FDA 21 CFR QSR820 中英文对照版本

21 CFR § 820

Quality System Regulation

质量体系手册

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, and finished device acceptance.

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

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, Storage, Distribution, and Installation

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 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).

Subpart A—General Provisions (4)

§ 820.1 Scope. (4)

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

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。

(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 us ed 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.

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.

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。

(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.

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。

(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。

(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。

(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

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 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。

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 documente d.

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.

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 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

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 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。

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

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。

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 procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include:

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：

win7各版本中英文对比

Win7各版本中英文对比 windows7版本分32位和64为，基本都有：Windows 7Starter(简易版)，Windows 7HomeBasic(家庭普通版)，Windows 7HomePremium(家庭高级版)，Windows 7Professional(专业版)，Windows 7Enterprise(企业版)，Windows 7Ultimate(旗舰版)，请看他们的区别： Windows 7Starter(简易版) 缺少的功能：航空特效功能；同时运行三个以上同步程序；家庭组（HomeGroup）创建；完整的移动功能。 可用范围：仅在新兴市场投放，仅安装在原始设备制造商的特定机器上，并限于某些特殊类型的硬件。 忽略后台应用，比如文件备份实用程序，但是一旦打开该备份程序，后台应用就会被自动触发。 Windows 7HomeBasic(家庭普通版) 缺少的功能：航空特效功能；实时缩略图预览、Internet连接共享。 可用范围：仅在新兴市场投放（不包括美国、西欧、____和其它发达国家）。 Windows 7HomePremium(家庭高级版) 包含功能：航空特效功能；多触控功能；多媒体功能（播放电影和刻录DVD）；组建家庭网络组。 可用范围：全球。 Windows 7Professional(专业版) 包含功能：加强网络的功能，比如域加入；高级备份功能；位置感知打印；脱机文件夹；移动中心（MobilityCenter）；演示模式（PresentationMode）。 可用范围：全球。 Windows 7Enterprise(企业版) 包含功能：Branch缓存；DirectAccess；BitLocker；AppLocker；VirtualizationEnhancements （增强虚拟化）；Management（管理）；CompatibilityandDeployment（兼容性和部署）；VHD 引导支持。 可用范围：仅批量许可。 Windows 7Ultimate(旗舰版) 包含功能：所有功能。 可用范围：有限。 另外Windows 7专业版拥有很多高级功能，包括Location aware printing、Domain&Group policy controls、远程桌面控制、高级备份和系统文件加密。Windows 7企业版和旗舰版相比专业版新增了BitLocker驱动器加密、AppLocker、直接访问、BranchCache和MUI语言包。

UCP600中英文对照版

《跟单信用证统一惯例》（UCP600）中英文对照版 Article 1 Application of UCP 第一条统一惯例的适用范围 The Uniform Customs and Practice for Documentary Credits, 2007 Revis ion, ICC Publication no. 600 (“UCP”) are rules that apply to any do cumentary credit (“credit”) (including, to the extent to which they may be applicable, any standby letter of credit) when the text of t he credit expressly indicates that it is subject to these rules. The y are binding on all parties thereto unless expressly modified or ex cluded by the credit. 跟单信用证统一惯例，2007年修订本，国际商会第600号出版物，适用于所有在正文中标明按本惯例办理的跟单信用证（包括本惯例适用范围内的备用信用证）。除非信用证中另有规定，本惯例对一切有关当事人均具有约束力。 Article 2 Definitions 第二条定义 For the purpose of these rules: 就本惯例而言： Advising bank means the bank that advises the credit at the request of the issuing bank. 通知行意指应开证行要求通知信用证的银行。 Applicant means the party on whose request the credit is issued. 申请人意指发出开立信用证申请的一方。

《跟单信用证统一惯例UCP600》中英对照共75页word资料

《跟单信用证统一惯例（UCP600）》(中英对照版) 作者：国际商会易水寒译阅读2912次更新时间：2007-3-29 《跟单信用证统一惯例（UCP600）》 Article 1 Application of UCP 第一条统一惯例的适用范围 The Uniform Customs and Practice for Documentary Credits, 2007 Revision, ICC Publication no. 600 (“UCP”) are rules that apply to any documentary credit (“credit”) (including, to the extent to which they may be applicable, any standby letter of credit) when the text of the credit expressly indicates that it is subject to these rules. They are binding on all parties thereto unless expressly modified or excluded by the credit. 跟单信用证统一惯例，2007年修订本，国际商会第600号出版物，适用于所有在正文中标明按本惯例办理的跟单信用证（包括本惯例适用范围内的备用信用证）。除非信用证中另有规定，本惯例对一切有关当事人均具有约束力。 Article 2 Definitions 第二条定义 For the purpose of these rules: 就本惯例而言： Advising bank means the bank that advises the credit at the request of the issuing bank.

WIN7各版本区别详解

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Win7旗舰版与专业版以及其他版本区别在哪

Win7旗舰版与专业版以及其他版本区别在哪 大家都知道Win7系统有许多版本，例如旗舰版、专业版、企业版等等。但是很多小伙伴不知道这些版本之间有 什么区别，下面就给大家仔细来说说这几个版本各自的特点，方便各位小伙伴们更加清楚的了解它们之间的区别。 Windows7各版本介绍： 家庭普及版介绍： 家庭版普及版特色：无限应用程序，实时缩略图预览，增强视觉体验（仍无Aero），高级网络支持（ad-hoc无线 网络和互联网连接支持ICS），移动中心（Mobility Center）等功能。 家庭高级版介绍： 相对家庭普及版增加了，航空特效功能，多触控功能，多媒体功能，播放电影和刻录DVD，组建家庭网络组。

Windows7家庭版是针对一些家庭用户，相对专业版和 旗舰版功能要少出很多，针对家庭实用功能进一步的加强，保留了日常应用的所有功能，但是不具备专业版和旗舰版 中的特殊功能，如：Aero效果。如果对操作系统要求不高 只是为了玩游戏，上网，听歌，炒股的用户选用家庭版已 经足够使用。 Windows7企业版介绍： 企业版特色：提供一系列企业级增强功能： BitLocker，内置和外置驱动器数据保护，AppLocker，锁 定非授权软件运行，DirectAccess，无缝连接基于Windows Server 2008 R2的企业网络，BranchCache，Windows Server 2008 R2网络缓存，等等。 包含功能： Branch缓存，DirectAccess，BitLocker，AppLocker，Virtualization Enhancements（增强虚拟化），Management（管理），Compatibility and Deployment（兼容性和部署），VHD引导支持。 Windows7企业版针对企业用户得到了多方面的加强， 如果企业相关用户选择操作系统用Windows7企业版操作系 统绝对是明智的选择，企业版操作系统和，家庭版可以说 是两个概念。

(完整版)信用证样本中英文对照1

跟单信用证：目前采用SWIFT格式，依据《UCP600》规定，例样如下： FROM：CITIBANK INTERNATIONAL，LOS ANGELES, U.S.A. 开证行：花旗银行美国洛杉矶 TO：BANK OF CHINA QINGDAO BRANCH，QINGDAO，CHINA 通知行：中国银行青岛分行中国青岛 :27: SEQUENCE OF TOTAL 1/1 :27: 电文序列、报文页次1/1 :40A: FORM OF DOCUMENTARY CREDIT IRREVOCABLE :40A: 跟单信用证格式不可撤销 :20: DOCUMENTARY CREDIT NUMBER CRED1523349 :20: 跟单信用证号CRED1523349 :3lC: DATE OF ISSUE 070906 :31C: 开证日期070906 :40E：APPLICABLE RULES UCP LATEST VERSION :40E: 适用规则《UCP》最新版本 :31D: DATE AND PLACE OF EXPIRY 071102 U.S.A. :31D: 有效期和有效地点071102 美国 :50: APPLICANT UNITED OVERSEAS TEXTILE CORP. 220E 8TH STREET A682 LOS ANGELES U.S.A. :50: 开证申请人美国大华纺织公司 220栋，8号街，682室 洛杉矶 美国 :59: BENEFICIARY QINGDAO QINGHAI CO.,LTD.

186 CHONGQIN ROAD QINGDAO 266002 CHINA :59: 受益人青岛青海有限公司 重庆路186号 中国青岛266002（邮编） :32B: CURRENCY CODE, AMOUNT: USD58575，00 :32B: 货币代码和金额58575.00美元 :39A：PRECENTAGE CREDIT AMOUNT TOLERANCE 10/10 :39A: 信用证金额上下浮动百分比10/10（10%） :41A: A V AILABLE WITH.. BY.. CITIUS33LAX BY DEFERRED PAYMENT :41A: 兑付方式花旗银行洛杉矶分行以延期付款方式兑付 :42P: DEFERRED PAYMENT DETAILS AT 90 DAYS AFTER B/L DATE :42P: 延期付款细节提单签发日后90天 :43P: PARTIAL SHIPMENTS NOT ALLOWED :43P: 分批装运不允许 :43T: TRANSSHIPMENT NOT ALLOWED :43T: 转运不允许 :44E: PORT OF LOADING/AIRPORT OF DEPARTURE QINGDAO PORT，CHINA :44E: 装运港/始发航空站中国青岛港 :44F: PORT OF DISCHARGE/AIRPORT OF DESTINATION LOS ANGELES PORT，U.S.A. :44F: 卸货港/目的航空站美国洛杉矶港 :44C: LATEST DATE OF SHIPMENT 071017 :44C: 最晚装运期071017 :45A: DESCRIPTION OF GOODS AND/OR SERVICES +TRADE TERMS: CIF LOS ANGELES PORT，U.S.A. ORIGIN:CHINA + 71000M OF 100% POLYESTER WOVEN DYED FABRIC

跟单信用证统一惯例UCP600

跟单信用证统一惯例 （ICC UCP600中英文对照版） 第一条UCP的适用范围 第二条定义 第三条解释 第四条信用证与合同 第五条单据与货物、服务或履约行为 第六条兑用方式、截止日和交单地点 第七条开证行责任 第八条保兑行责任 第九条信用证及其修改的通知 第十条修改 第十一条电讯传输的和预先通知的信用证和修改 第十二条指定 第十三条银行之间的偿付安排 第十四条单据审核标准 第十五条相符交单 第十六条不符单据、放弃及通知 第十七条正本单据及副本 第十八条商业发票 第十九条涵盖至少两种不同运输方式的运输单据 第二十条提单 第二十一条不可转让的海运单 第二十二条租船合同提单 第二十三条空运单据 第二十四条公路、铁路或内陆水运单据 第二十五条快递收据、邮政收据或投邮证明 第二十六条“货装舱面”、“托运人装载和计数”、“内容据托运人报称”及运费之外的费用 第二十七条清洁运输单据 第二十八条保险单据及保险范围 第二十九条截止日或最迟交单日的顺延 第三十条信用证金额、数量与单价的伸缩度 第三十一条部分支款或部分发运 第三十二条分期支款或分期发运 第三十三条交单时间 第三十四条关于单据有效性的免责 第三十五条关于信息传递和翻译的免责 第三十六条不可抗力 第三十七条关于被指示方行为的免责 第三十八条可转让信用证 第三十九条款项让渡 Article 1 Application of UCP 第一条统一惯例的适用范围 The Uniform Customs and Practice for Documentary Credits, 2007 Revision, ICC Publication no. 600 (“UCP”) are rules that apply to any documentary credit (“credit”) (including, to the extent to which they may be applicable, any standby letter of c redit)