7.3.6 Design and development verification 設計和開發的確認（YY/T0287翻譯成驗證）

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.

設計和開發確認應當依據策劃好的和文件化的方案來實施，從而保證設計和確認的輸出能夠符合設計和確認輸入的要求。

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

組織應當建立確認計劃，包括方法、接受標準、如果可以，樣本大小的統計技術。（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.

如果醫療器械的預期用途與其他醫療器械相連或有接口，當這樣相連或接口時，確認應當包括設計輸出滿足設計輸入的證明。（新增）

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

所有確認結論和結果以及必要的措施的記錄都應當予以保留。（見4.2.4和4.2.5）

7.3.7 Design and development validation 設計和開發的驗證（YT/T0287翻譯成確認）

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.

設計和開發驗證應當依據策劃好的和文件化的方案來實施，從而保證產品能夠滿足規適用要求或預期用途的要求。

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

組織應當建立驗證計劃包括方法、接受標準、如果可以，樣本大小的統計技術。（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).

設計驗證應當用代表性的產品加以實施。代表性的產品包括初始產品單位、批量或其等價物。應當記錄選擇用于驗證產品的統計技術。（見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.

作為設計和開發驗證的一部分，組織應當一句相應的法律法規實施臨床評價或性能評價。

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

用于臨床評價或性能評價的醫療器械不可以放行為客戶使用。

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.

如果醫療器械的預期用途與其他醫療器械相連或有接口，當這樣相連或接口時，驗證應當包括使用要求和預期用途已經得到符合的證明。（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).

在產品交付使用者之前驗證應當實施完，驗證的結果及任何必要措施的記錄應予保留（見4.2.4和4.2.5）。

7.3.8 Design and development transfer 設計和開發的轉換

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.

組織應當建立設計和開發輸出到實現產品之間的轉換程序。這些程序應當保證設計和開發輸出得以證實，并在產品成為最終產品規格時適合于生產制造，并且產能與產品要求相適應。

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

轉換的結論和結果應當予以記錄（見4.2.5）。（新增）