7 Product realization
7 產(chǎn)品實(shí)現(xiàn)
7.3 設(shè)計(jì)和開(kāi)發(fā)
7.3 Designand development 設(shè)計(jì)和開(kāi)發(fā)
7.3.1 General 總則
The organizationshall document procedures for design and development.
組織應(yīng)當(dāng)建立設(shè)計(jì)和開(kāi)發(fā)程序文件。
章節(jié)性變化，YY/T0287原文在7.3.1項(xiàng)下。
7.3.2 Design and development planning 設(shè)計(jì)和開(kāi)發(fā)策劃
The organizationshall plan and control the design and development of product. As appropriate,design and development planning documents shall be maintained and updated asthe design and development progresses.
組織應(yīng)當(dāng)策劃和控制產(chǎn)品的設(shè)計(jì)和開(kāi)發(fā)。隨著設(shè)計(jì)和開(kāi)發(fā)的開(kāi)展，設(shè)計(jì)和開(kāi)發(fā)的計(jì)劃文件應(yīng)適當(dāng)?shù)倪M(jìn)行維護(hù)和更新。（新增）
During designand development planning, the organization shall document:
在設(shè)計(jì)和開(kāi)發(fā)策劃期間，組織應(yīng)當(dāng)文件化：
a) the design anddevelopment stages;
設(shè)計(jì)和開(kāi)發(fā)的階段
b) the review(s)needed at each design and development stage;
每個(gè)設(shè)計(jì)和開(kāi)發(fā)階段所需的審核;
c) theverification, validation, and design transfer activities that are appropriateat each design and development stage;
適用于每個(gè)設(shè)計(jì)和開(kāi)發(fā)階段的確認(rèn)、驗(yàn)證和設(shè)計(jì)轉(zhuǎn)換活動(dòng)；
b)和c)等同于YY/T0287的b)。
d) theresponsibilities and authorities for design and development;
設(shè)計(jì)和開(kāi)發(fā)的職責(zé)和權(quán)限。
e) the methodsto ensure traceability of design and development outputs to design and
developmentinputs;
保證設(shè)計(jì)和開(kāi)發(fā)輸入和輸出的追溯性的方法。（新增）
f) the resourcesneeded, including necessary competence of personnel.
所學(xué)的資源，包括必須的有經(jīng)驗(yàn)的人員。（新增）
刪剪掉YY/T0287的c)項(xiàng)后所有內(nèi)容。
7.3.3 Design and development inputs 設(shè)計(jì)開(kāi)發(fā)的輸入
Inputs relatingto product requirements shall be determined and records maintained (see 4.2.5). These inputsshall include:
與產(chǎn)品需求相關(guān)的輸入應(yīng)當(dāng)被確定，記錄應(yīng)當(dāng)被保留。輸入應(yīng)當(dāng)包括：
a) functional,performance, usability and safety requirements, according to the intended use;
功能性、操作性、可用性和安全性需求，依據(jù)預(yù)期的用途。
b) applicableregulatory requirements and standards;
適用的法律法規(guī)要求和標(biāo)準(zhǔn)；
c) applicable output(s)of risk management;
風(fēng)險(xiǎn)管理適用的輸出
d) asappropriate, information derived from previous similar designs;
如果適用，來(lái)源于以往相同設(shè)計(jì)的信息；
e) otherrequirements essential for design and development of the product and processes.
針對(duì)產(chǎn)品和過(guò)程設(shè)計(jì)和開(kāi)發(fā)所需的其他必要需求；（新增）
These inputsshall be reviewed for adequacy and approved.
應(yīng)對(duì)這些輸入的充分性進(jìn)行審核，并批準(zhǔn)。
Requirementsshall be complete, unambiguous, able to be verified or validated, and not inconflict with each other.
要求必須完整，明確，能夠確認(rèn)或驗(yàn)證，并不相互產(chǎn)生沖突。
NOTE Furtherinformation can be found in IEC 62366–1.
注：詳細(xì)信息見(jiàn)IEC62366–1.
7.3.4 Design and development outputs 設(shè)計(jì)和開(kāi)發(fā)輸出
Design anddevelopment outputs shall: 設(shè)計(jì)和開(kāi)發(fā)輸出應(yīng)當(dāng)包括：
a) meet theinput requirements for design and development;
符合設(shè)計(jì)和開(kāi)發(fā)輸入的要求；
b) provideappropriate information for purchasing, production and service provision;
提供適應(yīng)的采購(gòu)、生產(chǎn)和服務(wù)信息
c) contain orreference product acceptance criteria;
包含或涉及引用的可接收標(biāo)準(zhǔn)；
d) specify thecharacteristics of the product that are essential for its safe and proper use.
描述產(chǎn)品安全和正常使用所必須的產(chǎn)品特性。
The outputs ofdesign and development shall be in a form suitable for verification against thedesign and development inputs and shall be approved prior to release.
設(shè)計(jì)和開(kāi)發(fā)的輸出應(yīng)當(dāng)符合設(shè)計(jì)和開(kāi)發(fā)的輸入要求，并在最后放行前得到批準(zhǔn)。（新增）
Records of thedesign and development outputs shall be maintained (see 4.2.5).
應(yīng)保留設(shè)計(jì)和開(kāi)發(fā)輸出的記錄。（詳見(jiàn)4.2.5）
7.3.5 Design and development review 設(shè)計(jì)和開(kāi)發(fā)審核
At suitablestages, systematic reviews of design and development shall be performed inaccordance with planned and documented arrangements to:
在適當(dāng)?shù)碾A段，應(yīng)當(dāng)根據(jù)策劃和文件化的安排實(shí)施系統(tǒng)的設(shè)計(jì)和開(kāi)發(fā)審核。以便：
a) evaluate theability of the results of design and development to meet requirements;
評(píng)估設(shè)計(jì)和開(kāi)發(fā)結(jié)果符合需求的能力；
b) identify andpropose necessary actions.
識(shí)別并提出必要的措施。
Participants insuch reviews shall include representatives of functions concerned with thedesign and development stage being