21 CFR § 820
Quality System Regulation
质量体系手册
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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Subpart A—General Provisions A部分-—总则 820。1 Scope。 820。1范围 820。3 Definitions。 定义
820。5 Quality system. 质量体系
Subpart B—Quality System Requirements B部分——质量体系要求
820.20 Management responsibility。 管理者职责 820。22 Quality audit. 质量审核 820。25 Personnel。 职员
Subpart C—Design Controls C部分—-设计控制 820.30 Design controls。 设计控制
Subpart D—Document Controls D部分-—文件控制 820.40 Document controls. 文件控制
Subpart E—Purchasing Controls E部分——采购控制
820.50 Purchasing controls。 采购控制
Subpart F—Identification and Traceability F部分——标识和可追溯性 820.60 Identification. 标识
820。65 Traceability。 可追溯性
Subpart G—Production and Process Controls G部分—-生产和过程控制
820.70 Production and process controls. 产品和过程控制
820.72Inspection，measuring， and test equipment.
检查、测量，测试仪器 820。75 Process validation。 过程确认
Subpart H—Acceptance Activities H部分—接收活动
820.80 Receiving, in—process, finished device acceptance。
and
接收设备准则,过程设备准则，最终设备准则 820.86 Acceptance status。 接收状态
Subpart I—Nonconforming Product I部分-—不合格产品
820。90 Nonconforming product。 不合格产品
Subpart J—Corrective and Preventive Action J部分—-纠正预防措施
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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820。100 Corrective and preventive action。
纠正预防措施
Subpart K-Labeling and Packaging Control K部分——标签与包装控制 820.120 Device labeling. 产品标识
820.130 Device packaging. 产品包装
Subpart L—Handling, Distribution, and Installation Storage, M部分——记录
820。180 General requirements。 总要求
820.181 Device master record。 产品控制记录 820.184 Device history record. 产品历史记录 820.186 Quality system record. 质量体系记录 820.198 Complaint files. 客户抱怨文件 Subpart N—Servicing 820.200 Servicing。
Subpart O—Statistical Techniques 820.250 Statistical techniques。
Authority: Secs. 501， 502， 510， 513， 514， 515， 518， 519， 520, 522, 701， 704， 801， 803 of the Federal Food， Drug， and Cosmetic Act （21 U。S.C. 351， 352， 360， 360c， 360d， 360e， 360h， 360i, 360j， 360l, 371, 374, 381, 383）。
L部分-—操作、存储、分配以及安装 820。140 Handling。 操作 820.150 Storage. 存储
820。160 Distribution. 分配 820.170 Installation. 安装
Subpart M—Records
Subpart A-General Provisions .............................................................................................. 4 § 820。1 Scope。 ................................................................................................................ 4
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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Subpart A—General Provisions § 820.1 Scope。
820.1范围 （a) Applicability.
适用性
（1)
Current good manufacturing practice (CGMP） requirements are set forth in
this quality system regulation。 The requirements in this part govern the methods used in， and the facilities and controls used for, the design， manufacture, packaging， labeling， storage, installation， and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food， Drug, and Cosmetic Act （the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part， and not in others， that manufacturer need only comply with those requirements applicable to the operations in which it is engaged。 With respect to class I devices， design controls apply only to those devices listed in § 820。30（a) (2）。 This regulation does not apply to manufacturers of components or parts of finished devices， but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance。 Manufacturers of human blood and blood components are not subject to this part， but are subject to part 606 of this chapter.
在本质量体系法规（QSR)中阐述了CGMP的要求。本部分中的要求规定了在下列情况下使用的方法：所有的预期用于人类的最终器械产品的设计、制造、包装、标记、储存、安装和服务中使用的方法。本部分的要求可确保最终器械的安全有效，并符合联邦食品、药品和化妆品法案。本部分内容确定了适用于最终器械的制造商的基本要求。如果制造商从事的一些操作符合本部分的要求，而不是其他部分的要求，则该制造商只需符合那些用于这些操作上的要求。对于I类医疗器械，设计控制仅适用于820.3（a）（2）部分列出的那些器械。本法规不适用于最终器械的组件和部件的制造商，但鼓励这样的制造商使用本法规中的适宜条款做指南.生产人体血液和血液组件的制造商可不遵守本部分的要求，但要遵守本章606的要求。
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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（2） The provisions of this part shall be applicable to any finished device as defined in
this part, intended for human use， that is manufactured, imported， or offered for import in any State or Territory of the United States， the District of Columbia, or the Commonwealth of Puerto Rico。 本部分条款可适用于任何本部分规定的、预期用于人类的最终器械，这样的器械可在美国、哥伦比亚地区和波多黎各共和国生产或进口到这些国家。
(3） In this regulation the term ‘‘where appropriate’' is used several times。 When a
requirement is qualified by ‘‘where appropriate,’’ it is deemed to be ‘‘appropriate’’ unless the manufacturer can document justification otherwise。 A requirement is ‘‘appropriate'’ if nonimplementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.
本法规中使用几次词语“适当处”。当一个要求被“适当处”修饰时，这一要求就被认为是“适当的”,除非制造商能以文件的形式提出其它的正当理由。如果不实施某个要求就会导致产品不满足其规定的要求或制造商不能开展必要的纠正措施，则可认为这一要求是“适当的”。
（b） Limitations。 The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event that it is impossible to comply with all applicable regulations, both in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.
局限性。除非明确声明有其他情况,否则本部分中质量体系法规是对本章其他部分的法规的补充.如果遵守所有适用法规（包括本部分的法规和本章其他部分的法规)是不可能的,则指定应用于讨论中器械的法规应代替其他通用的要求。
(c) Authority. Part 820 is established and issued under authority of sections 501, 502, 510， 513, 514， 515, 518， 519, 520, 522， 701， 704， 801， 803 of the act (21 U.S.C. 351， 352, 360， 360c， 360d， 360e, 360h, 360i, 360j, 360l， 371， 374, 381, 383）. The failure to comply with any applicable provision in this part renders a device adulterated under section 501（h） of the act. Such a device, as well as any person responsible for the failure to comply， is subject to regulatory action.
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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权威性.820部分内容的是参照权威法案501，502，510,513，514，515，518,519,520，522，701,704，801，803（21U.S.C.351，352，360，360c，360d,360e，360h,360i，360j，360l,371，374，381，383 ）而制定和发布的。如果器械没有符合本部分的任何适用条款会,按照501法案，可认为该种器械为伪劣产品,造成器械不符合性的人员都要负一定责任。
（d） Foreign manufacturers. If a manufacturer who offers devices for import into the United States refuses to permit or allow the completion of a Food and Drug Administration (FDA） inspection of the foreign facility for the purpose of determining compliance with this part, it shall appear for purposes of section 801(a） of the act, that the methods used in， and the facilities and controls used for， the design， manufacture， packaging， labeling, storage， installation， or servicing of any devices produced at such facility that are offered for import into the United States do not conform to the requirements of section 520(f） of the act and this part and that the devices manufactured at that facility are adulterated under section 501（h） of the act。
国外制造商：如果将器械进口到美国的制造商拒绝接受FDA对其国外设施的检查，以确定是否符合本部分801法案的内容，则可认为生产该器械所使用的方法，设施、设备以及在该场地下生产的、将要进口到美国的器械的设计、生产、包装、标记、贮存、安装或服务不符合520（f)法案和本部分内容的要求，并且按照501（h)法案的规定，该场地下生产的器械为伪劣产品.
(e) Exemptions or variances. 豁免或特殊许可: (1）
Any person who wishes to petition for an exemption or variance from any
device quality system requirement is subject to the requirements of section 520（f）（2） of the act。 Petitions for an exemption or variance shall be submitted according to the procedures set forth in § 10。30 of this chapter, the FDA’s administrative procedures。 Guidance is available from the Center for Devices and Radiological Health, Division of Small Manufacturers Assistance， （HFZ–220）, 1350 Piccard Dr., Rockville， MD 20850, U。S.A。， telephone 1–800–638–2041 or 1–301– 443–6597， FAX 301–443–8818. (1)任何申请对器械质量体系要求豁免或特殊许可的人员都要遵守法案520(f)（2）的要求。按照本章10。30中阐述的程序要求(FDA的管理程序），将豁免或特殊许可的申请提交给FDA. 可从器械与辐射健康中心,小型制造商服务部（HFZ—220)获得指南.
(2) FDA may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best interest of the public health.
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.
当代理商确定这样的特殊许可是为了公众健康的利益,FDA可鼓励并允许器械的质量体系要求有一些特殊许可.而且这样的许可只有在保持器械一直有利于公众的健康时才能保持其有效性,在没有特殊许可的情况下不能大量的制造器械. 1. § 820。3 Definitions. 定义
（a） Act means the Federal Food， Drug, and Cosmetic Act, as amended （secs. 201–903, 52 Stat。 1040 et seq., as amended （21 U。S。C. 321–394)）。 All definitions in section 201 of the act shall apply to the regulations in this part。
法案是指联邦食品、药品和化装品法案。法案中201部分中规定的所有定义都适用于本部分的法规。
(b） Complaint means any written, electronic， or oral communication that alleges deficiencies related to the identity， quality， durability, reliability, safety， effectiveness, or performance of a device after it is released for distribution.
抱怨：抱怨是指任何以书面、口头、电讯的形式宣称,已放行销售的医疗器械在其特性、质量、耐用性、可靠性、安全性、有效性及性能等方面存在不足的行为.
（c) Component means any raw material， substance, piece， part, software， firmware, labeling, or assembly which is intended to be included as part of the finished， packaged， and labeled device.
组件:组件是指任何原材料、物质、零件、部件、软件、固件(软件硬件相结合）、标记或装配件，可作为最终器械、包装器械和标记器械的一部分。
(d) Control number means any distinctive symbols， such as a distinctive combination of letters or numbers， or both， from which the history of the manufacturing， packaging， labeling， and distribution of a unit, lot, or batch of finished devices can be determined. 控制号码是指任何有特色的符号，如：字母或数字的有特色的组合，或者两者的结合，从中可以确定最终产品批或单元的生产、包装、标记和销售的历史。
(e) Design history file （DHF） means a compilation of records which describes the design history of a finished device.
设计历史文件（DHF）是指记录的汇编,描述了一个最终器械的设计历史。
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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（f） Design input means the physical and performance requirements of a device that are used as a basis for device design。
设计输入是指器械的物理要求和性能要求，其可作为器械的设计基础.
(g) Design output means the results of a design effort at each design phase and at the end of the total design effort。 The finished design output is the basis for the device master record。 The total finished design output consists of the device， its packaging and labeling, and the device master record.
设计输出是指每一设计阶段和总体设计的设计努力的结果。最终器械的设计输出是由器械、器械的包装、标签和器械主记录构成。
（h) Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements， and to identify problems.
设计评审是指对设计的形成文件的、全面的、系统的检查以便评价设计要求的充分性，设计满足要求的能力以及识别问题。
(i） Device history record (DHR） means a compilation of records containing the production history of a finished device.
设备历史记录（DHR）是指包含最终器械生产历史的记录汇编
(j） Device master record (DMR） means a compilation of records containing the procedures and specifications for a finished device。
器械主记录（DMR)是指包含最终器械的程序和规范的记录汇编。
(k） Establish means define， document (in writing or electronically), and implement。 建立是指规定、形成文件(手写的、电子的）和实施。
（l） Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized。
最终器械是指任何适于使用或能够运行的器械或器械的附件，无论其是否经包装、标记或灭菌.
（m） Lot or batch means one or more components or finished devices that consist of a single type, model， class， size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits。
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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批是指最终器械、一个或多个组件，其可由唯一的型号、规格、类型、尺寸、结构或软件版本构成,这些器械和组件是在相同的条件下生产的,在规定的范围内有相同的特性和质量. (n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer’s quality policy and quality system。
有行政职责的管理者是指有权确定质量方针和质量体系或对质量方针和质量体系作出更改的制造商的高级雇员。
(o） Manufacturer means any person who designs, manufactures, fabricates， assembles， or processes a finished device。 Manufacturer includes but is not limited to those who perform the functions of contract sterilization， installation, relabeling， remanufacturing， repacking, or specification development， and initial distributors of foreign entities performing these functions.
制造商是指任何对最终器械进行设计、生产、制作、组装或加工的人.制造商包括但并不仅仅只限于是那些完成灭菌、安装、重新标记、重新制造、重新包装、制定规范的人，或者完成上述操作的境外初始销售商
(p） Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent， or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer。
制造材料是指任何使用的材料或物质，这些材料的使用可便于生产加工，或在生产过程中产生的伴随物或副产物,这些物质的是作为残留物或杂质存在于最终器械上，它的产生不是设计出来的，也不是制造商想要的。
（q） Nonconformity means the nonfulfillment of a specified requirement。 不合格是指不满足规定要求
(r) Product means components， manufacturing materials, in— process devices, finished devices, and returned devices。
产品是指组件、制造材料、过程中的器械、最终器械和返回器械。
（s) Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness—for- use， including safety and performance. 质量是指器械满足良好使用性能的总体的特性和性能，包括安全和性能.
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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（t) Quality audit means a systematic, independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively， and that these procedures are suitable to achieve quality system objectives. 质量审核是指按照规定的时间间隔对制造商的质量体系进行的系统的、独立的检查，以确定质量体系活动和活动的结果符合质量体系程序，并确保质量体系程序得到有效的实施并适合于实现质量体系的目标.
(u) Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.
质量方针是指与组织质量有关的总的意图和方向，质量方针是由最高管理层制定的。 (v) Quality system means the organizational structure， responsibilities, procedures, processes， and resources for implementing quality management。
质量体系是指完成组织的质量管理所需的组织结构、职责、程序、过程和资源.
(w) Remanufacturer means any person who processes, conditions, renovates, repackages， restores， or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. 二手制造商是指加工、改造、翻修、再次包装、修复或对最终器械采取其他措施来对器械的性能或安全规范或预期用途做重要更改的人。
(x） Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.
返工是指对不合格产品采取的措施以便使其在放行和销售前满足规定的器械主记录的要求。 （y） Specification means any requirement with which a product， process, service， or other activity must conform。
规范是指产品、过程、服务或其他活动必须满足的任何要求.
(z) Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled。 确认是指通过检查和提供客观证据确认能够持续的满足指定用途的特殊要求。
（1） Process validation means establishing by objective evidence that a process
consistently produces a result or product meeting its predetermined specifications. 过程确认是指通过客观证据确定过程能持续生产出满足其预先确定的规范要求。
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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(2) Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).
设计确认是指通过客观证据来确定器械规范符合用户需求和预期使用用途.
(aa） Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled。
验证是指通过检查和提供客观证据以确认规定的要求是否得到满足.
1. § 820。5 Quality systems 质量体系
Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device（s) designed or manufactured， and that meets the requirements of this part.
每一个制造商应建立和保持一个适用于指定医疗器械设计和生产的质量体系并满足本部分的要求.
Subpart B—Quality System Requirements B部分：质量体系要求
§ 820。20 Management responsibility 管理职责
(a） Quality policy： Management with executive responsibility shall establish its policy
and objectives for, and commitment to， quality。 Management with executive
responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.
质量方针:最高管理者应制定企业的质量方针和目标和对质量的承诺。最高管理者应确保质量方针在组织内各层次得到理解、实施和保持。
（b） Organization： Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.
组织：每一个制造商应建立和保持适宜的组织结构以确保器械的设计和生产按照本部分的要求进行。
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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（1） Responsibility and authority： Each manufacturer shall establish the appropriate
responsibility, authority， and interrelation of all personnel who manage， perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks。
职责和权限：每一个制造商应确定人员的职责、权限和相互关系，这些人员负责管理、执行和评价对质量有影响的工作。
(2) Resources： Each manufacturer shall provide adequate resources， including the
assignment of trained personnel， for management, performance of work, and assessment activities， including internal quality audits， to meet the requirements of
this part.
资源：每一个制造商应提供充足的资源以满足本部分的要求，包括指定培训管理人员，操作人员 的人员，以及评价活动（包括内部审核）。
（3) Management representative： Management with executive responsibility shall
appoint， and document such appointment of, a member of management who,
irrespective of other responsibilities, shall have established authority over and responsibility for:
管理者代表：最高管理者应任命一名管理者并记录这样的任命,不管在其他方面的职责如何，他应该具有以下方面的职责和权限：
（i） Ensuring that quality system requirements are effectively established and
effectively maintained in accordance with this part; and 确保质量管理体系要求能按照本部分的要求得到有效的建立和保持。 （ii） Reporting on the performance of the quality system to management with executive responsibility for review. 向最高管理者汇报质量体系的业绩。 （c) Management review: Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient
frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The results of quality system reviews shall be documented。
管理评审：最高管理者按照规定的时间间隔和按照规定程序所确立的有效频率评价质量
管理体系的适宜性和有效性,以确保质量体系满足本部分的要求和制造商的质量方针和目标.质量体系评审的日期和结果应形成文件。
（d） Quality planning： Each manufacturer shall establish a quality plan which defines
the quality practices, resources and activities relevant to devices that are designed and
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manufactured。 The manufacturer shall establish how the requirements for quality will be met.
质量策划:每一个制造商应建立一个质量计划以规定与所设计和生产的器械有关的质量规
范，资源和活动.制造商应确定质量要求是如何得到满足的. (e) Quality system procedures: Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.
质量体系程序：每一个制造商应建立质量体系程序和说明。适当时，应确定质量体系中所使用的文件的结构.
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1. § 820。22 Quality audit 质量审核
Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited。 Corrective action（s）, including a reaudit of deficient matters, shall be taken where necessary。 A report of the results of each quality audit, and reaudit（s） where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters being audited. The dates and results of quality audits and reaudits shall be documented. 每一个制造商应建立质量审核的程序并完成这样的审核以确保质量体系符合经确定的质量体系要求并保持其有效性。进行质量审核的人员应不能直接负责受审核的事项。必要时要采取纠正措施包括对不合格的再次审核.应报告每次质量审核的结果，这样的结果应由负责受审核方的负责人进行评审。质量审核和再次审核的结果和日期应形成文件。
2. § 820.25 Personnel
人员
(a） General: Each manufacturer shall have sufficient personnel with the necessary education， background， training, and experience to assure that all activities required by this part are correctly performed。
总则:每一个制造商应具有充足的人力资源，这些人员应具备必要的教育、培训和经验以确保正确的完成本部分所要求的活动。
（b) Training： Each manufacturer shall establish procedures for identifying training
needs and ensure that all personnel are trained to adequately perform their assigned responsibilities。 Training shall be documented。
培训:每一个制造商应建立一个识别培训需求的程序以确保所有的人员能够接受适宜的培训以完成本职工作。培训应形成文件。
(1） As part of their training， personnel shall be made aware of device defects which
may occur from the improper performance of their specific jobs。
作为培训的一部分，工作人员应了解由于其不恰当的操作而造成的器械缺陷。
(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.
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进行验证和确认活动的人员应了解可能遇到的器械缺陷和故障。
3. Subpart C—Design Controls C部分:设计控制
4. § 820.30 Design controls 设计控制 (a) General
总则 (1）
Each manufacturer of any class III or class II device， and the class I devices
listed in paragraph （a)(2） of this section， shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met。
每一个II类和III类器械的制造商和本部分列出的I类器械的制造商应建立和保持程序以控制器械的设计，确保规定的设计要求得到满足.
(2) The following class I devices are subject to design controls： 下列器械应进行设计控制：
(i） Devices automated with computer software； and 由计算机软件进行驱动的器械
（ii) The devices listed in the chart below. （Note： I excluded the chart， it does not apply to CTI.)
下表列出的器械
（b） Design and development planning: Each manufacturer shall establish and maintain
plans that describe or reference the design and development activities and define responsibility for the implementation。 The plans shall identify and describe the interfaces with different groups or activities that provide， or result in， input to the design and development process. The plans shall be reviewed, updated and approved as design and development evolves.
设计和开发的策划:每一个制造商应建立和保持设计和开发活动的计划并规定实施职责。计划应识别和描述各不同部门或活动的接口，这些部门或活动提供或产生设计和开发过程的输入。随设计和开发的进展，计划应得到评审、更新和批准。
（c) Design input： Each manufacturer shall establish and maintain procedures to
ensure that the design requirements relating to a device are appropriate and address the intended use of the device， including the needs of the user and patient。 The procedures shall include a mechanism for addressing incomplete, ambiguous or
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conflicting requirements。 The design input requirements shall be documented and shall be reviewed and approved by designated individual（s)。 The approval, including the date and signature of the individual(s） approving the requirements， shall be documented. 设计输入：每一个制造商应建立和保持程序以确保与器械相关的要求是适宜的并阐述用户和
患者的要求。设计输入的要求应形成文件并由指定的人员评审和批准。应记录批准日期和批准人的签名。
（d） Design output: Each manufacturer shall establish and maintain procedures for
defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified。 Design output shall be documented, reviewed， and approved before release. The approval， including the date and signature of the individual（s) approving the output， shall be documented.
设计输出：每一个制造商应建立和保持程序以规定和记录设计输出，以便对设计输入要求的符合性进行充分的评价.设计输出程序应包含或引用接收准则，确保识别出那些对器械的正常运作十分必要的设计输出结果。设计输出在发布前应形成文件并得到评审和批准。应记录批准日期和批准人的签名
（e） Design review: Each manufacturer shall establish and maintain procedures to
ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development。 The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s） who does not have direct responsibility for the design stage being reviewed， as well as any specialists needed. The results of a design review， including identification of the design， the date and the individual(s） performing the review， shall be documented in the design history file (the DHF)。
设计评审：每一个制造商应建立和保持设计评审程序,以确保对设计结果的正式评审在设计开发的适宜阶段得到策划和实施.评审的参加者包括与所评审的设计和开发阶段有关的职能的代表，不直接负责所评审的设计和开发阶段的人员和所需的专家。在设备历史记录（DHR)中记录设计评审的识别、日期和完成评审的人员。
（f) Design verification: Each manufacturer shall establish and maintain procedures for
verifying the device design。 Design verification shall confirm that the design output
meets the design input requirements。 The results of the design verification, including
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identification of the design， method(s）， the date and the individual(s） performing the verification, shall be documented in the design history file. 设计验证:每一个制造商应建立和保持设计验证程序。设计验证应确保设计输出满足设计输入要求。在设备历史记录(DHR)中记录设计验证的识别、验证的方法、日期和验证的人员。
(g) Design validation: Each manufacturer shall establish and maintain procedures for
validating the device design。 Design validation shall be performed under defined operating conditions on initial production units， lots or batches， or their equivalents。 Design validation shall ensure that the devices conform to defined user
needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis， where appropriate. The results of the design validation， including identification of the design, method(s), the date and the individual(s) performing the validation, shall be documented in the design history file。
设计确认：每一个制造商应建立和保持设计确认程序.设计确认活动应在规定的操作条
件下完成。设计确认应确保器械符合规定的用户需求和预期的使用用途，应包括在真实或模拟使用条件下对产品单元的测试。适当时,设计确认应包括软件的确认和风险分析.在设计历史记录（DHF)中记录设计确认的识别、方法、日期和完成确认的人员。
(h） Design transfer： Each manufacturer shall establish and maintain procedures to
ensure that the device design is correctly translated into production specifications。 设计转换：每一个制造商应建立和保持程序以确保器械的设计能够正确的转化成生产规范.
（i） Design changes: Each manufacturer shall establish and maintain procedures for the identification, documentation, validation， or where appropriate verification， review, and approval of design changes before their implementation。
设计更改：每一个制造商应建立和保持设计更改的程序，程序应包括设计更改的识别、
记录、确认，适当时更改实施前的验证、评审和批准。
(j) Design history file： Each manufacturer shall establish and maintain a design history file for each type of device. The design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
设备历史记录（DHF）：每一个制造商应建立和保持每一类型器械的设备历史记录。DHF应包括必要的记录，这些记录应能证明器械的设计是按照符合已批准的设计计划和本部分的要求来完成的.
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1. Subpart D—Document Controls D部分 文件控制
2. § 820。40 Document controls 820。40 文件控制
Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following： 制造商应建立和保持程序以控制所有本部分要求的文件。程序应规定以下内容：
(a) Document approval and distribution: Each manufacturer shall designate an
individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document， shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use。
文件的批准和发布：每一个制造商应指定一名人员在文件发布前，评审文件的适宜性和批准文件，以确定满足本部分的要求。文件的批准，包括批准的日期和批准人的签名,应形成文件.满足本部分要求的文件应在使用现场方便获得，或必要时获得.应迅速从使用现场清除所有的作废文件，以防止非预期的使用。
(b) Document changes： Changes to documents shall be reviewed and approved by an
individual（s） in the same functions or organization that performed the original review and approval, unless specifically designated otherwise。 Approved changes shall be communicated to the appropriate personnel in a timely manner。 Each manufacturer shall maintain records of changes to documents。 Change records shall include a
description of the change, identification of the affected documents, the signature of the approving individual(s）， the approval date， and when the change becomes effective.
文件更改：除非有其他的特别指定,否则，对文件的更改应得到原审批部门或组织的评审和批准.应采用适当的方式将文件的更改通知有关人员。每一个制造商应保持文件的更改记录。更改记录应包括对更改的描述，受更改影响的文件的识别，批准人的签字，批准日期和更改生效的时间。
1. Subpart E—Purchasing Controls E部分 采购控制
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2. § 820。50 Purchasing controls 820.50采购控制
Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
每一个制造商应建立和保持程序以确保所有采购的或以其它形式接收到的产品和服务满足规定的要求.
（a) Evaluation of suppliers, contractors, and consultants: Each manufacturer shall
establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors and consultants. Each manufacturer shall：
供方、分承包方和顾问的评价。每一个制造商应建立和保持要求，包括质量要求，供方、分承包方和顾问应满足这些要求。每一个制造商应：
（1) Evaluate and select potential suppliers, contractors， and consultants on the basis
of their ability to meet specified requirements， including quality requirements。 The evaluation shall be documented。
以满足规定的要求包括质量要求的能力为基础,评价和选择潜在的供方、分承包方和顾问。评价应形成文件
(2） Define the type and extent of control to be exercised over the product， services,
suppliers, contractors， and consultants based on the evaluation results.
以评价的结果为基础，确定对产品、服务、供方、分承包方和顾问的控制的类型和程度。
(3） Establish and maintain records of acceptable suppliers, contractors, and
consultants。
建立和保持可接受的供方、分承包方和顾问的记录。
(c) Purchasing data： Each manufacturer shall establish and maintain data that clearly
describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services。 Purchasing documents shall include, where possible, an agreement that the suppliers， contractors and consultants, agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the change may affect the quality of a finished device. Purchasing data shall be approved in accordance with § 820.40.
采购数据:每一个制造商应建立和保持所采购的或以其它形式接收的产品和服务的数据，该数据能清楚的描述规定的要求包括质量体系要求.如果可能，采购文件应包括这样的协议，即供方、分承包方和顾问同意将有关产品或服务的更改通知给制造商，以便使制造商判断更改是否对最终器械的产品质量有影响。应按照820.40要求批准采购数据.
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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1. Subpart F—Identification and Traceability F部分 标识与可追溯性
2. § 820.60 Identification 820。60标识
Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt， production, distribution, and installation to prevent mixups。 在产品的接收、生产、销售和安装过程中，每一个制造商应建立和保持标识产品的程序,以防止混用。
3. § 820.65 Traceability 820。65 可追溯性
Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit， lot or batch of finished devices and where appropriate components。 The procedures shall facilitate corrective action。 Such identification shall be documented in the device history record. 每一个生产下列器械的制造商，应利用对最终器械和适当的组件的单元、生产批标识控制号码来建立和保持识别产品的程序：外科植入器械、支持或维持生命的器械、或按照标记上提供的使用说明进行合理使用时产生的操作故障会对使用者产生重大伤害。程序应便于纠正措施的实施.这样的标识应记录在设备历史记录中。
4. Subpart G—Production and Process Controls G部分 生产和过程控制
5. § 820.70 Production and process controls
生产和过程控制
（a） General： Each manufacturer shall develop， conduct, control， and monitor
production processes to ensure that a device conforms to its specifications。 Where
deviations from device specifications could occur as a result of the manufacturing process， the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include：
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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总则:每一个制造商应建立、实施、控制和监视生产过程以确保器械符合其规范.在生产过程中会导致生产的器械与器械规范有偏差,制造商应建立和保持描述过程控制必要性的过程控制程序，以确保符合规范要求。过程控制应包括：
（1) Documented instructions, standard operating procedures （SOPs）， and methods that define and control the manner of production;
形成文件的指导书，标准的操作程序(SOP，S)，规定和控制生产方式的方法；
(2) Monitoring and control of process parameters and component and device
characteristics during production;
生产过程中，过程参数、组件和器械特性的监视和测量； （3） Compliance with specified reference standards or codes；
对规定的参考标准或代码的符合性;
（4） The approval of processes and process equipment； and， 过程和过程设备的批准；和
（5） Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.
操作工的操作准则应以形成文件的标准或经确定和批准的代表性的样本来表示
（b） Production and process changes: Each manufacturer shall establish and maintain
procedures for changes to a specification, method， process, or procedure。 Such
changes shall be verified or where appropriate validated according to § 820.75， before implementation and these activities shall be documented. Changes shall be approved in accordance with § 820.40.
生产和过程的更改：每一个制造商应建立和保持对规范、方法、过程或程序的更改.这样的更改应在实施之前得到验证或适当时按照820。75要求进行确认.应将这些活动形成文件。更改应按照820.40的规定得到批准。
(c）Environmental control： Where environmental conditions could reasonably be expected to have an adverse effect on product quality， the manufacturer shall establish and maintain procedures to adequately control these environmental conditions. Environmental control system（s） shall be periodically inspected to verify that the system， including necessary equipment, is adequate and functioning properly。 These activities shall be documented and reviewed. 环境控制:环境条件对产品质量有影响，制造商应建立和保持程序以充分的控制这些环境条件。应对环境控制体系进行周期的检查，以验证该体系,包括必要的设备充分适宜并运行良好.
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这些活动应形成文件并得到评审。
(d） Personnel: Each manufacturer shall establish and maintain requirements for
health， cleanliness， personal practices, and clothing of personnel if contact between
such personnel and product or environment could reasonably be expected to have an adverse effect on product quality. The manufacturer shall ensure that maintenance and other personnel who are required to work temporarily under special environmental conditions are appropriately trained or supervised by a trained individual.
人员：如果人员和产品或人员和环境的接触能够对产品质量产生不良影响，每一个制造商应建立和保持对健康、清洁、人员规范和人员服装的要求.组织应确保所有在特殊环境条件下临时工作的人员接受适当的培训或在训练有素的人员监督下工作。
(e) Contamination control： Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adversely effect on product quality.
污染控制：每一个制造商应建立和保持程序，以防止对产品质量有不良影响的设备或产品的污染.
(f） Buildings: Buildings shall be of suitable design and contain sufficient space to perform
necessary operations， prevent mixups, and assure orderly handling。 建筑物:建筑物的设计应适宜，要有足够的空间来完成必要的操作。
(g) Equipment: Each manufacturer shall ensure that all equipment used in the
manufacturing process meets specified requirements and is appropriately designed， constructed, placed, and installed to facilitate maintenance， adjustment， cleaning, and use。
设备:每一个制造商应确保在生产过程中使用的所有设备满足规定的要求，并对其进行适宜的设计、构造、放置和安装以便于维护、调整、清洁和使用.
(1) Maintenance schedule： Each manufacturer shall establish and maintain schedules
for the adjustment， cleaning and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities， including the date and
individual(s) performing the maintenance activities, shall be documented. 维护计划:每一个制造商应建立和保持对设备的调整、清洁和维护计划，以确保满足生产规范。维护活动包括维护活动的日期和人员都应形成文件。
（2） Inspection： Each manufacturer shall conduct periodic inspections in accordance
with established procedures to ensure adherence to applicable equipment
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maintenance schedules。 The inspections， including the date and individual conducting the inspections, shall be documented. 检查:每一个制造商应按照已建立的程序完成周期的检查以确保符合适用的设备维修计划。检查包括检查的日期和人员应形成文件.
(3） Adjustment： Each manufacturer shall ensure that any inherent limitations or
allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments。 调整:每一个制造商应确保要求周期调整的设备的固有局限性和容许的公差都贴在设备上或跟随设备附近,或完成这些调整的人员能够方便获得。
(h） Manufacturing material: Where a manufacturing material could reasonably be
expected to have an adverse effect on product quality， the manufacturer shall establish and maintain procedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device’s quality。 The removal or reduction of such manufacturing material shall be documented。
制造材料:当制造材料将会对产品质量有不良影响，制造商应建立和保持对这类材料的去
除和使用程序以确保对其去除和限制数量 (i） Automated processes： When computers or automated data processing systems are
used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol。 All software changes shall be validated before approval and issuance. These validation activities and results shall be documented. 自动化过程：如果在生产或质量体系中使用计算机或自动化的数据处理系统时,制造商应按照已制定的方案，对软件的预期用途进行确认。在软件更改的批准和发布前应对更改进行确认。这些确认活动和结果应形成文件。
6. § 820。72 Inspection, measuring， and test equipment 检验、测量和试验设备
（a) Control of inspection, measuring and test equipment： Each manufacturer shall
ensure that all inspection， measuring, and test equipment, including mechanical， automated， or electronic inspection and test equipment, is suitable for its intended
purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated，
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inspected， checked， and maintained. The procedures shall include provisions for handling， preservation, and storage of equipment， so that its accuracy and fitness for use are maintained. These activities shall be documented。
检验、测量和试验设备的控制.每一个制造商应确保所有的检验、测量和试验设备能适于其预期的目的并能产生有效的结果。这些设备包括机械设备、软件驱动设备、电子检验和试验设备。每一个制造商应建立和保持程序以确保设备能够定期的校准、检定、检查和保持.程序还应包括设备的搬运、防护和贮存的规定，以便使其精确性和使用的适宜性得到保持。这些活动应形成文件。
(b） Calibration： Calibration procedures shall include specific directions and limits for
accuracy and precision. When accuracy and precision limits are not met， there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. These activities shall be documented. 校准:校准程序应包括特定的目的和准确度和精确度的极限。当未满足准确度和精确度的极限时,应提供修补措施以再次确定极限并评价是否对器械质量有任何不良影响。这些活动应形成文件。
(1) Calibration standards： Calibration standards used for inspection， measuring， and
test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in—house standard。
校准标准:检验、测量和试验设备所使用的校准标准应可溯源到国家或国际标准。如果没有国家或国际标准或国家或国际标准不适用时，制造商应使用独立的、可复验性的标准。如果没有适用的标准，制造商应建立和保持自己内部的标准。
(2) Calibration records： The equipment identification, calibration dates， the individual performing each calibration and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and the individuals responsible for calibrating the equipment.
校准记录：设备的标识、校准日期、校准人员和下次校准日期应形成文件。这些记录在设备的零件上或跟随设备附近或使用设备的人员或负责校准设备的人员能方便获得。 1. § 820。75 Process validation 过程确认
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(a) Where the results of a process cannot be fully verified by subsequent inspection and
test， the process shall be validated with a high degree of assurance and approved according to established procedures。 The validation activities and results， including the date and signature of the individual（s) approving the validation and where appropriate the major equipment validated, shall be documented。
如果过程结果不能被后续的检验和试验过程得以充分的验证，则应按照规定的程序对该过程进行充分的确认。确认活动和结果、包括日期和完成确认活动人员的签名,适用时主要的确认设备应形成文件。
(b） Each manufacturer shall establish and maintain procedures for monitoring and
control of process parameters for validated processes to ensure that the specified requirements continue to be met。
每一个制造商应建立和保持监视程序并控制确认过程的过程参数以确保规定的要求继续得到满足.
(1) Each manufacturer shall ensure that validated processes are performed by qualified
individual(s）.
每一个制造商应确保过程确认由有资格的人员来完成。
（2) For validated processes, the monitoring and control methods and data, the date
performed, and， where appropriate, the individual（s） performing the process or the major equipment used shall be documented. 对于确认的过程，确认方法的控制和监视，确认资料和完成确认的日期，适当时完成确
认的人员和使用的主要设备应形成文件。
(d) When changes or process deviations occur， the manufacturer shall review and
evaluate the process and perform revalidation where appropriate。 These activities shall be documented. 确认有更改或出现偏差时，制造商应评审和评价过程，适当时，进行再确认。这些活动应形成文件.
2. Subpart H—Acceptance Activities
接受活动
3. § 820。80 Receiving， in-process, and finished device acceptance 820。80 进货产品(receiving device）、过程产品和最终产品的接收
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（a) General: Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections， tests， and other verification activities。
总则：每一个制造商应建立保持接收活动的程序。接收活动应包括检验、试验或其他验证活动.
(b） Receiving acceptance activities： Each manufacturer shall establish and maintain procedures for acceptance of incoming product。 Incoming product shall be inspected, tested， or otherwise verified as conforming to specified requirements。 Acceptance or rejection shall be documented。
进货产品的接收活动：每一个制造商应建立和保持进货产品的接收程序.应对进货产品进行检验、试验和验证以确保符合规定的要求。对进货产品的接收或拒绝应形成文件.
（c） In-process acceptance activities： Each manufacturer shall establish and maintain
acceptance procedures, where appropriate， to ensure that specified requirements for in—process product are met。 Such procedures shall ensure that in-process product
is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received， and are documented。 过程产品的接收活动:每一个制造商应建立和保持过程产品的接收程序以确保满足规定的过程产品要求.这样的程序应确保过程产品处于受控的状态,直到所要求的检验、试验或其他验证活动得以完成,必要时得到批准.
（d） Final acceptance activities: Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria。 Finished devices shall be held in quarantine or otherwise adequately controlled until released。 Finished devices shall not be released for distribution until:
最终产品的接受活动。 每一个制造商应为最终产品的接收建立和保持程序以确保每一个产品批的产品满足接收准则。最终器械在放行前应接受严格的检查或得到充分的控制。对最终器械放行发布前应完成下列活动：
（1） the activities required in the DMR are completed；
完成器械的主记录中要求的活动；
（2） the associated data and documentation is reviewed；
相关的资料和文件要得到评审；
(3） the release is authorized by the signature of a designated individual（s); and 有指定的人员的授权才能放行产品 （4） the authorization is dated。
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批准的日期
(e) Acceptance records： Each manufacturer shall document acceptance activities
required by this part. These records shall include：
接收记录：每一个制造商应记录本部分所要求的接收活动，记录应包括： （1) the acceptance activities performed； 所完成的接收活动
(2) the dates acceptance activities are performed；
完成接收活动的日期 （3) the results； 结果
（4） the signature of the individual（s） conducting the acceptance activities; and
执行接收活动人员的签名
(5) where appropriate， equipment used。 These records shall be part of the device history record.
适当时，所使用的设备。这些记录应作为设备历史记录的一部分。
4. § 820。86 Acceptance status 820。86接收状态
Each manufacturer shall identify by suitable means the acceptance status of product， to indicate the conformance or nonconformance of these items with acceptance criteria. The identification of acceptance status shall be maintained throughout, manufacturing, packaging， labeling， installation, and servicing of the product to ensure that only products which have passed the required acceptance activities are distributed， used, or installed.
每一个制造商应采用适宜的方法识别产品的接收状态，以表明产品对接收准则的符合性或不符合性。在整个产品的制造、包装、标记、安装和服务的过程中应保持产品接收状态的标识，以确保产品只有在满足所要求的接收活动后才能得到销售、使用或安装.
Subpart I-Nonconforming Product I 不合格产品
5. § 820。90 Nonconforming product 820。90 不合格产品
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(a) Control of nonconforming product。 Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation， evaluation， segregation， and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented. 不合格产品的控制：每一个制造商都应建立和保持程序以控制不符合规定要求的产品。这些程序应规定对不合格产品的标识、文件、评价、隔离和处置。对不合格产品的评价应包括确定是否有必要进行调查或告知负责不合格产品的组织或人员。应将评价和所做的任何调查形成文件.
(b） Nonconformity review and disposition。
不合格品的评审和处置
（1） Each manufacturer shall establish and maintain procedures that define the
responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process。 Disposition of nonconforming product shall be documented。 Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use.
每一个制造商应建立和保持程序以规定对不合格产品的评审的职责和处置的权限。这些程序中应阐明评审和处置的过程.对不合格产品的处置应形成文件。文件应包括对使用不合格产品的合理解释以及授权使用不合格产品的人员的签字。
(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework， to ensure that it meets its current approved, specifications。 Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product， shall be documented in the device history record。 每一个制造商应建立和保持返工的程序，包括返工后对不合格产品的重新测试和重新评价，以确保重新评价活动包括确定返工对产品产生的不良影响应记录在器械的历史记录中. 1. Subpart J—Corrective and Preventive Action J 部分 纠正和预防措施
§ 820。100 Corrective and preventive action
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820。100 纠正预防措施
（a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for: 每一个制造商应建立和保持实施纠正预防措施的程序。程序应包括下列要求：
（1) Analyzing processes， work operations， concessions， quality audit reports，
quality records, service records， complaints， returned product， and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems。 Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems；
分析过程、操作、让步、质量审核记录、质量记录、服务记录、抱怨、退回的产品和其
他有关质量资料的信息来源以识别现存的或潜在的不合格产品的原因，或其他质量问题.必要时，使用其他统计技术方法来识别反复发生的质量问题；
（2) Investigating the cause of nonconformities relating to product， processes， and
the quality system；
调查与产品、过程和质量体系有关的不合格的原因；
(3） Identifying the action(s) needed to correct and prevent recurrence of nonconforming
product and other quality problems；
识别需要采取纠正的措施以防止不合格产品的再次发生或其他质量问题；
（4) Verifying or validating the corrective and preventive action to ensure that such action
is effective and does not adversely affect the finished device;
验证或确认纠正和预防措施以确保这样的措施是有效的并不会对最终器械产生不良影响. （5） Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems；
实施和记录所需的方法和程序的更改以纠正和防止识别、出的问题。
(6) Ensuring that information related to quality problems or nonconforming product is
disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems； and
确保与质量问题或不合格产品有关的信息能直接发给那些直接负责产品质量保证或防止问题发生的这样的人员。 (7)
Submitting relevant information on identified quality problems， as well as corrective and preventive actions, for management review。
针对识别出的质量问题提交相关信息以及纠正和预防措施用来进行管理评审。
(b) All activities required under this section, and their results, shall be documented。
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本部分所要求的所有活动和活动的结果应形成文件。
2. Subpart K—Labeling and Packaging Control K 标记和包装控制
3. § 820.120 Device labeling
标记和包装控制
Each manufacturer shall establish and maintain procedures to control labeling activities。 每一个制造商应建立和保持程序以控制器械的标记活动。
(a) Label integrity。 Labels shall be printed and applied so as to remain legible and affixed
during the customary conditions of processing， storage， handling， distribution, and where appropriate， use。
标签的完整性。在顾客的加工、存贮、搬运、销售，适用时包括使用在内的过程中，应保持标签的清晰和完整。
（b） Labeling inspection。 Labeling shall not be released for storage or use until a
designated individual(s） has examined the labeling for accuracy including， where applicable， the correct expiration date, control number， storage instructions，
handling instructions and any additional processing instructions. The release, including the date and signature of the individual(s） performing the examination, shall be documented in the device history record. 标记的检查：经指定人员的对标记的准确性进行检查后才能存贮和使用标记。适用时标
记应包括正确的有效期，控制码、存贮指导说明、搬运指导说明和任何附加的操作指导说明。放行的日期和执行检验的人员的签名应记录在器械的历史记录中。 (c） Labeling storage. Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent mixups.
标记的存贮。每一个制造商标签的存贮应能提供恰当的标识防止标签的混用。
（d) Labeling operations. Each manufacturer shall control labeling and packaging
operations to prevent labeling mixups。 The label and labeling used for each production unit， lot， or batch shall be documented in the device history record. 标记的操作。每一个制造商应控制标签和包装操作以防止标签的混用。每一批产品标签和标记的使用都应记录在器械的历史记录中
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(e) Control number。 Where a control number is required by § 820。65， that control number shall be on or shall accompany the device through distribution。
控制码。按照820。65的要求要有控制码，在整个器械的销售过程中，控制码应始终在器械上或伴随器械附近。
4. § 820.130 Device packaging 820。130器械包装
Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage， handling, and distribution.
每一个制造商应确保器械的包装和货运集装箱的设计和构造都能防止器械在顾客的处理、存贮、搬运和销售时发生变更和损害.
5. Subpart L—Handling, Storage, Distribution, and Installation L 搬运、存贮、销售和安装
6. § 820.140 Handling 820。140 搬运
Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling。
每一个制造商应建立和保持程序以防止在搬运的过程中发生器械的混淆、损害、破坏、污染或其他对产品有不良影响的事情发生.
7. § 820.150 Storage 820.150 存贮
（a） (a）
Each manufacturer shall establish and maintain procedures for the
control of storage areas and stock rooms for product to prevent mixups, damage， deterioration, contamination, or other adverse effects pending use or distribution to ensure that no obsolete， rejected， or deteriorated product is
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used or distributed。 When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate.
每一个制造商应建立和保持程序以控制产品的存贮区域和房间以防止器械的混淆、损害、破坏、污染或其他对产品使用和销售有不良影响的事情发生，并防止使用或销售过期的、作废的或受损的产品。如果随着存贮时间的推移，产品质量逐渐恶化，应考虑产品存货周期是否恰当，适当时还要评价产品存贮条件。
(b) Each manufacturer shall establish and maintain procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms。 每一个制造商应建立和保持程序以描述接收产品的方法和把产品发送到存贮区域和房间的方法
8. § 820.160 Distribution 820。160 销售
（a） Each manufacturer shall establish and maintain procedures for control and
distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution。 Where a device's fitness—for—use or quality deteriorates over time， the procedures shall ensure that expired devices or devices deteriorated beyond acceptable fitness for use are not distributed
每一个制造商应为控制和销售最终器械建立和保持程序以确保只有经批准的器械才能销售。应对定单进行评审以确保在销售前解决一些模糊问题或错误.当器械的使用性能或质量随着时间的推移发生恶化，这些程序应确保过期的器械或恶化程度不可接受的器械不被销售出去.
(b） Each manufacturer shall maintain distribution records which include or refer to the
location of：
每一个制造商应保持销售记录，销售记录应包括下列内容或指出出处： (1) The name and address of the initial consignee;
初始代销人的的名称和地址
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(2) The identification and quantity of devices shipped, 所运载的器械的数量和标识 （3）The date shipped； and 运载日期
（4) Any control number(s） used. 所使用的任何控制码
9. § 820。170 Installation 820。170 安装
（a)Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions， and where appropriate test procedures。 Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation。 The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person（s） installing the device
每一个需要有安装的器械的制造商应建立和保持充分与适宜的安装和检查指导说明,适用时包括测试程序。指导书和程序应包括确保恰当安装和说明指导以便使器械在安装后能安预期的期望运行。制造商销售器械时，应附带指导书和程序.或让安装人员获得指导书和程序.
(b)
The person installing the device shall ensure that the installation， inspection,
and any required testing are performed in accordance with the manufacturer’s instructions and procedures and shall document the inspection and any test results to demonstrate proper installation. 安装人员应确保对器械的安装、检查、和所要求的试验应按照制造商的指导说明和程序进行并应记录检验和试验结果以证实安装的正确性。
10. Subpart M—Records M 记录
11. § 820.180 General requirements 820。180 总要求
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All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of the FDA designated to perform inspections。 Such records， including those not stored at the inspected establishment， shall be made readily available for review and copying by FDA employee（s）。 Such records shall be legible and shall be stored to minimize deterioration and to prevent loss。 Those records stored in automated data processing systems shall be backed up。
本部分所要求的所有记录应保持在生产场地或制造商的其他能获得记录的负责部门或者FDA执行检验的人员。这些记录包括不在检验现场出现的记录都应便于FDA人员的评审和复印。这些记录应清晰、易于识别，保存时应防止破损和丢失。用自动存贮系统保存的记录应该有备份。
（a) Confidentiality： Records deemed confidential by the manufacturer may be marked to aid the FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter.
机密性。制造商认为应保密的记录要作记号以帮助FDA确定那些信息是可以透露的。
（b） Record retention period： All records required by this part shall be retained for a
period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
记录的保持期限。本部分所要求的所有记录都应有一定的保持期限，该保存期限应至少相当于所规定的医疗器械的寿命期,但从制造商放行产品进行销售的日期起不少于2年.
(c) Exceptions： This section does not apply to the reports required by § 820.20(c） Management review, § 820.22 Quality audits， and supplier audit reports used to meet the requirements of § 820.50（a） Evaluation of suppliers, contractors, and consultants， but does apply to procedures established under these subsections. Upon request of a designated employee of the FDA， an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part， and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken。
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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例外.本部分的记录要求不适用于管理评审（820。20c）报告、质量审核820.22)的报告和对供方所使用的是否满足820。50（a)供方、分承包商和咨询机构评价要求的审核报告，但适用于这些规定中所要求的程序.按照FDA的要求,管理层的人员应能以书面形式证明管理评审、本部分所要求的质量审核和供方的审核（适用时）已经完成并形成文件、并记录完成的日期和采取的纠正措施。820。181器械的主记录
12. § 820.181 Device master record 器械主记录
Each manufacturer shall maintain device master records （DMRs)。 Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 820。40. The DMR for each type of device shall include， or refer to the location of， the following information:
每一个制造商应保持器械的主记录（DMR，s）。每一个制造商应确保每一个器械的主记录的准备和批准都应符合820。40的要求。每一型号的器械的主记录应包括下列信息或指出出处. (a) Device specifications including appropriate drawings, composition, formulation,
component specifications， and software specifications；
器械规范其中包括适当的图纸、成份、配方设计、组件规范和软件规范；
（b) Production
process
specifications
including
the
appropriate
equipment
specifications， production methods, production procedures, and production environment specifications；
生产过程规范包括适当的设备规范、生产方法、生产程序和生产环境规范；
（c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment used;
质量保证程序和规范包括接收准则和使用的质量保证设备；
(d) Packaging and labeling specifications， including methods and processes used； and 包装和标签规范包括所使用的方法和过程；
(f) Installation， maintenance， and servicing procedures and methods。 安装、维护和服务程序和方法
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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13. § 820。184 Device history record
8203184 器械历史记录
Each manufacturer shall maintain device history records (DHRs）。 Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part。 The DHR shall include， or refer to the location of， the following information：
每一个制造商应保持器械的历史记录（DHR,s）。每一个制造商应建立和保持程序以确保保持每一批产品的历史记录并能证明器械的生产是符合DMR和本部分要求。器械的历史记录应包括下列信息或指出出处。
（a） The dates of manufacture； 生产日期;
(b) The quantity manufactured； 生产数量； (c） The quantity released for distribution； 放行销售的数量
(d) The acceptance records which demonstrate the device is manufactured in accordance
with the DMR;
能证明器械是符合DMR要求的接收记录
(e） The primary identification label and labeling used for each production unit; and 每一个生产批所使用的主要的识别标签和标记；
(g) Any device identification(s) and control number（s） used. 任何器械的识别和控制码
14. § 820。186 Quality system records 820.186 质量体系记录
Each manufacturer shall maintain a quality system record （QSR）。 The QSR shall include, or refer to the location of， procedures and the documentation of activities required by this part that are not specific to a particular type of device（s)， including but not limited to the records required by § 820。20。 Each manufacturer shall ensure that the QSR is prepared and approved in accordance with § 820。40.
每一个制造商应保持一个质量体系记录（QSR)。QSR应包括（指出出处）本部分所要求的活动的程序和文件，这些活动不是针对特殊类型的器械,包括但不局限于820。20所要求的记录.每一个制造商应确保QSR的制定和批准符合820.40的要求.
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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15. § 820。198 Complaint files 820。198 抱怨文档
（a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that：
每一个制造商应保持抱怨文档。每一个制造商应建立和保持程序以确保由指定的部门负责接收、评审和评价抱怨。这样的程序应确保:
（1） All complaints are processed in a uniform and timely manner； 适当地和及时地处理所有的抱怨；
（2） Oral complaints are documented upon receipt; and 收到口头抱怨时要及时记录
（3） Complaints are evaluated to determine whether the complaint represents an event
which is required to be reported to the FDA under part 803 or 804 of this chapter， Medical Device Reporting。 要对抱怨进行评价以确定所抱怨的事件是否需要按照本章803和804的要求报告给FDA的医疗器械的报告部门。
(b） Each manufacturer shall review and evaluate all complaints to determine whether an
investigation is necessary。 When no investigation is made， the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate。
要评审和评价所有的抱怨以确定是否有必要进行调查。当没有进行调查时,制造商应保持记录其中包括记录没进行调查的原因以及决定不进行调查的负责人的名字。
（c） Any complaint involving the possible failure of a device， labeling， or packaging to
meet any of its specifications shall be reviewed， evaluated, and investigated, unless
such investigation has already been performed for a similar complaint and another investigation is not necessary。
除非已经调查过类似的抱怨,否则对任何有关器械故障、标签和包装对其规范的满足性的抱怨都应进行评审、评价和调查。
(d） Any complaint that represents an event which must be reported to FDA under part
803 or 804 of this chapter shall be promptly reviewed, evaluated and investigated by a designated individual（s） and shall be maintained in a separate portion of the complaint files or clearly identified。 In addition to the information required by §
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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820.198, records of investigations under this paragraph shall include a determination of：
如果按照本章803和804的要求，要由指定的人员对必须报告给FDA的抱怨事件进行快速的评审、评价和调查，并将该抱怨的文档单独保存或做明显标识。除了820。198（e）所要求的信息,调查记录应确定以下问题:
(1） Whether the device failed to meet specifications;
器械是否没有满足规范 （2) Whether the device was being used for treatment or diagnosis； and
器械是否用来诊断或治疗用
(3） The relationship, if any， of the device to the reported incident or adverse event。 器械与所报告的不良事件有何关系
(e) When an investigation is made under this section, a written record of each
investigation shall be maintained by the formally designated unit identified in paragraph (a） of this section. The record of investigation shall include: 当进行调查时，应由指定的部门保持调查记录，调查记录应包括： (1） The name of the device； 器械的名称；
（2) The date the complaint was received； 收到抱怨的日期；
(3） Any device identification（s) and control number（s) used； 所使用的器械的标识和控制码；
(4） The name, address, and phone number of the complainant; 抱怨人的联系电话、地址和姓名;
（5) The nature and details of the complaint; 抱怨的性质和细节。
(6) The dates and results of the investigation; 调查的日期和结果
（7） Any corrective action taken； and 所采取的纠正措施；
(8） Any reply to the complainant。 对抱怨的回复。
(f) When the manufacturer’s formally designated complaint unit is located at a site
separate from the actual manufacturing establishment， the investigated complaint(s) and the record（s) of investigation shall be reasonably accessible to the manufacturing
establishment.
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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如果制造商指定的负责处理抱怨的部门不在生产场地，则对抱怨的调查和调查的记录应使生产场地易于获得.
(g） If a manufacturer's formally designated complaint unit is located outside of the
United States, records required under this section shall be accessible in the United States at either:
如果制造商指定的负责处理抱怨的部门不在美国,则本部分所要求的记录也应能在美国获
得：
（1) A location in the United States where the manufacturer's records are regularly
kept； or
在美国定期保持制造商记录的机构位置 （2） The location of the initial distributor。
初始销售商的位置
16. Subpart N—Servicing N部分 服务
17. § 820.200 Servicing 820.200 服务
(a） Where servicing is a specified requirement， each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements。
当规定有服务要求时,每一个制造商应建立和保持执行和验证服务满足规定要求的指导书和程序。
(b） Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 or 804 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of § 820.198.
每一个制造商应按照820.100的要求，采用适宜的统计方法分析服务报告 (c） Service reports shall be documented and shall include：
如果按照本部分803和804的要求,接收的服务报告阐述的事件是必须报告给FDA的，则制造商应自动认为该报告为顾客抱怨，并按照820.198的要求进行处理。
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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(1) The name of the device serviced； 所服务的器械的名称；
(2） Any identification(s） and control number（s) used; 所使用的器械的标识和控制码 (3） The date of the service； 服务日期；
(4) The individual(s) servicing the device； 服务人员；
（5） The service performed； and 所执行的服务；
(6) The test and inspection data. 检验和实验数据
Subpart O-Statistical Techniques O部分——统计技术
18. § 820.250 Statistical techniques 820。250 统计技术
(a） Where appropriate， each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling， and verifying the acceptability of process capability and product characteristics。
适当时，每一个制造商应建立和保持识别有效统计技术的程序，这些统计技术可用于建立、控制和验证过程能力和产品特性的可接受性.
（b) Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed。 These activities shall be documented。 当使用抽样方法时,应记录抽样计划并且抽样计划要以有效的统计理论分析为基础。每一个制造商应建立和保持程序以确保抽样方法对预期用途的充分适宜性，当抽样计划发生变更时，可确保得到评审。应记录这些活动。
Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations 联邦注册局出版，法规与准则，61册，第195号，，1996年10月7日
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