FDA医疗器械质量体系手册第三章设计控制.doc
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1、FDA医疗器械质量体系手册 第三章 设计控制3. Design Controls3 设 计 控 制INTRODUCTION引言 Coverage覆 盖 范 围QUALITY SYSTEM质 量 体 系 Personnel Training人员 培 训DESIGN AND DEVELOPMENT PLANNING设 计 和 开 发 计 划 Interface沟 通 Structure of Plans计 划 的 结 构DESIGN INPUT设 计 输 入 Input Checklists输 入 检 查 表DESIGN REVIEW设 计 评 审 Combination Devices载 药 器
2、 械 Preparation For Reviews评 审 准 备 Why Design Reviews设 计 评 审 的 原 因 Types Of Design Review Meetings设 计 审 核 会 议 的 类 型 Design Review Requirements设 计 评 审 要 求 End Of Initial Design初 步 设 计 的 结 束DESIGN OUTPUT设 计 输出 Documenting Design Output设 计 输 出 的 记 录 成 文 Acceptance Criteria确 认 条 件 Design Output Approval设
3、 计 输 出 审 批DESIGN VERIFICATION AND VALIDATION设 计 确 认 和 验 证 Design Evaluation versus Specifications根 据 规 格 进 行 设 计 评 估 Software Validation软件 验 证 Labeling Verification标 识 确 认DESIGN TRANSFER设 计 转 移DESIGN CHANGES设 计 变 更DESIGN HISTORY FILE设 计 历 史 文 件EXHIBITS示 例 Design Input Requirements Procedure设 计 输 入 规
4、 定 程 序 INTRODUCTION引 言The Safe Medical Devices Act of 1990 added design validation requirements to the GMP requirements in section 520(f) of The Act. Section 820.30 of the Quality System (QS) regulation lists the design control requirements that manufacturers should satisfy to be in compliance. This
5、 chapter describes design controls and provides guidance to assist manufacturers in complying with design control requirements.Design Control Guidance for Medical Device Manufacturers is another document that may assist manufacturers in understanding the intent of the design control requirements. Th
6、is manual interprets the language of the QS regulation and explains the underlying concepts in practical terms. Do It By Design: An Introduction to Human Factors in Medical Devices is a document that contains background information about human factors as a discipline, describes and illustrates devic
7、e problems and discusses human factors principles and methods as a part of the design control system. Both of these manuals are possible resources for manufacturers who are either developing or improving their design control system. These manuals are also available through DSMA. 一九九零年的安全医疗器械法案在法案的 5
8、20(f)部分的 GMP 规定中加入了设计验 证规定。质量体系规章的 820.30 部分列举了生产商为合规须遵守的设计控制规定。本章阐 述设计控制,并且为协助生产商遵守设计控制要求提供向导。 “医疗器械生产商设计控制指南”是另外一份帮助生产商了解设计控制要求主旨的文件。这本手册用通俗的语言表达质量体系规章的内容并解释内涵概念。“通过设计完成任务:医疗器械中的人为因素介绍”是一个包含了把人为因素作为学科的背景信息的文件,该文件对器械问题进行描述并解释并探讨作为设计控制系统一部分的人为因素的原理和方法。对正在编制或改善设计控制系统的生产商来说,两本手册都是可能的资源。这些手册还可以从 DSMA 处
9、获得。 Coverage覆 盖 范 围The design controls section 820.30 of the QS regulation applies to the design of products, and processes and changes to existing designs and processes. Changes to existing designs should be made in accordance with design control requirement even if the original design was not subj
10、ect to these requirements. Design controls are not retroactive to completed portions of ongoing design programs.Each manufacturer of any class III or class II device, and class I devices automated with computer software and those listed below shall establish and maintain procedures to control the de
11、sign of the device in order to make certain that specified design requirements are met. Manufacturers of other Class I devices should develop and document their devices under their own design control system because the documentation is needed to help meet the device master record requirements in 820
12、.181 and marketing submission requirements. Thus, manufacturers of exempt Class I devices are encouraged to use 820.30, Design Controls, as guidance.QS 规章 820.30 部分设计控制适用于产品设计以及对现有设计和工艺进行的加工和改变。即使原有设计不需遵守设计控制要求,对这些设计做出的更改仍需遵守设计控制要求规定。设计控制对持续性的设计程序中已经完成的部分不具备追溯效力.任何二类、三类器械的生产商、计算机软件控制的自动化一类器械厂商以及以下列出
13、的一类器械的生产商必须建立并保持一套控制器械设计的程序以确保规定的设计要求得到满足。其他一类器械的生产商应该根据他们自身的设计控制系统开发器械并做记录,因为企业需要这些文件帮助他们遵守 820.181 器械主记录要求以及市场申报规定。因此,鼓励豁免的一类 器械生产商把820.30, 设计控制作为指南使用。 Classification Section Class I Devices Subject to Design Controls Listed in Paragraph 820.30(a)(2) 868.6810 Catheter, Tracheobronchial Suction 878
14、.4460 Glove, Surgeons 880.6760 Restraint, Protective 892.5650 System, Applicator, Radionuclide, Manual 892.5740 Source, Radionuclide Teletherapy All Sect. Devices automated with computer software 分类章节 868.6810 878.4460 880.6760 892.5650 892.5740 所有章节 须遵守列在第 820.30(a)(2) 段中设计控制的一类器械导管,气管支气管抽吸器外科手术手套约
15、束、防护系统、高频电极(applicator),放射性核素、手动远程治疗放射性核素源计算机软件控制的自动化器械 The design requirements for the device are primarily specified by the manufacturer; however, FDA has a few design requirements in the 21 CFR Part 801 labeling regulations and in Parts 1000-1050 which cover radiological and electronic products.
16、A few of the FDA design requirements are in standards. For example, some parameters for medical gloves are in standards by the American Society for Testing and Materials (ASTM). (That is, medical gloves are required to meet these standards in order to be substantially equivalent to gloves already in
17、 commercial distribution.)设计规定主要由生产者自己制定,但是 FDA 在联邦规章典籍 21 CFR 801 部分 标识 规则 以及 1000-1050 部分中有一些设计规定,主要针对影像学和电子产品。FDA 所要求的规格有一些是英制单位。例如,美国材料试验协会(ASTM)制定的医用手套的一些参数是英制的。(也就是说,医用手套必须符合这些标准以便最大限度地符合已经进入商业销售的手套标准) QUALITY SYSTEM 质 量 体 系Each manufacturer is required to establish and maintain a quality syst
18、em that is appropriate for the specific medical device(s) designed or manufactured 820.5 and 820.1(a)(3), and that meets the requirements of Part 820. Therefore, the details of design control systems will vary depending on the complexity of the product or process being designed. However, all non-exe
19、mpt manufacturers including very small manufacturers and manufacturers that design less complex devices or processes are expected to define, document and implement design control procedures and other quality system procedures as called for in the regulation. One of these, a sample design input proce
20、dure, is exhibited at the end of this chapter.每个生产商都必须建立并维护一套适用于其设计或制造的特定的医疗器械的质量体系 820.5 个 820.1(a)(3),该质量体系需遵守 820 部分的要求。因此,设计控制系统的具体内容会根据正在设计的产品或工艺的复杂程度而有所不同。但是,所有未得到豁免的器械生产商,包括非常小的生产商和设计相对简单的器械或工艺的生产商都需要明确,记录成文并执行设计控制程序以及其他的规章需求的质量体系程序。本章结尾例举了其中之一,即设计输入程序样本。 Manufacturers may establish one desig
21、n control procedure to cover the various design control sections in 820.30; or, they may use one or more procedures for each topic. Multiple procedures may be easier to develop, update and implement. Medium to large manufacturers may have several additional procedures to support their main design co
22、ntrol procedures. Design control procedures may be part of the quality system records (QSR) noted in section 820.186.生产商可以制定一套设计控制程序来包括 820.30 部分中的不同的设计控制,或者可以为每个主题使用一个或多个程序。多重程序可能更容易编制、更新和执行。中大型生产商可能有好几个附加程序来支持主设计控制程序。设计控制程序可以作为 820.186 部分所注明的质 量体系记录(QSR)的一部分。Personnel Training 员工培训Personnel traini
23、ng in 820.25 is one of the quality system requirements, which applies to employees that perform any activity covered by the QS regulation including all design activities.Manufacturers are required to establish procedures for identifying training needs and making certain that all personnel are traine
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