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ISO13485认证辅导---ISO13485-2016中英文对照 产品实现(7.3.6~7.3.8)

7.3.6 Design 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4.2.4和4.2.5)


7.3.7 Design 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4.2.4和4.2.5)。


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)


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