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ISO13485-2016中英文对照 产品实现(7.6)

文章来源: 深圳博凌管理技术有限公司 人气:411 发表时间:2022-12-28 16:13:35

7.6 Controlof monitoring and measuring equipment 监控和测量设备的控制


The organizationshall determine the monitoring and measurement to be undertaken and the monitoringand measuring equipment needed to provide evidence of conformity of product to determinedrequirements.

组织应当确定所需实施监控和测量,以及应用的设备以便于提供符合产品特定要求的证据。


The organizationshall document procedures to ensure that monitoring and measurement can be carriedout and are carried out in a manner that is consistent with the monitoring andmeasurement requirements.

组织应当形成程序文件来保证监控和测量的实施,并与监控和测量需求相一致的方式进行。


As necessary toensure valid results, measuring equipment shall:

为了保证结果有效,测量设备应当:


a) be calibratedor verified, or both, at specified intervals, or prior to use, againstmeasurement standards traceable to international or national measurementstandards: when no such standards exist, the basis used for calibration orverification shall be recorded (see 4.2.5);

在指定的时间间隔或使用之前进行校准或确认,或两个都进行。测量标准应能溯源到国际或国家测量标准:如果没有相应的标准,用于校准或确认的依据应当进行记录(见4.2.5);


b) be adjustedor re-adjusted as necessary: such adjustments or re-adjustments shall berecorded (see 4.2.5);

必要进行调整或再调整:调整或重新调整应进行记录(见4.2.5);(新增)


c) haveidentification in order to determine its calibration status;

得到识别用以确定其校准状态;


d) besafeguarded from adjustments that would invalidate the measurement result;

应防止可能使测量结果失效的调整;


e) be protectedfrom damage and deterioration during handling, maintenance and storage.

在处理、维护和存储期间应保护设备免受危害和退化;


The organizationshall perform calibration or verification in accordance with documentedprocedures.

组织应当依据批准的程序实施校准或确认。


In addition, theorganization shall assess and record the validity of the previous measuringresults when the equipment is found not to conform to requirements. Theorganization shall take appropriate action in regard to the equipment and anyproduct affected.

另外,当发现设备不符合要求时,组织应当评价和记录以往的测量结果。组织应当对受影响的设备和产品采取相应的措施。


Records of theresults of calibration and verification shall be maintained (see 4.2.5).

校准和确认结果的记录应当予以保留(见4.2.5)。


The organizationshall document procedures for the validation of the application of computersoftware used for the monitoring and measurement of requirements. Such softwareapplications shall be validated prior to initial use and, as appropriate, afterchanges to such software or its application.

组织应当建立用于监控和测量需要的计算机软件应用验证程序,在使用之前应对其软件应用进行验证,相应的,在应用之后或其他变更时也要进行验证。(新增)


The specific approach and activitiesassociated with software validation and revalidation shall be proportionate to therisk associated with the use of the software, including the effect on theability of the product to conform to specifications. Records of the results andconclusion of validation and necessary actions from the validation shall be maintained(see 4.2.4 and 4.2.5).

与软件验证相关的措施和特定方法以及在验证应当与软件使用对应的风险相适应,包括符合标准产品能力的影响。验证的结论和结果以及由验证引伸出来的相关措施的记录都应当予以保留(见4.2.4和4.2.5)。(新增)


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