Figure 3
Figure 2 Key and non-critical areas of the surgical gown Figure 5
Figure 3 Typical clean clothing type 7
Figure A.1 Caesarean section single type and dimensioning (example) 8
Figure A.2 Identification and dimensioning of key areas for abdominal surgery (example) 9
Figure B.1 Surgical gown type and specification example Figure 10
Table A.1 Caesarean section size (example) 8
Table A.2 Single size for abdominal surgery (example) 9
Table B.1 Recommended Surgical Gown Size 10
Foreword
YY/T 0506 "Surgical, medical, and surgical gowns for patients, medical personnel, and equipment" consists of the following.
--- Part 1. General requirements for manufacturers, treatment plants and products;
--- Part 2. Performance requirements and test methods;
---Part 4. Dry drop test method;
---Part 5. Test method for resistance to dry microbial penetration;
   
宁德梧三商贸有限公司 | 纳税人识别号:91350900MA32WE2Q2X | 营业执照:营业执照证书
点击联络我们 联系电邮郑文锐销售经理: Sales@gb-gbt.cn | Sales@ChineseStandard.net | 电话郑经理: 18059327808 | 增值税普通发票 / 增值税专用发票样品
对公开户银行:中国建设银行古田支行 | 账户名称:宁德梧三商贸有限公司 | 账号:35050168730700000955 对公银行账号证书
翻译支持:全资母公司新加坡场测亚洲公司(https://www.ChineseStandard.net 卖欧美后再内销)
网站备案许可:闽ICP备19012676号 http://www.beian.miit.gov.cn
隐私   ·  优质产品   ·  退款政策   ·  公平交易   ·  关于我们