7 Product realization
7 產品實現
7.3 設計和開發
7.3 Designand development 設計和開發
7.3.1 General 總則
The organizationshall document procedures for design and development.
組織應當建立設計和開發程序文件。
章節性變化，YY/T0287原文在7.3.1項下。
7.3.2 Design and development planning 設計和開發策劃
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.
組織應當策劃和控制產品的設計和開發。隨著設計和開發的開展，設計和開發的計劃文件應適當的進行維護和更新。（新增）
During designand development planning, the organization shall document:
在設計和開發策劃期間，組織應當文件化：
a) the design anddevelopment stages;
設計和開發的階段
b) the review(s)needed at each design and development stage;
每個設計和開發階段所需的審核;
c) theverification, validation, and design transfer activities that are appropriateat each design and development stage;
適用于每個設計和開發階段的確認、驗證和設計轉換活動；
b)和c)等同于YY/T0287的b)。
d) theresponsibilities and authorities for design and development;
設計和開發的職責和權限。
e) the methodsto ensure traceability of design and development outputs to design and
developmentinputs;
保證設計和開發輸入和輸出的追溯性的方法。（新增）
f) the resourcesneeded, including necessary competence of personnel.
所學的資源，包括必須的有經驗的人員。（新增）
刪剪掉YY/T0287的c)項后所有內容。
7.3.3 Design and development inputs 設計開發的輸入
Inputs relatingto product requirements shall be determined and records maintained (see 4.2.5). These inputsshall include:
與產品需求相關的輸入應當被確定，記錄應當被保留。輸入應當包括：
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，依據預期的用途。
b) applicableregulatory requirements and standards;
適用的法律法規要求和標準；
c) applicable output(s)of risk management;
風險管理適用的輸出
d) asappropriate, information derived from previous similar designs;
如果適用，來源于以往相同設計的信息；
e) otherrequirements essential for design and development of the product and processes.
針對產品和過程設計和開發所需的其他必要需求；（新增）
These inputsshall be reviewed for adequacy and approved.
應對這些輸入的充分性進行審核，并批準。
Requirementsshall be complete, unambiguous, able to be verified or validated, and not inconflict with each other.
要求必須完整，明確，能夠確認或驗證，并不相互產生沖突。
NOTE Furtherinformation can be found in IEC 62366–1.
注：詳細信息見IEC62366–1.
7.3.4 Design and development outputs 設計和開發輸出
Design anddevelopment outputs shall: 設計和開發輸出應當包括：
a) meet theinput requirements for design and development;
符合設計和開發輸入的要求；
b) provideappropriate information for purchasing, production and service provision;
提供適應的采購、生產和服務信息
c) contain orreference product acceptance criteria;
包含或涉及引用的可接收標準；
d) specify thecharacteristics of the product that are essential for its safe and proper use.
描述產品安全和正常使用所必須的產品特性。
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.
設計和開發的輸出應當符合設計和開發的輸入要求，并在最后放行前得到批準。（新增）
Records of thedesign and development outputs shall be maintained (see 4.2.5).
應保留設計和開發輸出的記錄。（詳見4.2.5）
7.3.5 Design and development review 設計和開發審核
At suitablestages, systematic reviews of design and development shall be performed inaccordance with planned and documented arrangements to:
在適當的階段，應當根據策劃和文件化的安排實施系統的設計和開發審核。以便：
a) evaluate theability of the results of design and development to meet requirements;
評估設計和開發結果符合需求的能力；
b) identify andpropose necessary actions.
識別并提出必要的措施。
Participants insuch reviews shall include representatives of functions concerned with thedesign and development stage being