— the ability to adequately support and maintain the water purification equipment; — 支持和维护水纯化设备的能力
— the continuity of operational usage considering hours/days, days/years and planned downtime; — 操作连续性，考虑小时/天，天/年和计划停机时间
— the total life-cycle costs (capital and operational including maintenance). — 总生命周期成本（固定和操作，包括维保成本）
5.1.3 The specifications for water purification equipment, storage and distribution systems should take into account the following:
水纯化设备、存贮和分配系统的质量标准应考虑以下内容 — the location of the plant room; — 制水间位置
— extremes in temperature that the system will encounter; — 系统会遇到的极端温度
— the risk of contamination from leachates from contact materials; — 接触性材料浸出物污染风险
— the adverse impact of adsorptive contact materials; — 吸收性接触材料负面影响
— hygienic or sanitary design, where required; — 卫生或隔膜设计，需要时 — corrosion resistance; — 防腐蚀
— freedom from leakage; — 无泄漏
— a system configuration to avoid proliferation of microbiological organisms; — 避免微生物滋生的系统配置
— tolerance to cleaning and sanitizing agents (thermal and/or chemical);
— 对清洁和消毒剂的可接受性（热力和/或化学的） — the sanitization strategy; — 消毒策略
— the system capacity and output requirements; — 系统产能和输出要求
— the provision of all necessary instruments, test and sampling points to allow all the relevant
critical quality parameters of the complete system to be monitored.
— 所有必须的仪器、检测和取样点的设置，应使得所有与整个系统有关的关键质量参数可
以被监控
5.1.4 The design, configuration and layout of the water purification equipment, storage and distribution systems should also take into account the following physical considerations: 水纯化设备、存贮和分配系统的设计、配置和平面布置应考虑以下物理性因素 — ability to collect samples; — 采集样品的能力
— the space available for the installation; — 安装空间
— structural loadings on buildings; — 对建筑结构的负重
— the provision of adequate access for maintenance; — 进行维保的许可条款
— the ability to safely handle regeneration and sanitization chemicals. — 安全处理再生和消毒用化学品的能力 5.2 Production of drinking-water 饮用水的制备
5.2.1 Drinking-water is derived from a raw water source such as a well, river or reservoir. There are no prescribed methods for the treatment of raw water to produce drinking-water from a specific raw water source.
饮用水是从原水，如井水，河水或蓄水池制备而成的水。没有描述的方法用于从特定原水制备饮用水。
5.2.2 Typical processes employed at a user plant or by a water supply authority include: 使用者车间或制水供应商典型的处理包括 — desalinization; — 除盐 — filtration; — 过滤 — softening; — 软化
— disinfection or sanitization (e.g. by sodium hypochlorite (chlorine) injection); — 消毒或灭菌（例如，采用次氯酸钠（氯）注射液） — iron (ferrous) removal; — 除铁 — precipitation; — 沉淀
— reduction of concentration of specific inorganic and/or organic materials. — 减少特定的无机和/或有机物质
5.2.3 The drinking-water quality should be monitored routinely to account for environmental, seasonal or supply changes which have an impact on the source water quality.
饮用水质量应进行常规监控，应考虑环境、季节或供应变化可能对源水质量造成的影响。 5.2.4 Additional testing should be considered if there is any change in the raw water source, treatment techniques or system configuration.
如果水源、处理技术或系统参数有变化，应考虑增加检测。
5.2.5 Trend review may be used to identify changes. If the drinking-water quality changes significantly, but is still within specification, the direct use of this water as a WPU, or as the
feed-water to downstream treatment stages, should be reviewed and the result of the review documented.
应进行趋势分析以发现趋势。如果饮用水质量有显著变化，但仍在质量标准范围内，应审核作为WPU直接使用，或作为下游处理用源水的情况，审核结果应有书面记录。
5.2.6 Where drinking-water is derived from an ―in-house‖ system for the treatment of raw water, the water-treatment steps used and the system configuration should be documented. Changes to the system or to its operation should not be made until a review has been completed and the change approved by the QA department in accordance with change control procedures.
如果饮用水由公司内部对原水进行处理产生，则所使用的水处理步骤和系统配置应有记录。对该系统或其操作的变更只有在审核完成后，才能进行，变更应由QA部门根据变更控制程序批准。
5.2.7 Where drinking-water is stored and distributed by the user, the storage systems must not allow degradation of the water quality before use. After any such storage, testing should be carried out routinely in accordance with a defined method. Where water is stored, the system design and operation should ensure a turnover or recirculation of the stored water sufficient to prevent stagnation.
如果饮用水由使用者存贮并分发，则存贮系统必须保证水质量在使用前不会降低。在存贮之后，应根据定义的检测方法进行常规检测。如果水是被存贮的，系统设计和操作应保证所存贮的水的周转或循环足以防止死水。
5.2.8 The drinking-water system is usually considered to be an ―indirect impact system‖ and does not need to be qualified.
饮用水系统一般被认为是一个“间接产生影响系统”，不需要进行确认。
5.2.9 Drinking-water purchased in bulk and transported to the user by tanker has additional problems and risks not associated with drinking-water delivered by pipeline. Vendor assessment and authorized certification activities, including confirmation of the acceptability of the delivery vehicle, should be undertaken in a similar way to that used for any other starting material. 如果饮用水是散装采购，采用槽罐运至使用者处会有另外的问题和风险，这些问题是管道输送的饮用水所没有的。供应商评估和有资质的活性，包括对运输卡车的可接受性确认，均应采用与其它起始物料相似的方法进行。
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