Design verification shall confirm that the design output meets the design input requirements.
设计验证应当证明设计输出符合设计输入的要求。
Is the design output documented and expressed in terms that can be validated against the design input requirements?
设计输出有被记录在案，并可以验证针对设计输入的要求吗？
Design output shall be documented and expressed in terms that can be verified and validated against design input requirements.
设计输出应予文件化，并以对设计输入要求能被查证及作有效性确认方式予以表达。
The product design output shall be expressed in terms that can be verified and validated against product design input requirements.
产品设计输出，应以能够对照设计输入要求，进行验证和确认的形式来表达。
The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated.
制造过程设计输出，应以能够对照设计输入要求，进行验证和确认的形式来表达。
The organization shall identify, document and review the manufacturing process design input requirements, including targets for productivity, process capability and cost.
组织必须识别制造过程设计输入要求，形成文件并进行评审，包括以下内容：生产率，过程能力和成本的目标。
A set of design input requirements, when converted to engineering terminology, finalized and accepted as part of the device master record is called a device or product specification.
当设计成套的输入的规定被转换成工程术语，并在器械主记录中得到最终确认并成为记录一部分，这些成套规定就被称之为器械或产品规格。
Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements.
每个制造商应当确定和维护一个程序，用于界定和记录设计输出，从而给予一个符合设计输入要求的充分评估。
Documents based on these templates may be created and managed alongside the formal models, providing the requirements input needed to drive analysis and design threads.
除了规范化模型以外，还可能创建和管理基于这些模板的文档，以提供驱动分析和设计思路所需的需求输入。
The bulk of the design work becomes defining the set of components needed to meet the system requirements and the input/output messages that each component needs to handle.
多半设计工作就是，定义满足系统需求所需的组件集和每个组件需要处理的输入/输出消息。
These external needs and expectations, coupled with those internal to the organization, should be suitable for translation into input requirements for the design and development processes.
这些外部的需求和期望与组织内部的需求和期望都应当适合于转化为设计和开发过程的输入要求。
Under a design control system, manufacturers should identify device requirements during the design input phase or beginning of the design activity.
在设计控制体系下，生产商应该在设计输入阶段或者设计活动的开始就识别器械规定。
As for incomplete, vague or contradictory requirements, the team leader should discuss with required responsible departments to solve them, and keep the result in product design input report.
对不完整的、含糊的、或矛盾的要求，应在设计前与要求的责任单位共同协商解决，其结果记录于《设计评审报告》中。
A documented device specification or set of specifications derived from the input requirements should exist at the beginning of the physical design project.
在实物设计工程的初期应该具有由输入规定衍生而来的成文的器械规格或成套的规格。
Design input includes determining customer needs, expectations and requirements plus determining regulatory, standards, and other appropriate requirements.
设计输入包括确定消费者需求、期望和要求，以及明确法规、标准和其他适合的规定。
Input motion screw and output motion screw are applied to represent design specification as well as kinematic behavior requirements.
通过输入运动旋量和输出运动旋量表达机构的运动行为要求和设计需求。
At appropriate stages of design, design verification shall be performed to ensure that the design stage output meets the design stage input requirements.
在设计过程中之适当阶段，应实施设计查证，以确保设计阶段之输出能符合其设计输入要求。
At appropriate stages of design, design verification shall be performed to ensure that the design stage output meets the design stage input requirements.
在设计过程中之适当阶段，应实施设计查证，以确保设计阶段之输出能符合其设计输入要求。
应用推荐