7 Product realization
7 产品实现
7.3 设计和开发
7.3 Designand development 设计和开发
7.3.1 General 总则
The organizationshall document procedures for design and development.
组织应当建立设计和开发程序文件。
章节性变化，YY/T0287原文在7.3.1项下。
7.3.2 Design and development planning 设计和开发策划
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.
组织应当策划和控制产品的设计和开发。随着设计和开发的开展，设计和开发的计划文件应适当的进行维护和更新。（新增）
During designand development planning, the organization shall document:
在设计和开发策划期间，组织应当文件化：
a) the design anddevelopment stages;
设计和开发的阶段
b) the review(s)needed at each design and development stage;
每个设计和开发阶段所需的审核;
c) theverification, validation, and design transfer activities that are appropriateat each design and development stage;
适用于每个设计和开发阶段的确认、验证和设计转换活动；
b)和c)等同于YY/T0287的b)。
d) theresponsibilities and authorities for design and development;
设计和开发的职责和权限。
e) the methodsto ensure traceability of design and development outputs to design and
developmentinputs;
保证设计和开发输入和输出的追溯性的方法。（新增）
f) the resourcesneeded, including necessary competence of personnel.
所学的资源，包括必须的有经验的人员。（新增）
删剪掉YY/T0287的c)项后所有内容。
7.3.3 Design and development inputs 设计开发的输入
Inputs relatingto product requirements shall be determined and records maintained (see 4.2.5). These inputsshall include:
与产品需求相关的输入应当被确定，记录应当被保留。输入应当包括：
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，依据预期的用途。
b) applicableregulatory requirements and standards;
适用的法律法规要求和标准；
c) applicable output(s)of risk management;
风险管理适用的输出
d) asappropriate, information derived from previous similar designs;
如果适用，来源于以往相同设计的信息；
e) otherrequirements essential for design and development of the product and processes.
针对产品和过程设计和开发所需的其他必要需求；（新增）
These inputsshall be reviewed for adequacy and approved.
应对这些输入的充分性进行审核，并批准。
Requirementsshall be complete, unambiguous, able to be verified or validated, and not inconflict with each other.
要求必须完整，明确，能够确认或验证，并不相互产生冲突。
NOTE Furtherinformation can be found in IEC 62366–1.
注：详细信息见IEC62366–1.
7.3.4 Design and development outputs 设计和开发输出
Design anddevelopment outputs shall: 设计和开发输出应当包括：
a) meet theinput requirements for design and development;
符合设计和开发输入的要求；
b) provideappropriate information for purchasing, production and service provision;
提供适应的采购、生产和服务信息
c) contain orreference product acceptance criteria;
包含或涉及引用的可接收标准；
d) specify thecharacteristics of the product that are essential for its safe and proper use.
描述产品安全和正常使用所必须的产品特性。
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.
设计和开发的输出应当符合设计和开发的输入要求，并在最后放行前得到批准。（新增）
Records of thedesign and development outputs shall be maintained (see 4.2.5).
应保留设计和开发输出的记录。（详见4.2.5）
7.3.5 Design and development review 设计和开发审核
At suitablestages, systematic reviews of design and development shall be performed inaccordance with planned and documented arrangements to:
在适当的阶段，应当根据策划和文件化的安排实施系统的设计和开发审核。以便：
a) evaluate theability of the results of design and development to meet requirements;
评估设计和开发结果符合需求的能力；
b) identify andpropose necessary actions.
识别并提出必要的措施。
Participants insuch reviews shall include representatives of functions concerned with thedesign and development stage being