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7.3.6 Design and development verification 設(shè)計(jì)和開發(fā)的確認(rèn)（YY/T0287翻譯成驗(yàn)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(shè)計(jì)和開發(fā)確認(rèn)應(yīng)當(dāng)依據(jù)策劃好的和文件化的方案來(lái)實(shí)施，從而保證設(shè)計(jì)和確認(rèn)的輸出能夠符合設(shè)計(jì)和確認(rèn)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(yīng)當(dāng)建立確認(rèn)計(jì)劃，包括方法、接受標(biāo)準(zhǔn)、如果可以，樣本大小的統(tǒng)計(jì)技術(shù)。（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(yī)療器械的預(yù)期用途與其他醫(yī)療器械相連或有接口，當(dāng)這樣相連或接口時(shí)，確認(rèn)應(yīng)當(dāng)包括設(shè)計(jì)輸出滿足設(shè)計(jì)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(rèn)結(jié)論和結(jié)果以及必要的措施的記錄都應(yīng)當(dāng)予以保留。（見(jiàn)4.2.4和4.2.5）

7.3.7 Design and development validation 設(shè)計(jì)和開發(fā)的驗(yàn)證（YT/T0287翻譯成確認(rèn)）

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(shè)計(jì)和開發(fā)驗(yàn)證應(yīng)當(dāng)依據(jù)策劃好的和文件化的方案來(lái)實(shí)施，從而保證產(chǎn)品能夠滿足規(guī)適用要求或預(yù)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(yīng)當(dāng)建立驗(yàn)證計(jì)劃包括方法、接受標(biāo)準(zhǔn)、如果可以，樣本大小的統(tǒng)計(jì)技術(shù)。（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(shè)計(jì)驗(yàn)證應(yīng)當(dāng)用代表性的產(chǎn)品加以實(shí)施。代表性的產(chǎn)品包括初始產(chǎn)品單位、批量或其等價(jià)物。應(yīng)當(dāng)記錄選擇用于驗(yàn)證產(chǎn)品的統(tǒng)計(jì)技術(shù)。（見(jiàn)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(shè)計(jì)和開發(fā)驗(yàn)證的一部分，組織應(yīng)當(dāng)一句相應(yīng)的法律法規(guī)實(shí)施臨床評(píng)價(jià)或性能評(píng)價(jià)。

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

用于臨床評(píng)價(jià)或性能評(píng)價(jià)的醫(yī)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(yī)療器械的預(yù)期用途與其他醫(yī)療器械相連或有接口，當(dāng)這樣相連或接口時(shí)，驗(yàn)證應(yīng)當(dāng)包括使用要求和預(yù)期用途已經(jīng)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(chǎn)品交付使用者之前驗(yàn)證應(yīng)當(dāng)實(shí)施完，驗(yàn)證的結(jié)果及任何必要措施的記錄應(yīng)予保留（見(jiàn)4.2.4和4.2.5）。

7.3.8 Design and development transfer 設(shè)計(jì)和開發(fā)的轉(zhuǎn)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(yīng)當(dāng)建立設(shè)計(jì)和開發(fā)輸出到實(shí)現(xiàn)產(chǎn)品之間的轉(zhuǎn)換程序。這些程序應(yīng)當(dāng)保證設(shè)計(jì)和開發(fā)輸出得以證實(shí)，并在產(chǎn)品成為最終產(chǎn)品規(guī)格時(shí)適合于生產(chǎn)制造，并且產(chǎn)能與產(chǎn)品要求相適應(yīng)。

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

轉(zhuǎn)換的結(jié)論和結(jié)果應(yīng)當(dāng)予以記錄（見(jiàn)4.2.5）。（新增）