ISO13485-2016中英文对照(六)-产品实现7.3

7 Product realization7 产品实现7.3设计和开发7.3 Designand development 设计和开发7.3.1General 总则The organizationshall d

7 Product realization

7 产品实现

7.3设计和开发

7.3 Designand development 设计和开发

7.3.1General 总则

The organizationshall document procedures for design and development.

组织应当建立设计和开发程序文件。

章节性变化,YY/T0287原文在7.3.1项下。

7.3.2Design and development planning 设计和开发策划

The organizationshall plan and control the design and development of product. As appropriate,design and development planning documents shall be maintained and updated asthe design and development progresses.

组织应当策划和控制产品的设计和开发。随着设计和开发的开展,设计和开发的计划文件应适当的进行维护和更新。(新增)

During designand development planning, the organization shall document:

在设计和开发策划期间,组织应当文件化:

a) the design anddevelopment stages;

设计和开发的阶段

b) the review(s)needed at each design and development stage;

每个设计和开发阶段所需的审核;

c) theverification, validation, and design transfer activities that are appropriateat each design and development stage;

适用于每个设计和开发阶段的确认、验证和设计转换活动;

b)c)等同于YY/T0287b)

d) theresponsibilities and authorities for design and development;

设计和开发的职责和权限。

e) the methodsto ensure traceability of design and development outputs to design and

developmentinputs;

保证设计和开发输入和输出的追溯性的方法。(新增)

f) the resourcesneeded, including necessary competence of personnel.

所学的资源,包括必须的有经验的人员。(新增)

删剪掉YY/T0287c)项后所有内容。

7.3.3Design and development inputs 设计开发的输入

Inputs relatingto product requirements shall be determined and records maintained (see 4.2.5). These inputsshall include:

与产品需求相关的输入应当被确定,记录应当被保留。输入应当包括:

a) functional,performance, usability and safety requirements, according to the intended use;

功能性、操作性、可用性和安全性需求,依据预期的用途。

b) applicableregulatory requirements and standards;

适用的法律法规要求和标准;

c) applicable output(s)of risk management;

风险管理适用的输出

d) asappropriate, information derived from previous similar designs;

如果适用,来源于以往相同设计的信息;

e) otherrequirements essential for design and development of the product and processes.

针对产品和过程设计和开发所需的其他必要需求;(新增)

These inputsshall be reviewed for adequacy and approved.

应对这些输入的充分性进行审核,并批准。

Requirementsshall be complete, unambiguous, able to be verified or validated, and not inconflict with each other.

要求必须完整,明确,能够确认或验证,并不相互产生冲突。

NOTE Furtherinformation can be found in IEC 62366–1.

注:详细信息见IEC62366–1.

7.3.4Design and development outputs 设计和开发输出

Design anddevelopment outputs shall: 设计和开发输出应当包括:

a) meet theinput requirements for design and development;

符合设计和开发输入的要求;

b) provideappropriate information for purchasing, production and service provision;

提供适应的采购、生产和服务信息

c) contain orreference product acceptance criteria;

包含或涉及引用的可接收标准;

d) specify thecharacteristics of the product that are essential for its safe and proper use.

描述产品安全和正常使用所必须的产品特性。

The outputs ofdesign and development shall be in a form suitable for verification against thedesign and development inputs and shall be approved prior to release.

设计和开发的输出应当符合设计和开发的输入要求,并在最后放行前得到批准。(新增)

Records of thedesign and development outputs shall be maintained (see 4.2.5).

应保留设计和开发输出的记录。(详见4.2.5

7.3.5Design and development review 设计和开发审核

At suitablestages, systematic reviews of design and development shall be performed inaccordance with planned and documented arrangements to:

在适当的阶段,应当根据策划和文件化的安排实施系统的设计和开发审核。以便:

a) evaluate theability of the results of design and development to meet requirements;

评估设计和开发结果符合需求的能力;

b) identify andpropose necessary actions.

识别并提出必要的措施。

Participants insuch reviews shall include representatives of functions concerned with thedesign and development stage being reviewed, as well as other specialistpersonnel.

审核人员应当包括设计和开发阶职能部门人员和其他专业人员。

Records of theresults of the reviews and any necessary actions shall be maintained andinclude the identification of the design under review, the participantsinvolved and the date of the review (see 4.2.5)

审核结果和任何必要的措施的相关记录应当予以保留,记录中包括审核下的设计识别、相关人员、审核的日期。(新增)(见4.2.5

7.3.6Design and development verification 设计和开发的确认(YY/T0287翻译成验证)

Design anddevelopment verification shall be performed in accordance with planned anddocumented arrangements to ensure that the design and development outputs havemet the design and development input requirements.

设计和开发确认应当依据策划好的和文件化的方案来实施,从而保证设计和确认的输出能够符合设计和确认输入的要求。

The organizationshall document verification plans that include methods, acceptance criteriaand, as appropriate, statistical techniques with rationale for sample size.

组织应当建立确认计划,包括方法、接受标准、如果可以,样本大小的统计技术。(新增)

If the intendeduse requires that the medical device be connected to, or have an interfacewith, other medical device(s), verification shall include confirmation that thedesign outputs meet design inputs when so connected or interfaced.

如果医疗器械的预期用途与其他医疗器械相连或有接口,当这样相连或接口时,确认应当包括设计输出满足设计输入的证明。(新增)

Records of theresults and conclusions of the verification and necessary actions shall bemaintained (see 4.2.4 and 4.2.5).

所有确认结论和结果以及必要的措施的记录都应当予以保留。(见4.2.44.2.5

7.3.7Design and development validation 设计和开发的验证(YT/T0287翻译成确认)

Design anddevelopment validation shall be performed in accordance with planned anddocumented arrangements to ensure that the resulting product is capable ofmeeting the requirements for the specified application or intended use.

设计和开发验证应当依据策划好的和文件化的方案来实施,从而保证产品能够满足规适用要求或预期用途的要求。

The organizationshall document validation plans that include methods, acceptance criteria and,as appropriate, statistical techniques with rationale for sample size.

组织应当建立验证计划包括方法、接受标准、如果可以,样本大小的统计技术。(新增)

Design validation shall beconducted on representative product. Representative product includes initial production units, batches or their equivalents.The rationale for the choice of product used for validation shall be recorded(see 4.2.5).

设计验证应当用代表性的产品加以实施。代表性的产品包括初始产品单位、批量或其等价物。应当记录选择用于验证产品的统计技术。(见4.2.5

As part ofdesign and development validation, the organization shall perform clinicalevaluations or performance evaluations of the medical device in accordance withapplicable regulatory requirements.

作为设计和开发验证的一部分,组织应当一句相应的法律法规实施临床评价或性能评价。

A medical deviceused for clinical evaluation or performance evaluation is not considered to bereleased for use to the customer.

用于临床评价或性能评价的医疗器械不可以放行为客户使用。

If the intendeduse requires that the medical device be connected to, or have an interfacewith, other medical device(s), validation shall include confirmation that therequirements for the specified application or intended use have been met whenso connected or interfaced.

如果医疗器械的预期用途与其他医疗器械相连或有接口,当这样相连或接口时,验证应当包括使用要求和预期用途已经得到符合的证明。(新增)

Validation shallbe completed prior to release for use of the product to the customer.

Records of theresults and conclusion of validation and necessary actions shall be maintained(see 4.2.4 and 4.2.5).

在产品交付使用者之前验证应当实施完,验证的结果及任何必要措施的记录应予保留(见4.2.44.2.5)。

7.3.8 Design and development transfer 设计和开发的转换

The organizationshall document procedures for transfer of design and development outputs to manufacturing.These procedures shall ensure that design and development outputs are verified assuitable for manufacturing before becoming final production specifications andthat production capability can meet product requirements.

组织应当建立设计和开发输出到实现产品之间的转换程序。这些程序应当保证设计和开发输出得以证实,并在产品成为最终产品规格时适合于生产制造,并且产能与产品要求相适应。

Results andconclusions of the transfer shall be recorded (see 4.2.5).

转换的结论和结果应当予以记录(见4.2.5)。(新增)

7.3.9 Control of design and development changes 设计和开发变更的控制

The organizationshall document procedures to control design and development changes. The organizationshall determine the significance of the change to function, performance,usability, safety and applicable regulatory requirements for the medical deviceand its intended use.

组织应当建立程序来控制设计和开发的变更。组织应当确定医疗器械的功能、操作、可用性、安全性和适当的法规要求和它的预期用途变更的重要性。

Design anddevelopment changes shall be identified. Before implementation, the changesshall be:

设计和开发变更应当被确定。在实施前,变更应当:

a) reviewed; 再审核

b) verified;确认

c) validated, asappropriate;适当的验证;

d) approved.批准。

The review ofdesign and development changes shall include evaluation of the effect of thechanges on constituent parts and product in process or already delivered,inputs or outputs of risk management and product realization processes.

设计和开发变更的审核应当包括这些变更所产生的影响。这些变更包括过程中和已经交付产品和组件的变更、风险管理的输入和输出以及产品实现过程的变更。

Records ofchanges, their review and any necessary actions shall be maintained (see 4.2.5).

变更,变更的审核和任何必须的措施的记录都应当予以保留(见4.2.5

7.3.10 Design and development files 设计和开发文档

The organizationshall maintain a design and development file for each medical device type ormedical device family. This file shall include or reference records generatedto demonstrate conformity to the requirements for design and development and records for design anddevelopment changes.

组织应当为每一个医疗器械或系列医疗器械保留一份设计和开发文档。该文档应当包括或涉及相应的记录。这些记录包含符合设计和开发要求的证明文件以及设计和开发变更的相关记录。(新增)

备注:翻译有不到的地方请见谅,针对Design and development verification and

Designand development validation笔者一直认为两个定义部分中“verification”应当翻译为确认而“validation”应当翻译为验证。但由于这两个词又都有确认和验证之意,所以还望以最后的官方译文为准,谢谢。

总结:产品实现7.3设计和开发控制变化还是比较明显的。其中几个重要的部分是。增加了7.3.8设计转换(设计和开发的转换)和7.3.10设计和开发文档(Design and developmentfiles);7.3.9设计和开发变更,有大篇幅的更改。7.3.67.3.7设计开发确认和验证部分也都有明显的增加内容。7.3.2-7.3.5都有一点新增内容,希望大家多关注。

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