c) business, organizational, and user requirements,　  
                        商业、组织或用户要求
                        d) safety, environmental, and security requirements,　  
                        安全、环境和可靠性要求
                        e) installability, usability, and maintainability
                        requirements,   安装性能，使用性能及维护性能要求
                        f) design constraints, and　   设计约束，等
                        g) testing requirements. [10]　   检测要求. [10]
                        7.3.2.H.1 Content of Requirements – The product
                        requirements shall include, but are not limited to:
                        7.3.2.H.1要求的内容－产品要求应包括，但不局限于：
                        a) nominal values and tolerances,　   名称、价格及公差
                        b) maintainability needs, and　   必须的可维修性等
                        c) end-item packaging requirements. [5]　   最终包装要求. [5]
                        7.3.2.S.1 Identification of Software Requirements – The
                        organization shall determine, analyze, and document the
                        software component requirements of the system. [10]
                        7.3.2.S.1 软件要求鉴定－组织应确定、分析、证明系统软件组建的要求。
                        7.3.2.S.2 Requirements Allocation – The organization
                        shall document the allocation of the product
                        requirements to the product architecture. [9]
                        7.3.2.s.2 要求分配－组织应编制文件将产品的要求分配到产品结构。[9]

                        7.3.3 Design and development outputs     设计和开发输出
                        设计和开发的输出应以能够针对设计和开发的输入进行验证的方式提出，并应在放行前得到批准。
                        设计和开发输出应：
                        a) 满足设计和开发输入的要求；
                        b) 给出采购、生产和服务提供适当的信息；
                        c) 包含或引用产品接收准则；
                        d) 规定对产品的安全和正常使用所必需的产品特性。
                        7.3.3.S.1 Software Design and Development Output –
                        Software design and development outputs should include,
                        but are not limited to: 软件设计和开发输出－软件设计和开发输出应包括（但不限于）：
                        a)     system architecture, 体系结构
                        b)     system detailed design, 系统详细设计
                        c)     source code, and源代码，和
                        d) user documentation. [9] 用户文件〔9〕
                        7.3.3.V.1 Services Design and Development Output – The
                        required output from the services design and development
                        shall contain a complete and precise statement of the
                        service to be provided. Design and development outputs
                        shall include, but are not limited to:
                        7.3.3.V.1
                        服务设计和开发输出－服务设计和开发的输出应包含完整的和精确的提供服务的阐述。设计和开发输出应包括（但不限于）：
                        a)     service delivery procedures, 服务传递程序
                        b) resource and skill requirements, 资源和能力要求
                        c) reliance on suppliers, 对供应商的信任
                        d) service characteristics subject to customer
                        evaluation, and服从于客户评估的服务特征
                        e) standards of acceptability for each service
                        characteristic. [13] 每个服务特征可接受性的标准
                        7.3.4 Design and development review   设计和开发评审
                        在适宜的阶段，应对依据所策划的安排（见7.3.1）设计和开发进行系统的评审，以便：
                        a) 评价设计和开发的结果满足要求的能力；
                        b) 识别任何问题并提出必要的措施。
                        评审的参加者应包括与所评审的设计和开发阶段有关的职能的代表，评审结果及任何必要措施的记录应予保持（见4.2.4）。
                        7.3.5 Design and development verification   设计和开发验证
                        为确保设计和开发输出满足输入的要求，应对依据所策划的安排（见7.3.1）设计和开发进行验证。验证结果及任何必要措施的记录应予保持（见4.2.4）。
                        7.3.6 Design and development validation   设计和开发确认
                        为确保产品能够满足规定的使用要求或已知预期用途的要求，应依据所策划的安排（见7.3.1）对设计和开发进行确认。只要可行，确认应在产品交付或实施之前完成。确认结果及任何必要措施的记录应予保持（见4.2.4）。
                        7.3.6.C-NOTE 1: Organizations should include customer(s)
                        or a third party during various validation stages, as
                        appropriate.
                        7.3.6.C－注1：恰当地说，在不同的确认阶段组织应该包括客户或第三方。
                        7.3.6.S.1 Release Management – The organization shall
                        establish and maintain a documented
                        procedure(s) to control the release and delivery of
                        software products and documentation. The
                        documented procedure(s) should include methods to
                        provide for the following:
                        7.3.6.S.1
                        发行管理－组织应建立和维护一个程序文件去控制软件产品和文件的发行和分发。这个程序文件应包括下文提供的方法：
                        a) release planning information delivered to the
                        customer sufficiently in advance of the release,
                        发行规划信息（在发行之前充分发给客户的）
                        b) product introduction and release schedules to the
                        customer,
                        给客户的产品介绍和发行进度表
                        c) detailed descriptions of product features delivered
                        and changes incorporated in new software
                        products or releases, and
                        产品特征的详细说明和新软件或发行中的变化
                        d) advising the customer of current or planned changes.
                        [11]
                        建议客户目前的或计划的变化