ISO13485-2016中英文對照 產品實現（7.6）

7.6 Controlof monitoring and measuring equipment 監控和測量設備的控制

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.

組織應當確定所需實施監控和測量，以及應用的設備以便于提供符合產品特定要求的證據。

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.

組織應當形成程序文件來保證監控和測量的實施，并與監控和測量需求相一致的方式進行。

As necessary toensure valid results, measuring equipment shall:

為了保證結果有效，測量設備應當：

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);

在指定的時間間隔或使用之前進行校準或確認，或兩個都進行。測量標準應能溯源到國際或國家測量標準：如果沒有相應的標準，用于校準或確認的依據應當進行記錄（見4.2.5）；

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

必要進行調整或再調整：調整或重新調整應進行記錄（見4.2.5）；（新增）

c) haveidentification in order to determine its calibration status;

得到識別用以確定其校準狀態；

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

應防止可能使測量結果失效的調整；

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

在處理、維護和存儲期間應保護設備免受危害和退化；

The organizationshall perform calibration or verification in accordance with documentedprocedures.

組織應當依據批準的程序實施校準或確認。

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，當發現設備不符合要求時，組織應當評價和記錄以往的測量結果。組織應當對受影響的設備和產品采取相應的措施。

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

校準和確認結果的記錄應當予以保留（見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.

組織應當建立用于監控和測量需要的計算機軟件應用驗證程序，在使用之前應對其軟件應用進行驗證，相應的，在應用之后或其他變更時也要進行驗證。（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).

與軟件驗證相關的措施和特定方法以及在驗證應當與軟件使用對應的風險相適應，包括符合標準產品能力的影響。驗證的結論和結果以及由驗證引伸出來的相關措施的記錄都應當予以保留（見4.2.4和4.2.5）。（新增）