美国FDA 医疗器械体系法规QSR820中英文对照(四)

SubpartC--Design Controls设计控制Sec. 820.30Design controls.设计控制(a)General. 总则(1)Each manufacturer of any class II

SubpartC--Design Controls设计控制

Sec. 820.30Design controls.设计控制

(a)General. 总则

(1)Each manufacturer of any class III or class II device, and the class I deviceslisted in paragraph (a)(2) of this section, shall establish and maintainprocedures to control the design of the device in order to ensure thatspecified design requirements are met.

(2)The following class I devices are subject to design controls:

(i)Devices automated with computer software; and

(ii)The devices listed in the following chart.

(1)II类和III类器械,以及在本章节(a)(2)清单下的I类器械制造商应当建立和维护一个控制器械设计的规程,从而保证特定的设计需求得以实现。

2)以下的I类器械应当进行设控制:

(i)由计算机软件自动操作的器械;并且

(ii)以及以下表格所列的器械。

Section

章节

Device

器械

868.6810

Catheter, Tracheobronchial Suction.

气管插管

878.4460

Glove, Surgeon's.

外科手套

880.6760

Restraint, Protective.

保护性约束器械

892.5650

System, Applicator, Radionuclide, Manual.

放射性药物人工给药系统

892.5740

Source, Radionuclide Teletherapy.

放疗用放射源

(b) Design and development planning.设计和开发计划(策划)

Each manufacturer shallestablish and maintain plans that describe or reference the design anddevelopment activities and define responsibility for implementation. The plansshall identify and describe the interfaces with different groups or activitiesthat provide, or result in, input to the design and development process. Theplans shall be reviewed, updated, and approved as design and developmentevolves.

每个制造商应当建立和维护一个描述或包括设计和开发活动以及定期实施职责的策划书。策划书应当界定和描述内部为设计开发所设定的不同组别或活动之间的联系,这些活动包括输入、产生结果等。该策划随着设计和开发的推进进行审核、更新,并经批准。

(c) Design input.设计输入

Each manufacturer shallestablish and maintain procedures to ensure that the design requirementsrelating to a device are appropriate and address the intended use of thedevice, including the needs of the user and patient. The procedures shallinclude a mechanism for addressing incomplete, ambiguous, or conflictingrequirements. The design input requirements shall be documented and shall bereviewed and approved by a designated individual(s). The approval, includingthe date and signature of the individual(s) approving the requirements, shallbe documented.

每个制造商应当建立和维护一个程序来保证与设备相关的设计要求符合设备预期使用,包括病人和使用者的需求。该规程应当包括一个能够处理不完整、不明确、矛盾需求的途径。设计输入的需求应当指定人员进行记录,并审核和批准。该批准(其中包括批准需求的人员的签字和日期)应当予以记录。

(d) Design output. 设计输出

Each manufacturer shall establish and maintain procedures fordefining and documenting design output in terms that allow an adequateevaluation of conformance to design input requirements. Design outputprocedures shall contain or make reference to acceptance criteria and shallensure that those design outputs that are essential for the proper functioningof the device are identified. Design output shall be documented, reviewed, andapproved before release. The approval, including the date and signature of theindividual(s) approving the output, shall be documented.

每个制造商应当确定和维护一个程序,用于界定和记录设计输出,从而给予一个符合设计输入要求的充分评估。设计输出规程应当包含或考虑可接受标准并且应保证这些设计输出得以确定。因为这些输出对设备正常运作来说非常重要。设计输出应当文件化,并在其放行前得以审核和批准。该批准(其中包括批准输出的人员的签字和日期)应当予以记录。

(e) Design review.设计审核

Each manufacturer shallestablish and maintain procedures to ensure that formal documented reviews ofthe design results are planned and conducted at appropriate stages of thedevice's design development. The procedures shall ensure that participants at eachdesign review include representatives of all functions concerned with thedesign stage being reviewed and an individual(s) who does not have directresponsibility for the design stage being reviewed, as well as any specialistsneeded. The results of a design review, including identification of the design,the date, and the individual(s) performing the review, shall be documented inthe design history file (the DHF).

每个制造商应当建立和维护一个规程用以保证在器械设计开发的相应阶段设计结果正式文件化的审核得以策划和实施。该规程应当保证在每次设计审核中的参与者都包括了设计阶段的所有职能的代表,在设计阶段中不负有直接责任的一些个人,以及所需的专家。设计审核的结果应当记录在设计历史文档中。这些结果包括设计识别、日期和实施审核的人员。

(f) Design verification.设计确认

Each manufacturer shallestablish and maintain procedures for verifying the device design. Designverification shall confirm that the design output meets the design inputrequirements. The results of the design verification, including identificationof the design, method(s), the date, and the individual(s) performing theverification, shall be documented in the DHF.

每个制造商应当建立和维护一个程序用于确认器械的设计。设计确认应当证明设计输出符合设计输入要求。设计确认的结果应当记录在设计历史文档中。这些结果包括设计识别、方法学、日期和实施审核的人员。

(g) Design validation.设计验证

Each manufacturer shallestablish and maintain procedures for validating the device design. Designvalidation shall be performed under defined operating conditions on initialproduction units, lots, or batches, or their equivalents. Design validationshall ensure that devices conform to defined user needs and intended uses andshall include testing of production units under actual or simulated useconditions. Design validation shall include software validation and riskanalysis, where appropriate. The results of the design validation, includingidentification of the design, method(s), the date, and the individual(s)performing the validation, shall be documented in the DHF.

每个制造商应当建立和维护一个程序用于验证器械的设计。设计验证应当在规定的条件下(最初的产品、批次或其等价物)进行。设计验证应当保证器械符合之前界定好的使用者需求和预期使用要求,设计验证应当包括在实际或等效的使用条件下的产品单元的测试。设计验证应当包括适当的软件验证和风险分析。包括设计的确定、方法学、日期、实施验证的人员的设计验证结果应当记录在设计历史文档中。

(h) Design transfer. 设计转换

Each manufacturer shall establish and maintain procedures toensure that the device design is correctly translated into productionspecifications.

每个制造商应当建立和维护一个程序来保证器械设计正确的转换成产品标准。

(i) Design changes.设计变更

Each manufacturer shallestablish and maintain procedures for the identification, documentation,validation or where appropriate verification, review, and approval of designchanges before their implementation.

每个制造商应当建立和维护一个程序在变更实施前用以对设计变更进行相应的识别、记录、验证或相应的确认、审核和批准。

(j) Design history file.设计历史文档

Each manufacturer shallestablish and maintain a DHF for each type of device. The DHF shall contain orreference the records necessary to demonstrate that the design was developed inaccordance with the approved design plan and the requirements of this part.

每个制造商应当为每个类型的器械建立和维护一个设计历史文档,该历史文档应当包括或涉及必须的记录来保证设计已经依据批准的设计方案和本章节的要求进行了相应的开发。

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