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:2020-05-14  
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 0513.1-2019

标准搜索结果: 'YY/T 0513.1-2019'
标准号码内文价格(元)第2步交付天数标准名称状态
YY/T 0513.1-2019 英文版 1599 购买 有增值税发票,[PDF]天数 <=3 同种异体修复材料 第1部分:组织库基本要求 有效

   
标准编号: YY/T 0513.1-2019 (YY/T0513.1-2019)
中文名称: 同种异体修复材料 第1部分:组织库基本要求
英文名称: Allogeneic grafts -- Part 1: The basic requirements for tissue bank
行业: 医药行业标准 (推荐)
中标分类: C45
国际标准分类: 11.040.40
字数估计: 12,125
发布日期: 2019-10-23
实施日期: 2020-10-01
旧标准 (被替代): YY/T 0513.1-2009
引用标准: GB/T 16292; GB/T 16293; GB/T 16294; GB/T 19633.1; YY 0033; YY 0236; YY/T 0287
起草单位: 中国人民解放军总医院、山西省医用组织库、中国食品药品检定研究院
归口单位: 中国食品药品检定研究院
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 0513的本部分规定了组织库质量管理的基本要求,对同种异体组织库从知情同意或授权、捐献者适用性评估,以及组织产品的采集、加工、包装、标识和分发等全过程活动进行规定。本部分适用于同种异体组织库运行及其产品质量控制。

YY/T 0513.1-2019
Allogeneic grafts -- Part 1: The basic requirements for tissue bank
ICS 11.040.40
C45
中华人民共和国医药行业标准
代替YY/T 0513.1-2009
同种异体修复材料
第1部分:组织库基本要求
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 0513《同种异体修复材料》分为以下3个部分:
---第1部分:组织库基本要求;
---第2部分:深低温冷冻骨和冷冻干燥骨;
---第3部分:脱矿骨。
本部分为YY/T 0513的第1部分。
本部分按照GB/T 1.1-2009给出的规则起草。
本部分代替 YY/T 0513.1-2009《同种异体骨修复材料 第1部分:骨组织库基本要求》,与
YY/T 0513.1-2009相比,除编辑性修改外,主要技术变化如下:
---标准名称修改为《同种异体修复材料 第1部分:组织库基本要求》(见首页及标准正文的题
目,2009年版的首页及标准正文的题目);
---删除了引言部分(2009年版的引言);
---进一步明确了本部分的适用范围、以适应现阶段的管理法规,补充了适用的目前已有的产品类
别,并列为“注”对适用范围加以说明(见第1章,2009年版的第1章);
---增加了规范性引用文件的适用标准(见第2章,2009年版的第2章);
---修改了“骨组织库”术语为“组织库”并对其重新定义,增加了“供体、生产批、产品批”定义,以明
确基本概念(见第3章,2009年版的第3章);
---修改了“4骨组织库的组织形式和人员”为“4组织库的质量管理体系”,之后的所有涉及“骨组
织库”的名词均修改为“组织库”。以质量体系标准及法规为基础,明确并完善了质量体系的内
容;按照质量体系的要素,结合组织库的特点,重新罗列、规定了对各质量环节的要求。将“4.1
应设管理委员会”修改为“4.2.2组织库负责人”;增加了“4.2.3管理者代表”“4.3文件控制”
“4.4质量内审”(见第4章,2009年版的第4章);
---将“5生产和过程控制”条款分成“5基础设施控制”和“6生产过程控制”两个条款。在“5基础
设施控制”条款中对生产设施、检测设施、贮存设施的要求进行了完善和规范(见第5章和第6
章,2009年版第5章);
---在修改的“6生产过程控制”条款,增加了对生产各个环节进行管理及规范要求(见第6章,
2009年版的第5章);
---增加了“7质量控制”(见第7章);
---修改了“5.7骨组织获取的认可”条款为“8同种异体组织的获取”。删除了供体病史要求的
“5.8.8对活体来源上述组织应置于隔离保存箱内”,增加了“h)其他:根据不同组织的特性增加
相应的病史要求”;修改了“5.11供体测试要求”为“8.4.3血清学检测”,将原“注”的内容“如为
活存供体应加做乙型肝炎病毒核心抗体检验”提到正文的条件e);同时增加了“注:如果是非
活供体,可用由其组织材料的提取物或浸提液,选择经过验证的方法进行检测”;增加了组织获
取的环境要求和运输与接收要求(见第8章,2009年版的5.7);
---增加了“9组织的加工”条款(见第9章);
---修改了“6标签的控制”为“10标签与标识”,增加了“10.3产品说明书”的要求(见第10章,
2009年版的第6章);
---修改了“7包装的控制”为“11包装控制”,增加了“最终灭菌医疗器械的包装可参照GB/T 19633、
YY0236的要求”;删除了7.5包装内应有产品说明书的要求(见第11章,2009年版的第7章);
---修改了“9.2重新使用”为“14返库组织处置”(见第14章,见2009年版的9.2);
---增加了产品可追溯性要求内容(见第15章,2009年版的第9章);
---补充了产品召回程序的内容,完善了表述(见第17章,2009年版的第9章);
---修改了“9不良反应报告制度”为“18不良事件报告”,删除了其项下的亚条款。增加了 “医疗
器械不良事件监测和再评价管理办法”的引用(见第18章,见2009年版的第9章);
---更新了参考文献目录,补充了现行法规及新版美国组织库协会(AATB)的组织库标准(见参考
文献,2009年版参考文献);
---删除了“10骨组织库质量管理体系的保持”,相关内容合并到“7质量控制”(见第7章,2009年
版的第10章)。
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。
本部分由中国食品药品检定研究院归口。
本部分起草单位:中国人民解放军总医院、山西省医用组织库、中国食品药品检定研究院。
本部分主要起草人:卢世璧、郭全义、赵亚平、徐丽明、彭江、许文静、邵安良、赵师充、鲜海、冯晓明、
奚廷斐。
同种异体修复材料
第1部分:组织库基本要求
1 范围
YY/T 0513的本部分规定了组织库质量管理的基本要求,对同种异体组织库从知情同意或授权、
捐献者适用性评估,以及组织产品的采集、加工、包装、标识和分发等全过程活动进行规定。
本部分适用于同种异体组织库运行及其产品质量控制。
注:组织库产品主要包括同种异体的骨组织(冷冻干燥骨、深低温冷冻骨)、骨关节及附着组织(如软骨、半月板等)、
同种异体软组织(肌腱/韧带、神经、膜组织、皮肤等)和上述组织衍生成分(如脱矿骨、脱细胞组织)等。
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 16292 医药工业洁净室(区)悬浮粒子的测试方法
GB/T 16293 医药工业洁净室(区)浮游菌的测试方法
GB/T 16294 医药工业洁净室(区)沉降菌的测试方法
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
YY0236 药品包装用复合膜(通则)
YY/T 0287 医疗器械 质量管理体系 用于法规的要求
中华人民共和国药典(2015版)
3 术语和定义
下列术语和定义适用于本文件。
3.1
组织库 Tissuebank
从事筛选供体、获取、加工、检验、贮存、分发组织制品,用于临床移植/植入治疗的机构。
3.2
提供同种异体组织的捐赠者。
3.3
生产批 lot
来源于同一供体,在同一时间内和同一生产线生产出的,具有同一性质和质量的一定数量的产品。
3.4
产品批 batch
来源于同一供体,在同一加工周期内和同一工艺条件下连续生产出的,具有同一性质和质量的一定
数量的产品。

YY/T 0513.1-2019
Allogeneic grafts-Part 1. The basic requirements for tissue bank
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
Replaces YY/T 0513.1-2009
Allogeneic repair material
Part 1. Basic requirements for organization libraries
Published on October 23,.2019
2020-10-01 implementation
Published by the State Drug Administration
Foreword
YY/T 0513 `` Allogeneic Repair Materials '' is divided into the following 3 parts.
--- Part 1. Basic requirements for the organization library;
--- Part 2. Deep hypothermic frozen bone and freeze-dried bone;
--- Part 3. Demineralized bone.
This part is the first part of YY/T 0513.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY/T 0513.1-2009 "Allogeneic bone repair materials Part 1. Basic requirements for bone tissue bank", and
Compared with YY/T 0513.1-2009, in addition to editorial changes, the main technical changes are as follows.
--- The standard name was changed to "Allogeneic Repair Materials Part 1. Basic Requirements for Tissue Banks" (see the title of the homepage and the standard text)
Title, title of the.2009 version of the front page and standard text);
--- Removed the introduction (2009 introduction);
--- Further clarified the scope of application of this section to adapt to current management regulations, and supplemented the applicable existing product categories
In addition, it is listed as a "note" to explain the scope of application (see Chapter 1, Chapter 1 of the.2009 edition);
--- Added applicable standards for normative references (see Chapter 2, Chapter 2 of the.2009 edition);
--- Revised the term "bone tissue bank" to "tissue bank" and redefined it, and added the definition of "donor, production batch, product batch" to clarify
Confirm the basic concepts (see Chapter 3, Chapter 3 of the.2009 edition);
--- Modified the "4 bone tissue bank organization form and personnel" to "4 tissue bank quality management system", all subsequent ones involving "bone group
The term "weaving library" has been revised to "organization library". Based on the quality system standards and regulations, the internals of the quality system have been clarified and improved.
Content; according to the elements of the quality system, combined with the characteristics of the organizational library, re-listed and stipulated the requirements for each quality link. "4.1
"Management Committee shall be established" was revised to "4.2.2 Organizing Bank Manager"; "4.2.3 Manager Representative" and "4.3 Document Control" were added
"4.4 Quality Internal Audit" (see Chapter 4, Chapter 4 of the.2009 edition);
--- Divide the "5 production and process control" clauses into "5 infrastructure control" and "6 production process control" clauses. Based on "5
The “facility control” clause has refined and standardized the requirements for production facilities, testing facilities, and storage facilities (see Chapters 5 and 6
(Chapter 5,.2009 edition);
--- In the revised "6 Production Process Control" clause, management and specification requirements for all aspects of production have been added (see Chapter 6,
Chapter 5 of the.2009 edition);
--- Added "7 Quality Control" (see Chapter 7);
--- Modified the "5.7 Recognition of Bone Tissue Acquisition" to "8 Acquisition of Allogeneic Tissue". Removed donor medical history requirements
"5.8.8 The above-mentioned tissues of living sources shall be placed in a separate storage box", adding "h) Others. according to the characteristics of different tissues
Corresponding Medical History Requirements "; revised" 5.11 Donor Test Requirements "to" 8.4.3 Serological Tests ", replacing the content of the original" Note "with"
"Living donors should be tested for hepatitis B virus core antibodies" mentioned in the text of condition e); at the same time, "Note. if not
Live donors can be tested with validated methods using extracts or extracts from their tissue materials "; increased tissue yield
Environmental requirements and transport and reception requirements (see Chapter 8, 5.7 of the.2009 edition);
--- Added "9 Organizational Processing" clauses (see Chapter 9);
--- Modified the "6 tags control" to "10 tags and labels" and added the requirements of "10.3 Product Manual" (see Chapter 10,
Chapter 6 of the.2009 edition);
--- Amended the "7 packaging control" to "11 packaging control", added "the final sterilized medical device packaging can refer to GB/T 19633,
Requirement of YY 0236 "; Removed the requirement that there should be product instructions in the 7.5 package (see Chapter 11, Chapter 7 of the.2009 edition);
--- Modified "9.2 Reuse" to "14 Disposal Organizations for Disposal" (see Chapter 14, see 9.2 in.2009)
--- Added the content of product traceability requirements (see Chapter 15, Chapter 9 of the.2009 edition);
--- Added the content of the product recall procedure and improved the presentation (see Chapter 17, Chapter 9 of the.2009 edition);
--- Amended the "9 adverse reaction report system" to "18 adverse event reports", deleted the sub-items under it. Added "Medical
Citations for the management of device adverse event monitoring and re-evaluation "(see Chapter 18, see Chapter 9 of the.2009 edition);
--- Updated the bibliography, supplemented the current regulations and the new version of the American Organizational Bank Association (AATB) Organizational Library Standard (see References
Literature,.2009 edition references);
--- Deleted "Maintenance of 10 Bone Tissue Bank Quality Management System", and related content was merged into "7 Quality Control" (see Chapter 7,.2009
Chapter 10).
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 the China Food and Drug Administration.
This section was drafted. General Hospital of the Chinese People's Liberation Army, Shanxi Medical Organization Bank, China Food and Drug Testing Institute.
The main drafters of this section. Lu Shizhang, Guo Quanyi, Zhao Yaping, Xu Liming, Peng Jiang, Xu Wenjing, Shao Anliang, Zhao Shichong, Xian Hai, Feng Xiaoming,
Wu Tingfei.
Allogeneic repair material
Part 1. Basic requirements for organization libraries
1 Scope
This part of YY/T 0513 specifies the basic requirements for the quality management of the tissue bank.It requires informed consent or authorization,
Donor applicability assessment, and organization of product collection, processing, packaging, labeling, and distribution of the whole process of activities are regulated.
Note. Tissue bank products mainly include allogeneic bone tissue (freeze-dried bone, deep hypothermic frozen bone), bone joints and attached tissue (such as cartilage, meniscus, etc.),
Allogeneic soft tissue (tendon/ligament, nerve, membrane tissue, skin, etc.) and the above-mentioned tissue-derived components (such as demineralized bone, acellular tissue), etc.
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 16292 Test method for suspended particles in clean room (area) of pharmaceutical industry
GB/T 16293 Test method for plankton in clean room (area) of pharmaceutical industry
GB/T 16294 Test method for sedimentary bacteria in clean room (area) of pharmaceutical industry
GB/T 19633.1 Packaging of final sterilized medical devices. Part 1. Requirements for materials, sterile barrier systems and packaging systems
YY 0236 Compound film for pharmaceutical packaging (general rules)
YY/T 0287 Medical device quality management system for regulatory requirements
Pharmacopoeia of the People's Republic of China (2015 Edition)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Tissuebank
Institutions engaged in screening donors, obtaining, processing, inspecting, storing, and distributing tissue products for clinical transplantation/implantation treatment.
3.2
Donors who provide allogeneic tissues.
3.3
Production lot
A certain number of products from the same donor, produced at the same time and on the same production line, with the same properties and quality.
3.4
Product batch
Produced from the same donor and continuously produced in the same processing cycle and under the same process conditions.
Number of products.
   
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 | 账号:35050168730700000955 | 账户名称:宁德梧三商贸有限公司 | 大额行号(非必须):105403500207 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