ISO 14644-5: 2025《洁净室及相关控制环境：操作》发布！Part II，各企业注意啦！
书接上回：重磅，ISO 14644-5: 2025《洁净室及相关控制环境：操作》发布！
8 Monitoring programme 监测计划
A monitoring programme shall be considered to demonstrate that the OCP with its materials flow, personnel management, cleaning, and maintenance programmes are followed and effective. Monitoring can include auditing, inspection, and measurement.
应考虑制定监测计划，以证明洁净室运行控制程序（OCP）及其物料流、人员管理、清洁和维护计划得到遵守且有效。监测可包括审核、检查和测量。
The performance of the cleanroom can be demonstrated by environmental monitoring. The monitoring program evaluates if cleanroom specified limits are maintained. Evaluate incidents where specified limits are exceeded.
洁净室的性能可通过环境监测来证明。监测计划用于评估洁净室是否维持在规定的限度内。应对超出规定限度的情况进行评估。
Methods for setting up environmental monitoring for air cleanliness are described in ISO 14644- 2, ISO 14644- 17 and the ISO 14698 series, if applicable. Testing of installation parameters are described in ISO 14644- 3.
设置空气洁净度环境监测的方法在ISO 14644-2、ISO 14644-17以及（如适用）ISO 14698系列标准中有相关描述。安装参数的测试在ISO 14644-3中进行了说明。
Where specified limits for cleanroom surface cleanliness are required, surfaces shall be monitored to evaluate whether the surface contamination is within the specified limits in accordance with ISO 14644- 9 for particles and ISO 14644- 10 for chemicals. Further, the performance of essential process parameters and utilities can be monitored.
当需要对洁净室表面洁净度规定限值时，应依据ISO 14644-9（针对颗粒物）和ISO 14644-10（针对化学品）对表面进行监测，以评估表面污染是否在规定限值内。此外，还可对关键工艺参数和公用设施的性能进行监测。
Monitoring can be automated or manual. Records of monitoring observations and data should be maintained based on industry requirements. Analysis of monitoring data is recommended for evaluation and potential improvement of the programmes.
监测可以是自动化或手动的。应根据行业要求保存监测观察结果和数据的记录。建议对监测数据进行分析，以评估相关计划并寻找潜在的改进空间。
NOTE A data system platform that organizes data from various sources can be used to collect and analyse monitoring information.
注：可使用一个组织来自各种来源数据的数据系统平台来收集和分析监测信息。
Annex A (informative)
Personnel management人员管理
A.1 Impact assessment 影响评估
A.1 It is essential that assigned persons complete an impact assessment (see clause 6) and develop operational procedures with regards to cleanroom personnel based on that assessment. Understanding contamination risks and sources for cleanroom operations will guide requirements and operational procedures for all cleanroom personnel, and sufficiently inform personnel of necessary considerations while operating in the cleanroom environment.
指定人员必须完成影响评估（见第 6 条），并基于该评估制定与洁净室人员相关的操作程序。了解洁净室操作的污染风险和来源，将为所有洁净室人员的要求和操作程序提供指导，并充分告知人员在洁净室环境中操作时的必要注意事项。
A.2 Accountability 责任
Cleanroom personnel accountability should be considered in three main categories: discipline, conduct, and personal initiative. The establishment and execution of these categories is directly dependent on routine proper personnel training, sensitization to the responsibilities of working in a cleanroom, and the establishment of a personnel supported cleanroom culture.
洁净室人员的责任应从三个主要类别进行考量：纪律、行为和个人主动性。这些类别的建立与执行直接依赖于常规的人员适当培训、对洁净室工作责任的认知提升，以及建立一个人员所支持的洁净室文化。
Discipline refers to personnel adhering to operational procedures at all times, and under all operational circumstances. Personnel should maintain a high level of personal expectation to follow all cleanroom operations. If personnel do not demonstrate a high level of discipline, cleanroom management should consider appropriate retraining or other actions to improve personnel discipline for cleanroom operations. 纪律是指人员在任何时候、任何操作情况下都遵守操作程序。人员应保持高度的个人期望以遵循所有洁净室操作规范。如果人员未表现出高度的纪律性，洁净室管理层应考虑进行适当的再培训或采取其他措施，以提升人员在洁净室操作中的纪律性。 Conduct refers to personnel executing proper cleanroom discipline through action. All personnel should act in a manner that demonstrates proper operational knowledge and reduce contamination risk to the cleanroom environment. 行为是指人员通过行动执行适当的洁净室纪律。所有人员的行为方式应体现出正确的操作知识，并降低对洁净室环境的污染风险。 Personal initiative refers to personnel taking individual responsibility to maintain the operations and cleanroom environment. This creates an operational cleanroom with a mentality to support the operations and to act in good conscience at all times. 个人主动性是指人员主动承担维护洁净室运行及环境的责任。这有助于形成一种工作心态，即始终自觉支持洁净室运行并以负责任的态度行事，从而打造一个合规的洁净室操作环境。
A.3 Personal items 个人物品
Personal items, such as jewellery, that are commonly worn or used outside controlled environments (e.g., home, office, street), may cause cleanroom or product contamination and can tear or generally impact the barrier function of gloves and gowning. Cleanroom personnel should not use or apply a personal product (e.g., lotion, soap, cosmetic, fragrance) whose presence is not approved due to potential product contamination. Personal work items, such as cell phones and electronic devices, used for work activities, should be fully assessed for contamination risk and procedures should be in place to eliminate the risks.
个人物品（如首饰等通常在受控环境外——如家庭、办公室、街道等场所佩戴或使用的物品）可能导致洁净室或产品污染，还可能撕裂手套和洁净服或对其屏障功能产生普遍影响。洁净室人员不得使用或涂抹未获批准的个人用品（如乳液、肥皂、化妆品、香水等），以防对产品造成污染。用于工作活动的个人工作物品（如手机和电子设备），应全面评估其污染风险，并制定相应程序以消除风险。
Items included in the list below can impact cleanroom and processes and should not be allowed inside the cleanroom or gowning room:
以下清单中所列物品会对洁净室及生产工艺产生影响，不得带入洁净室或更衣室内：
personal care products, such as gels and lotions; 个人护理产品，如凝胶和乳液 food, chewing gum and beverages; 食品、口香糖及饮料； jewellery, including piercings on exposed skin, rings, earrings, necklaces, watch, bracelets and pins; 珠宝首饰，包括暴露皮肤上的穿刺饰品、戒指、耳环、项链、手表、手镯及别针； cosmetics, including but not limited to makeup base, eyeliner, eyelash makeup, false eyelashes, lipstick, eyebrow pencil, rouge, nail polish, false tan, temporary tattoos, and talcum powder; 化妆品，包括但不限于粉底、眼线笔、睫毛化妆品、假睫毛、口红、眉笔、胭脂、指甲油、人工美黑产品、临时纹身及滑石粉； perfumes or other strongly fragrant personal care items that can cause chemical contamination; 会导致化学污染的香水或其他具有强烈香味的个人护理用品； money; 钱 fibrous sweaters, boots or materials that shed; 会掉纤维的毛衣、靴子或材料； torn or ripped clothing. 破损或撕裂的衣物。
If a cleanroom requires use of an approved lotion for specific task functions (e.g., used in conjunction with an electrostatic discharge wrist strap to facilitate grounding), then the required lotion should be compatible with cleanroom cleanliness requirements in order to not adversely affect the cleanroom environment and product (7.3.1).
如果洁净室因特定作业功能需要使用经批准的乳液（例如，与静电放电腕带配合使用以促进接地），则所使用的乳液应符合洁净室洁净度要求，以免对洁净室环境和产品造成不利影响（7.3.1）。
A.4 Personal hygiene 个人卫生
Hygiene of all personnel is a critical component to maintaining cleanroom cleanliness, and it is imperative that all cleanroom personnel have good personal hygiene. Maintaining a base level of personnel hygiene leads to reduction of contamination introduced to the cleanroom upon personnel entry and operation execution.
所有人员的卫生状况是维持洁净室清洁度的关键要素，因此所有洁净室人员必须具备良好的个人卫生习惯。保持人员基本卫生水平，可减少人员进入洁净室及执行操作时引入的污染。
Maintaining good personal hygiene includes keeping dandruff and excessive skin oils under control. Such control may necessitate the use of gentle soaps or appropriate sanitizers prior to cleanroom entry.
保持良好的个人卫生包括控制头皮屑和过多的皮肤油脂。这种控制可能需要在进入洁净室前使用温和的肥皂或适当的消毒剂。
Fingernail length should not compromise the integrity of gloves.
指甲长度不应影响手套的完整性。
A policy for hair management, including facial hair, should be established and managed.
应制定并执行包括面部毛发在内的毛发管理政策。
Hand washing or hand sanitization, using the equipment provided and adhering to specified procedure is required for all personnel prior to entering a changing room.
所有人员在进入更衣室前，需使用规定的设备并按照指定程序进行洗手或手部消毒。
If personnel have a reported condition that can have a negative effect on the cleanliness levels and thus process or product, it may be necessary to reassign personnel who have such conditions to work outside the cleanroom until the condition normalises. In some cleanrooms, it may be required that personnel refrain from smoking or vaping for a specified period before entering.
如果有报告显示人员的身体状况会对洁净室的洁净度产生负面影响，进而影响生产工艺或产品，可能需要将此类人员重新调配至洁净室外工作，直至其身体状况恢复正常。在某些洁净室中，可能要求人员在进入前的特定时间段内禁止吸烟或使用电子烟。
After eating, smoking, or vaping and prior to entering the cleanroom, practice good oral hygiene.
进食、吸烟或使用电子烟后，进入洁净室前需做好口腔卫生。
A.5 Personnel access 人员通道
Cleanrooms are controlled environments that adhere to specific requirements for cleanliness levels and operations. Humans in a cleanroom can be one of the greatest contamination sources due to clothing, shedding skin cells, and lack of knowledge to operate appropriately in a controlled environment. Therefore, cleanroom access should be restricted to trained personnel who are essential to the cleanroom operations and product development.
洁净室是遵循特定洁净度等级和操作要求的受控环境。由于衣物、皮肤细胞脱落以及在受控环境中缺乏适当操作知识，洁净室内的人员可能成为最大的污染源之一。因此，洁净室的进入权限应仅限于接受过培训且对洁净室操作和产品研发必不可少的人员。
Any cleanroom visitors or specialized contractors should be escorted and supervised by trained personnel responsible for the product and cleanroom operations. All escorted visitors to the cleanroom should receive specific instructions prior to supervised entry into specific viewing areas.
任何洁净室访客或专业承包商均需由负责产品和洁净室操作的培训人员陪同及监督。所有需陪同进入洁净室的访客，在受监督进入特定参观区域前，应接受具体指示。
Annex B (informative)
Gowning 洁净服穿戴
B.1 General 总则
Personnel contributions to maintaining the cleanroom environment begin with the removal and storage of outdoor clothing and prohibited items before arrival in the changing room where selected cleanroom garments are allocated. It should be noted that the type of clothing worn under cleanroom garments can affect the dispersion of airborne particles and fibres, and the mobility of personal products can introduce contaminants from handling in the cleanroom or garment change environment. Therefore, guidance on the suitability of types of clothing worn under cleanroom garments helps reducing contamination sources, provides a consistent gowning procedure, and helps maintaining the cleanliness levels in changing rooms for cleanroom entry.
人员在维护洁净室环境方面的贡献始于进入更衣室之前，需先脱下并存放室外衣物及违禁物品，而后在更衣室领取指定的洁净室服装。需注意的是，洁净服内穿着的衣物类型会影响空气中颗粒物和纤维的扩散，而个人物品的携带可能会在洁净室或更衣环境中因接触而引入污染物。因此，针对洁净服内穿着衣物的适用性提供指导，有助于减少污染源、规范洁净服穿戴流程，并助力维持更衣室进入洁净室前的洁净度标准。
For some cleanroom operations, it may be necessary to provide cleanroom undergarments. If underclothing is provided, they should be made from closely woven, artificial fibres such as polyester for effective filtration of body contaminants. A method should be adopted to put on and remove clothing to minimize contamination of the outside of the cleanroom gowning, and to ensure contamination is not spread from the changing area. Several methods are acceptable depending on the design of the changing area and the standard of cleanliness of the cleanroom (ISO 14644- 1).
对于某些洁净室操作，可能需要提供洁净室内衣。如果提供内衣，其应采用紧密编织的人造纤维（如聚酯纤维）制成，以有效过滤身体污染物。应采用特定方法穿脱衣物，以最大程度减少对洁净服外层的污染，并确保污染物不会从更衣区域扩散。根据更衣区域的设计和洁净室的洁净度标准（ISO 14644-1），有几种可接受的操作方法。
In addition to clothing worn under the cleanroom garments, the procedure to properly don the cleanroom garments themselves should be documented, clearly communicated and understood. The basic requirement for any gowning process is to avoid cross contamination from under garment (e.g., clothing, skin and hair) to prevent cleanroom garment contamination prior to cleanroom entry. When de- gowning, the same basic requirement applies to prevent contaminating garment components that will be re- used. Gowning procedures are designed in a specific order, so as to contain contamination and mitigate spread of contamination.
除洁净服内穿着的衣物外，正确穿戴洁净服的流程也应形成文件记录，并确保相关人员清晰知晓和理解。任何洁净服穿戴流程的基本要求是避免来自内层衣物（如内穿衣物、皮肤及毛发）的交叉污染，以防止在进入洁净室前污染洁净服。脱卸洁净服时，同样需遵循基本要求，避免污染需重复使用的洁净服部件。洁净服穿戴流程按特定顺序设计，以控制污染并降低污染扩散风险。
B.2 Consideration for impact assessment 影响评估的考量因素
The following points should be considered to address the specific aspect of the gowning programme.
为解决洁净服穿戴方案的特定方面问题，应考虑以下要点。
Ensure outline of the gowning procedure is appropriate for product, process, and operation of the cleanroom to specified cleanliness levels. 确保洁净服穿戴流程的概要适用于洁净室的产品、工艺及操作，并符合规定的洁净度等级要求。 Select appropriate personnel apparel i.e., material, size, sufficient supply following ISO 14644-18. 根据ISO 14644-18标准，选择合适的人员服装，即材料、尺寸合适且供应充足。 Determine gown assessment and laundry repair procedures. 确定洁净服评估及洗衣修复程序。 Determine the usage duration for garment before processing. 确定洁净服在处理前的使用时长。 Determine the service life for the garment. 确定洁净服的使用期限。
B.3 Gowning Procedure 洁净服穿戴程序
Given the criticality of gowning, an example for consideration of gowning procedure and reasons to understand garment donning operations are given here.
鉴于洁净服穿戴的重要性，此处提供一个关于洁净服穿戴流程的参考示例及理解穿戴操作原因的说明。
The following list outlines an example which can be customized to meet the specific operation needs identified in the impact assessment (clause 6).
以下列表概述了一个示例，可根据影响评估（第6条）中确定的特定操作需求进行定制。
Remove unnecessary street clothing (e.g., jackets, sweaters, hats) outside of the changing room. 在更衣室之外脱下不必要的日常衣物（如夹克、毛衣、帽子）。 Cleanroom personnel should wear appropriate clothing before proceeding into a changing area to don cleanroom garments. In order to reduce contact transfer and cross contamination, skin and clothing worn under cleanroom garments should not be touched once the gowning process is complete. 洁净室人员在进入更衣室穿戴洁净服之前，应穿着合适的衣物。为减少接触转移和交叉污染，洁净服穿戴流程完成后，不应再触碰洁净服内的皮肤及衣物。 Put on a hair cover and ensure all strands of hair are restrained by the cover to prevent hair shedding. If a cleanroom procedure requires it, put on a facial hair cover followed by a face mask.
戴上发帽，并确保所有头发都被发帽包裹，以防止头发脱落。如果洁净室规程有要求，先戴胡须罩，再戴口罩。
Put on disposable shoe covers or use designated cleanroom shoes for entering the gowning areas and subsequent cleanroom.
穿上一次性鞋套或使用指定的洁净室鞋子，以进入更衣区及后续的洁净室。
Most cleanroom operations require washing hands. See Annex A for general hand washing.
大多数洁净室操作都要求洗手。一般洗手方法见附录A。
If required, put on a pair of disposable cleanroom gloves before donning the cleanroom garment.
如需穿戴洁净服，应先佩戴一副一次性洁净室手套。
Select appropriately sized garment. 选择合适尺寸的服装。
Only the bottoms of cleanroom boots may contact the floor.
洁净室靴子仅底部可接触地面。
Use a full-length mirror to perform a final check that the garment fits appropriately, and all cleanroom garments are adjusted accordingly to limit skin, hair, and under clothing exposure to the cleanroom.
使用全身镜进行最终检查，确保洁净服合身，并对所有洁净服进行相应调整，以防止皮肤、毛发和内层衣物暴露在洁净室环境中。
If procedure requires, apply approved sanitization to the gloves.
如果规程有要求，应对手套进行经批准的消毒处理。
The individual is now ready to enter the cleanroom.
此人现在可以进入洁净室了。
Items concealed under a person’s cleanroom garment should not be taken out once gowning is complete. Those items should all remain under the garment until the de- gowning process is completed.
洁净服穿戴完成后，不应将藏匿于洁净服下的物品取出。这些物品应始终保持在洁净服内，直至完成脱衣流程。
order to remove garments; 脱衣顺序； assessment of garments (multiple use with reprocessing or reuse without processing); 洁净服评估（经处理后多次使用或未经处理重复使用）； specify storage of garment when reuse without processing; 明确未经处理重复使用时洁净服的储存要求； garment sharing and storage off shift. 洁净服的共用及非工作班次期间的储存。
NOTE Local requirements for items such as socks, underwear and personal protection equipment can exist.
袜子、内衣和个人防护装备等物品可能有当地要求。
Management may establish minimum change out requirements, but frequency of change outs is also dependent on individual personnel. Some people will naturally perspire more than others, or some cleanroom activities can dirty the cleanroom garments faster for particular personnel (e.g., foreign object debris generation, contact with the floor). Both situations require personnel awareness for change outs. All multiple use garments should be laundered per established specifications and removed from usage, when at the end of service life.
管理层可设定最低更换要求，但更换频率也取决于人员个体情况。有些人天生比其他人更容易出汗，或者某些洁净室活动可能会让特定人员的洁净服更快变脏（例如产生异物碎片、接触地面等）。这两种情况都需要人员具备更换意识。所有可重复使用的洁净服均应按既定规范进行清洗，且当达到使用期限时，需停止使用并淘汰。
Annex C (informative)
Training 培训
The training programme should ensure that all personnel who enter a cleanroom are educated appropriately based on their job requirements, the programme should consider training that is necessary for managers, manufacturing technicians, quality staff, researchers, engineers, maintenance and service technicians, contract employees and visitors. Periodic retraining is highly recommended for personnel who work routinely in a cleanroom to maintain their skills and to update them about operational changes.
培训计划应确保所有进入洁净室的人员根据其工作要求接受适当的教育，该计划应考虑管理人员、生产技术人员、质量人员、研究人员、工程师、维护和服务技术人员、合同工及访客所需的培训。强烈建议对常规在洁净室工作的人员进行定期再培训，以维持其技能并使其了解操作变更的最新情况。
Designing a training programme to develop understanding of and critical thinking for cleanroom activities will provide an educational foundation for personnel. An effective training programme is typically performed by qualified and experienced trainers and addresses key elements such as:
设计培训计划以培养人员对洁净室活动的理解和批判性思维，将为人员提供教育基础。有效的培训计划通常由具备资质和经验的培训师执行，并涵盖以下关键要素：
initial qualification and periodic requalification for personnel, based on expected job functions within the cleanroom; 基于人员在洁净室内预期的工作职能，对其进行初始资质认证和定期再认证； keeping records to track adherence to required trainings and qualifications; 保存记录以跟踪对所需培训和资质的遵守情况； procedures to assess training effectiveness and to improve training content and methods; 评估培训有效性以及改进培训内容和方法的程序； adherence to procedures. 遵守规程。
The content of training will vary by type of product and process; however, common training among personnel should include the basic principles of cleanroom science, gowning, cleaning, and monitoring. Training for specific cleanroom operations should be customized to ensure personnel understand differences between cleanroom requirements and production process requirements. Additional, specialized training should be provided, as necessary.
培训内容将因产品和工艺类型而异；然而，人员的通用培训应包括洁净室科学的基本原理、洁净服穿戴、清洁和监控。针对特定洁净室操作的培训应定制化，以确保人员理解洁净室要求与生产工艺要求之间的差异。必要时，还应提供额外的专业培训。
Periodic retraining should refresh personnel’s understanding about cleanroom technology, allow personnel to clarify issues they have encountered, and focus on updates for improvements and changes in operational standards.
定期再培训应更新人员对洁净室技术的理解，让人员澄清遇到的问题，并聚焦于操作标准的改进和变更内容更新。
The following items are suggested and should be maintained within a recordkeeping system:
建议将以下项目纳入记录保存系统并进行管理：
training requirements for each job role; 每个岗位的培训要求；
training activities performed and respective results by individual based on job or role; 基于岗位或职责，个人所执行的培训活动及相应结果；
training assignments for all personnel, including dates by which training should be completed; 所有人员的培训任务，包括培训应完成的日期；
in- house and external trainers and their qualifications;
内部和外部培训师及其资质；
scheduled, periodic re- training; 预定的定期再培训；
requirements for re- training if procedures or equipment are updated or modified;
当程序或设备更新或修改时的再培训要求；
an approved approach for maintaining and retrieving training records.
用于维护和检索培训记录的经批准方法。
The training programme should also consider the consequences for personnel and the organization, if they fail to meet training requirements.
培训计划还应考虑人员未满足培训要求时对其自身及组织的后果。
The training delivery methodology can include the following:
培训交付方法可包括以下内容：
theoretical (classroom) parts; 理论（课堂）部分；
demonstrations,videos; 演示；视频；
practice: virtual reality (VR) training can be considered; 实践：可考虑虚拟现实（VR）培训； examinations of theory and practice. 理论和实践的考核。
Emergency situations can arise and emergency response personnel, trained in all aspects of potential emergencies, can minimize the effects of mishaps that occur. All employees should be trained for an orderly evacuation. If an evacuation is necessary, provisions should be made for the orderly exit and orderly return to the cleanroom once the situation is cleared. An emergency procedure for supplying fresh cleanroom clothing should be implemented.
可能会出现紧急情况，而接受过潜在紧急情况各方面培训的应急响应人员可以将发生的事故影响降至最低。所有员工都应接受有序疏散的培训。如果有必要疏散，应做好相关安排，确保人员有序撤离，并在情况解除后有序返回洁净室。还应实施供应新鲜洁净室服装的应急程序。
Annex D (informative)
Cleaning 清洁
D.1 General 总则
This annex gives guidance on how to set up a cleaning programme, which is referenced in 7.5.
本附录为如何制定清洁计划提供指导，该内容在7.5中有提及。
D.2 Cleanroom surfaces 洁净室表面
The cleaning programme can address the following types of surfaces:
清洁计划可针对以下类型的表面：
floors, subfloors (underneath a raised floor) and mezzanines; 地板、底层地板（架空地板下方）及夹层； walls, doors, return grilles, windows and other vertical surfaces; 墙壁、门、回风格栅、窗户及其他垂直表面； ceilings, diffusers, lamp fixtures and other fixtures upstream or close to work areas; 天花板、扩散器、灯具及工作区域上游或附近的其他固定装置； stationary equipment; 固定设备； tools (upon entry or when kept inside of the cleanroom); 工具（进入洁净室时或存放在洁净室内部时）； tables, workstations, and other critical horizontal surfaces; 桌子、工作站及其他关键水平表面； cleanroom furniture, such as chairs and ladders; 洁净室家具，如椅子和梯子； cross-over benches, supply and cleanroom clothing supply cabinets, lockers and other compartmented surfaces; 跨接工作台、供应及洁净室服装供应柜、储物柜和其他分隔式表面； carts and trolleys; 手推车和搬运车； rubbish bins and containers; 垃圾桶和容器； cleanroom mats and sticky flooring. 洁净室地垫和粘性地板。
Surface areas not mentioned above can be addressed in a cleaning programme as necessary.
上述未提及的表面区域可根据需要纳入清洁计划中。
The required surface cleanliness level of all surfaces should be identified.
所有表面所需的表面清洁度等级均应予以确定。
D.3 Cleaning methods 清洁方法
In ISO 14644- 13, cleaning methods for both environmental surface and object surfaces are given. The cleaning efficiency of a cleaning method is determined by four complementary factors: mechanical forces, chemistry, time and temperature.
在ISO 14644-13中，给出了环境表面和物体表面的清洁方法。一种清洁方法的清洁效率由四个互补因素决定：机械力、化学作用、时间和温度。
One or more manual cleaning methods can be specified to ensure that the required level of surface cleanliness can be attained. Cleaning methods to be considered are:
可指定一种或多种手动清洁方法，以确保达到所需的表面清洁度等级。需考虑的清洁方法如下：
dry and wet vacuum cleaning: can be applied for precleaning; dry cleanroom vacuum cleaning can be used for locations that cannot be reached by mopping; wet vacuum cleaning can remove contamination that is suspended and dissolved in a non-solvent cleaning liquid and spills; 干式和湿式真空清洁：可用于预清洁；干式洁净室真空清洁可用于拖把无法触及的位置；湿式真空清洁可清除悬浮和溶解在非溶剂清洁液中的污染物以及溢出物。 dry mopping: can be applied for precleaning; chemical treated dry mops can cause chemical contamination; 干拖清洁：可用于预清洁；经化学处理的干拖把可能导致化学污染。 scrubbing: can be used for removal of stains or heavily soiled areas; scrubbing machines will generate contamination that needs to be removed by regular cleanroom cleaning; 擦洗：可用于去除污渍或重度污染区域；擦洗机会产生污染物，需通过洁净室常规清洁予以清除。 mopping: can be used for precision cleaning; a 2 or preferably 3 bucket system should be used in a specified sequence; a prepared mop should be assigned to a limited area; 拖地：可用于精密清洁；应按指定顺序使用两桶系统，最好是三桶系统；已准备好的拖把应分配至限定区域。 damp cleaning: can be used for precision cleaning especially when a high cleaning frequency (each shift) is applied; the area that may be cleaned by a pre-saturated cleanroom microfibre mop is limited and should be specified; 湿擦清洁：可用于精密清洁，尤其是在高清洁频率（每班）的情况下；预饱和洁净室微纤维拖把可清洁的区域有限，应予以指定。 wiping: can be used for manual precision cleaning of smaller work areas; dry or pre-saturated wipes can be used; alternatively, a wipe can be moistened with an alcohol solution by the user just before cleaning; 擦拭：可用于对较小工作区域进行手动精密清洁；可使用干式或预饱和擦拭布；或者，使用者可在清洁前刚刚用酒精溶液润湿擦拭布。 swabbing: can be used for manual precision cleaning of areas that cannot be reached with a wipe. 擦拭取样：可用于对擦拭布无法触及的区域进行手动精密清洁。
Other effective cleaning methods can be considered.
其他有效的清洁方法也可予以考虑。
Specific cleanroom applications require that certain surface treatments or finishes are applied to cleanroom surfaces, to provide characteristics that normally would not exist such as protective coatings and conductive coatings in electrostatic discharge protected areas. The use of surface treatments and finishes, after cleaning, should be avoided if possible. These treatments deteriorate with time and can compromise the cleanliness of the cleanroom. In addition, these treatments can contaminate the process or product if not used or maintained properly.
特定的洁净室应用要求对洁净室表面进行某些表面处理或涂层，以赋予其通常不具备的特性，例如在静电放电防护区域使用的防护涂层和导电涂层。清洁后应尽可能避免使用表面处理和涂层。这些处理会随时间推移而变质，可能影响洁净室的清洁度。此外，如果使用或维护不当，这些处理可能会污染工艺或产品。
D.4 Cleaning agents 清洁剂
A cleaning agent can be added to the cleaning liquid (for example filtered demineralised water) to assist easier release of surface contamination. The selected agent should be compatible with the materials to be cleaned and cleanliness levels with respect to chemicals of interest. There should be no residues.
可在清洁液（如经过滤的去离子水）中添加清洁剂，以帮助更轻松地去除表面污染物。所选清洁剂应与待清洁材料兼容，且在目标化学物质方面符合清洁度等级要求，同时不应残留任何物质。
The solution of cleaning agents and finishes should be as clean as required to meet the particle and chemical requirements of the surface.
清洁剂和涂饰剂的溶液应根据需要保持清洁，以满足表面的颗粒和化学要求。
The filtration of pre- packaged solutions should be considered. If ready- to- use is not used, written instructions should be in place to safely mix the solution to the correct concentration.
应考虑预包装溶液的过滤问题。如果不使用即用型溶液，则需制定书面说明，以确保安全地将溶液混合至正确浓度。
The following are typical types of cleaning solutions:
以下是典型的清洁溶液类型：
clean filtered, distilled, or deionized water or water for injections (wfi). Deionized water has many desirable properties, but it can corrode certain types of surfaces and may be ineffective in cleaning without the addition of a surfactant; 经过清洁过滤的蒸馏水、去离子水或注射用水（WFI）。去离子水具有许多理想特性，但它可能会腐蚀某些类型的表面，并且在不添加表面活性剂的情况下可能无法有效清洁。 solutions with surfactants or detergents. non-ionic surfactants are generally preferred for cleaning of cleanrooms as this group is the least reactive; 含有表面活性剂或洗涤剂的溶液。非离子表面活性剂通常更适合洁净室的清洁，因为这类表面活性剂的反应活性最低。 organic solvents can also be used for removing contamination on hard surfaces. All cleaning solutions should be approved as acceptable for the cleanroom and the product being produced. 有机溶剂也可用于去除硬质表面上的污染物。所有清洁溶液均应经批准，确保适用于洁净室及所生产的产品。
D.5 Consumables and equipment used in cleaning
清洁过程中使用的消耗品和设备
In ISO 14644- 14 and ISO 14644- 15, guidance is given on the cleanroom suitability of equipment. Typical cleaning equipment items are:
在ISO 14644-14和ISO 14644-15中，针对设备的洁净室适用性提供了指导。典型的清洁设备包括：
receptacles for rubbish and recycling; 垃圾和回收物容器 vacuum cleaners; 真空吸尘器 buckets or containers with wringers; 带绞拧装置的水桶或容器 floor scrubbers and single brush; 地板擦洗机和单毛刷 buffing and waxing machines; 抛光打蜡机； stepladders; 梯子； brooms, brushes; 扫帚、刷子； renewable tacky flooring; 可再生防滑地板； hand tools, boxes and maintenance equipment; 手动工具、箱子及维修设备； carts and trolleys. 手推车和小推车。
NOTE Ensure that the reservoirs of cleaning solution pump dispensers are cleaned periodically cleaned, as these can concentrate extractable residues over time and potentially contaminate surfaces.
注意：请确保定期清洁清洁溶液泵分配器的储液罐，因为随着时间的推移，这些储液罐可能会积聚可萃取残留物，并有可能污染表面。
In ISO14644-18, guidanceisgivenfortheselectionofcleanroomconsumable.
在ISO14644-18中，提供了关于洁净室消耗品选择的指南。
Typical cleaning consumablesare: 典型的清洁消耗品有：
wipes 擦拭布
swabs 拭子
mops 拖把
sticky mats 粘尘垫
clean containers and packaging. 清洁容器和包装。
D.6 Monitoring cleaning effectiveness 清洁效果监测
Appropriate contamination checks or cleanliness measurements should be carried out on a routine basis to ensure the cleanroom is maintained at specified levels. Appropriate cleanliness verification methods should be selected (see ISO 14644- 13:2017, Clause 12 and Annex D). Verifying cleaning results should follow the sequence:
应定期进行适当的污染检查或洁净度测量，以确保洁净室维持在规定的级别。应选择适当的洁净度验证方法（见ISO 14644-13:2017第12章和附录D）。清洁结果的验证应遵循以下顺序：
visual inspection to verify cleaning effectiveness (see ISO 14644-13:2017, D.2) 目视检查以验证清洁效果（见ISO 14644-13:2017，D.2） direct surface cleanliness measurements (see ISO 14644-13:2017, D.3) 直接表面洁净度测量（见ISO 14644-13:2017，D.3） indirect surface cleanliness measurement methods (see ISO 14644-13:2017, D.4). 间接表面洁净度测量方法（见ISO 14644-13:2017，D.4）。
If applicable, it is recommended that, when possible, limits be determined from actual measurements, using the test methods. Surface cleanliness measurement methods are described in ISO 14644- 9 and ISO 14644- 10.
如适用，建议在可能的情况下，使用测试方法通过实际测量来确定限值。表面洁净度测量方法在ISO 14644-9和ISO 14644-10中有描述。
If applicable, measurement of the deposition rate of particles or microorganisms can provide information on the expected surface contamination rate during operation.
如适用，颗粒或微生物沉积速率的测量可提供运行期间预期表面污染率的相关信息。
D.7 Cleaning programme 清洁方案
To support the cleaning programme described in 7.5, different zones and different kinds of cleanroom surfaces can be identified, and their individual surface cleanliness level limit determined.
为支持7.5中所述的清洁方案，可对不同区域和不同类型的洁净室表面进行识别，并确定其各自的表面洁净度级别限值。
Schedules need to be specified to ensure cleaning is performed frequently enough to maintain the required cleanliness of the surfaces. Testing and evaluation of the surface contamination will assist establishing schedules as well as investigation of the deposition rate of contaminants (see ISO 14644- 17).
需规定清洁时间表，以确保清洁频率足以维持表面所需的洁净度。表面污染的测试和评估将有助于制定清洁时间表，并调查污染物的沉积速率（见ISO 14644-17）。
The following steps can be followed when preparing a cleaning programme:
制定清洁方案时，可遵循以下步骤：
identify all surfaces and assign them to critical, general or other surfaces; 识别所有表面并将其划分为关键表面、一般表面或其他表面； determine an appropriate cleaning and surface treatment method for achieving the desired cleanliness level; 确定合适的清洁和表面处理方法，以达到所需的洁净度等级； prepare detailed written cleaning instructions 制定详细的书面清洁说明 prepare the cleaning schedules 制定清洁时间表 decide how to monitor the cleaning results and react to discrepancies 决定如何监控清洁结果并对偏差采取应对措施 train all personnel for the expected level of involvement in the cleaning programme 对所有人员进行培训，使其达到清洁方案所要求的参与水平 provide adequate storage facilities for the required cleaning materials 为所需的清洁材料提供充足的存储设施 organize all documents and schedules so that they can be reviewed and managed effectively; 整理所有文件和时间表，以便对其进行有效审核和管理； have a system in place for cleaning upon emergency cases. 建立一套适用于紧急情况的清洁系统。
To ensure, that the cleaning programme is effective, a verification of the methods upon implementation is recommended.
为确保清洁方案有效，建议在实施时对相关方法进行验证。
Cleaning operations should be performed on a regularly scheduled and frequent basis. Some cleaning operations are done in reaction to events that create contamination and are not subject to normal scheduling. The frequencies can be set as determined but should be adjusted to the needs of the cleanliness levels as based on a risk assessment and cleaning evaluation.
清洁操作应按定期且频繁的时间表执行。部分清洁操作是针对产生污染的事件而进行的，不受常规时间表限制。清洁频率可按既定标准设定，但应基于风险评估和清洁评估，根据洁净度级别的需求进行调整。
Consideration should be given for protecting critical surfaces, including products and tools, when cleaning occurs nearby.
当在附近进行清洁时，应考虑保护关键表面，包括产品和工具。