重磅，ISO 14644-5: 2025《洁净室及相关控制环境：操作》发布！Part II
Foreword 序言
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non- governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
国际标准化组织（ISO）是由各国标准化机构（ISO成员机构）组成的全球性联合会。制定国际标准的工作通常由ISO技术委员会完成。若某个技术委员会已就某一主题成立，对该主题感兴趣的每个成员机构都有权派代表参加该委员会。与ISO保持联络的政府间和非政府间国际组织也会参与相关工作。在所有电工技术标准化事务方面，ISO与国际电工委员会（IEC）开展密切合作。
The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
制定本文件及旨在对其进行进一步维护的程序在《ISO/IEC导则 第1部分》中有详细说明。尤其需要注意的是，不同类型的ISO文件所需要的批准标准各不相同。本文件是根据《ISO/IEC导则 第2部分》的编辑规则起草的（详见www.iso.org/directives）。
ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
ISO提醒注意，实施本文件可能涉及专利的使用。对于任何与此相关的已声明专利权的证据、有效性或适用性，ISO不持立场。截至本文件发布之日，ISO尚未收到实施本文件可能需要的专利通知。但需提醒实施者，这可能并非最新信息，最新信息可从www.iso.org/patents的专利数据库获取。ISO不负责识别任何或所有此类专利权。
Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.
本文件中使用的任何商品名称仅为方便用户提供信息，不构成背书。
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
如需了解标准的自愿性性质、与合格评定相关的ISO特定术语和表述的含义，以及ISO在《技术性贸易壁垒协定》（TBT）中遵守世界贸易组织（WTO）原则的信息，请访问www.iso.org/iso/foreword.html。
This document was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments, in collaboration with the European Committee for Standardisation (CEN) Technical Committee CEN/TC 243, Cleanroom technology, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
本文件由ISO/TC 209技术委员会“洁净室及相关受控环境”与欧洲标准化委员会（CEN）CEN/TC 243技术委员会“洁净室技术”根据ISO与CEN的技术合作协议（维也纳协议）合作编制。
This second edition cancels and replaces the first edition (ISO 14644- 5:2004), which has been technically revised.
本第二版取消并替代了经技术修订的第一版（ISO 14644-5:2004）。
The main changes are as follows: 主要变化如下：
new normative content for development of an impact assessment, development of an Operations Control Programme and the associated programmes that support cleanroom operation, and updated information concerning the movement of goods and materials into and out of the cleanrooms; 新增了用于制定影响评估、制定操作控制计划及支持洁净室运行的相关计划的规范性内容，还更新了关于货物和物料进出洁净室的信息； informative sections have been condensed so as to indicate information available in books and papers. 对说明性章节进行了精简，以指明可从书籍和论文中获取的信息。
A list of all parts in the ISO 14644 series can be found on the ISO website.
可在ISO网站上查阅ISO 14644系列的所有分册列表。
Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.
关于本文件的任何反馈或疑问，应提交给用户所在国家的标准化机构。这些机构的完整列表可在www.iso.org/members.html查询。
Introduction 引言
Cleanrooms and associated controlled environments provide for the control of contamination to air and surface cleanliness levels appropriate for accomplishing contamination- sensitive activities.
洁净室及相关受控环境可实现对污染的控制，使空气和表面洁净度达到适合开展污染敏感型活动的水平。
Consistent quality depends, in part, on cleanliness. Specified cleanliness levels for all contaminants addressed in the ISO 14644 series can be attained and maintained through a deliberate programme to establish and implement adequate design and operational procedures. Regulatory agencies that have authority over processes and products produced in the cleanroom can require additional procedures and measures.
稳定的质量在一定程度上取决于洁净度。通过制定并实施周全的计划，以确立和执行适当的设计与操作程序，可实现并维持ISO 14644系列中所涉及的所有污染物的特定洁净度等级。对在洁净室中生产的工艺和产品拥有监管权的机构，可能会要求额外的程序和措施。
Processes and products that benefit from the control of contamination include those in industries such as aerospace, automotive, assorted consumer products, defence, microelectronics, optics, nuclear, scientific research and life sciences (pharmaceuticals, biotechnology, medical devices, food, healthcare).
从污染控制中受益的工艺和产品涵盖以下行业领域：航空航天、汽车、各类消费品、国防、微电子、光学、核能、科学研究以及生命科学（包括制药、生物技术、医疗器械、食品、医疗保健等）。
This document specifies basic requirements for cleanroom operations. It is intended for those who design, construct, start up or operate a cleanroom. For guidance about consumables and equipment used in cleanrooms refer to the ISO 14644 series.
本文件规定了洁净室运行的基本要求，适用于洁净室的设计、建造、启动或运行人员。有关洁净室用消耗品和设备的指南，请参考ISO 14644系列标准。
Cleanrooms and associated controlled environments —
洁净室及相关受控环境
Part 5: Operations 操作
1 Scope 范围
This document specifies requirements for the establishment of an operations control programme (OCP) to ensure efficient cleanroom operation within specified cleanliness levels. The OCP includes management of personnel, entry and exit of personnel and materials, cleaning, maintenance and monitoring.
本文件规定了建立操作控制程序（OCP）的要求，以确保洁净室在规定的洁净度等级内高效运行。该操作控制程序包括人员管理、人员和物料的进出管理、清洁、维护和监测。
This document specifies operational requirements that relate to:
本文件规定了与以下方面相关的操作要求：
providing a system that specifies policies and operational procedures for maintaining cleanliness levels; 提供一个用于规定维持洁净度等级的政策和操作程序的体系。 training of personnel; 人员培训； transferring, installing and maintaining stationary equipment; 固定设备的转移、安装和维护； transferring material and portable equipment into and out of the cleanroom; 物料和便携式设备进出洁净室的转移； maintaining a personnel management programme that includes a gowning programme; 维持包含着装方案的人员管理计划； maintaining a cleaning programme that addresses special cleaning; 维持包含特殊清洁的清洁计划； maintaining a cleanroom maintenance programme; 维持洁净室维护计划； establishing an appropriate monitoring programme. 建立适当的监测计划。
This document gives additional information in annexes for:
personnel management; 人员管理；
gowning; 着装；
training; 培训
cleaning 清洁
This document does not specifically address biocontamination control. For details on this topic, see ISO 14698- 1 and ISO 14698- 2.
本文件未专门涉及生物污染控制。有关该主题的详细信息，请参见ISO 14698-1和ISO 14698-2。
This document does not apply to the following topics:
本文件不适用于以下主题：
aspects of health and safety management that have no direct bearing on contamination control; 与污染控制无直接关联的健康与安全管理方面； specific requirements for individual industries; 个别行业的特定要求； specific requirements for equipment and materials used or associated with processes and products; 用于工艺和产品或与工艺和产品相关的设备及材料的特定要求； design details of equipment; 设备的设计细节； cleaning agent compatibility with cleanroom materials. 清洁剂与洁净室材料的相容性。
2 Normative references 规范性引用文件
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
以下文件在本文件中被引用，其部分或全部内容构成本文件的要求。对于注明日期的引用，仅引用的版本适用。对于未注明日期的引用，适用所引用文件的最新版本（包括任何修订）。
ISO 14644- 1, Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
ISO 14644- 9, Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration
ISO 14644- 10, Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination
ISO 14644- 18, Cleanrooms and associated controlled environments - Part 18: Assessment of suitability of consumables
3 Terms and definitions 术语和定义
For the purposes of this document, the following terms and definitions apply.
就本文件而言，适用以下术语和定义。
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
国际标准化组织（ISO）和国际电工委员会（IEC）在以下地址维护了用于标准化工作的术语数据库：
ISO Online browsing platform: available at https://www.iso.org/obp
IEC Electropedia: available at https://www.electropedia.org/
3.1 cleaning efficiency 清洁效率
fraction of specific contaminants removed from a surface by a cleaning process
通过清洁工艺从表面去除的特定污染物的比例
Note 1 to entry: The fraction is determined by the accomplished surface cleanliness in respect to the initial surface cleanliness.
注释1：该比例通过相对于初始表面清洁度所达到的表面清洁度来确定。
[SOURCE:ISO 14644- 13:2017,3.3]
3.2 cleanliness 清洁度
condition not exceeding a specified level of contamination
不超过规定污染水平的状态
[SOURCE:ISO 14644- 15:2017,3.5]
3.3 cleanroom 洁净室
room within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room.
房间内空气中悬浮粒子的数量浓度得到控制和分级，并且其设计、建造和运行方式旨在控制房间内粒子的引入、产生和滞留。
Note 1 to entry: The class of airborne particle concentration is specified.
空气中悬浮粒子浓度的级别已被规定。
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations can also be specified and controlled.
空气当中其他清洁度属性的等级（例如化学物质、活菌或纳米级物质的浓度），以及表面清洁度（包括颗粒、纳米级物质、化学物质和活菌的浓度）也可进行规定和控制。
Note 3 to entry: Other relevant physical parameters can also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic.
其他相关物理参数也可根据需要进行控制，例如温度、湿度、压力、振动和静电。
[SOURCE:ISO 14644- 1:2015,3.1.1]
3.4 clean zone
defined space which is constructed and operated in a manner to control the introduction, generation and retention of contaminants inside the space below a maximum concentration of airborne particles based on its designation.
根据其指定要求构建和运行的限定空间，该空间通过控制污染物的引入、产生和滞留，使空间内空气中悬浮粒子浓度不超过最大限定值。
Note 1 to entry: The class of airborne particle concentration is specified.
空气中悬浮粒子浓度的级别已被规定。
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations can also be specified and controlled.
空气和表面的其他清洁度属性水平也可进行规定和控制，例如空气中化学物质、活菌或纳米级物质的浓度，以及表面的颗粒、纳米级物质、化学物质和活菌浓度。
Note 3 to entry: A clean zone(s) can be a defined space within a cleanroom or can be achieved by a separative device. Such a device can be located inside or outside a cleanroom.
洁净区可以是洁净室内的限定空间，也可以通过分隔装置实现。此类装置可设置在洁净室内或室外。
Note 4 to entry: Other relevant physical parameters can also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic.
其他相关物理参数也可根据需要进行控制，例如温度、湿度、压力、振动和静电。
[SOURCE: ISO 14644- 1:2015, 3.1.2]
3.5 consumable 消耗品
item selected for a prescribed, limited use and subsequent disposal, if applicable, within cleanrooms and controlled environments.
在洁净室和受控环境中为特定的有限用途而选择的物品，适用时使用后需进行处理。
Note 1 to entry: Consumables can be garments, gloves, (see 3.11) and wipes, swabs, paper.
消耗品可以是洁净服、手套（见3.11）以及擦拭布、拭子、纸张等。
Note 2 to entry: Items for use and disposal, if applicable within cleanrooms and controlled environments.
在洁净室和受控环境中使用的物品，适用时使用后需进行处理。
[SOURCE: ISO 14644- 18:2023, 3.9]
3.6 contamination 污染
unwanted matter in an undesirable location 在不合意位置出现的有害物质
[SOURCE: ISO 14644- 13:2017, 3.4]
3.7 installation 安装
cleanroom or one or more clean zones, together with all associated structures, air- treatment systems, services and utilities.
洁净室或一个及以上洁净区，连同所有相关结构、空气处理系统、服务设施及公用设施。
[SOURCE: ISO 14644- 1:2015, 3.1.3]
3.8 operational 运行
agreed condition where the cleanroom or clean zone is functioning in the specified manner, with equipment operating and with the specified number of personnel present.
洁净室或洁净区按规定方式运行、设备处于运行状态且配备规定数量人员时的约定状态
[SOURCE: ISO 14644- 1:2015, 3.3.3]
3.9 particle 粒子
minute piece of matter with defined physical boundaries
具有明确物理边界的微小物质
[SOURCE: ISO 14644- 1:2015, 3.2.1]
3.10 personnel 人员
persons entering the cleanroom for any purpose
出于任何目的进入洁净室的人员
3.11 personal consumable 个人消耗品
consumable (3.5) that is worn by a person （3.5）人员穿戴的消耗品
[SOURCE:ISO14644- 18:2023,3.15]
3.12 service life 使用寿命
length of time or number of cycles a consumable is suitable for use
消耗品适用的时间长度或使用次数
Note 1 to entry: In this document, items are considered as consumable (3.5).
Note 2 to entry: Service life is dependent on appropriate use.
[SOURCE: ISO 14644- 18:2023, 3.16, modified - added Note 1 to entry.]
3.13 shutdown 停机
action of turning off or taking out of operation 关闭或停止运行的动作
Note 1 to entry: It can be applied to equipment within the installation.
3.14 verification 验证
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
通过提供客观证据，确认特定要求已得到满足的过程
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.
验证所需的客观证据可以是检查结果，或其他形式的判定结果，例如进行替代计算或审核文件。
Note 2 to entry: The activities carried out for verification are sometimes called a qualification process.
Note 3 to entry: The word “verified” is used to designate the corresponding status.
4 Abbreviations 缩写
OCP Operations control programme 运行控制程序
5 General 总则
A cleanroom or associated controlled environment is designed to protect processes or products from contamination. The operations within the cleanroom impact air cleanliness, deposition rates and surface cleanliness. The specifications of the product and process determine the required cleanliness levels and operational requirements.
洁净室或相关受控环境旨在保护工艺或产品免受污染。洁净室内的操作会影响空气洁净度、沉积速率和表面洁净度。产品和工艺的规格决定了所需的洁净度等级和操作要求。
An impact assessment is intended to identify factors that can prevent the cleanroom from attaining or maintaining the required cleanliness concerning contaminants of interest (particles, macro- particles, microorganisms, chemicals and/or nanoparticles). The cleanroom shall have adequate ancillary areas, such as utilities, equipment storage and equipment preparation to support its operations. An impact assessment, as discussed in Clause 6, is the basis for the operations control programme, which is discussed in 7.2.
影响评估旨在识别可能阻碍洁净室达到或维持针对相关污染物（颗粒、大颗粒、微生物、化学物质和/或纳米颗粒）所需洁净度的因素。洁净室应配备足够的辅助区域，如公用设施区、设备存储区和设备准备区，以支持其运行。正如第6章所讨论的，影响评估是第7.2节所探讨的运行控制程序的基础。
A cleanroom or clean zone that operates successfully within specified limits requires a systematic approach, starting with design and continuing throughout construction, commissioning, selecting equipment, and operating the process. Cleaning of surfaces, equipment, and transferred items shall be accomplished in a manner that will not impact operations. The systematic approach includes operational aspects, such as the control and limiting of emissions and the effects of potential cross- contamination, electrostatic discharge, maintenance and personnel.
一个在规定限值内成功运行的洁净室或洁净区需要采用系统化方法，从设计开始，贯穿施工、调试、设备选型以及工艺运行的全过程。表面、设备和转移物品的清洁方式应确保不影响操作。该系统化方法涵盖操作层面的多个方面，例如对污染物排放的控制与限制、潜在交叉污染的影响、静电放电、维护保养以及人员管理等。
Trained individuals are critical for cleanroom operation. Personnel executing operations in cleanrooms shall be managed as discussed in 7.4.
经过培训的人员对洁净室运行至关重要。在洁净室执行操作的人员应按照7.4节所述进行管理。
Operations shall be documented in procedures and monitored, as discussed in Clause 8.
操作应按程序文件记录并进行监控，如第8章所述。
An overview of cleanroom operational aspects is shown in Figure 1. The desired limits for air cleanliness, contamination deposition rate, and product and process specifications with the intended operations control programme are the input for the establishment of contamination control. Potentially applicable cleanroom standards that can be used to fulfil these specifications and limits are shown in Figure 1; corresponding paragraphs from Clauses 7 and 8 of this document are shown in parentheses.
图1展示了洁净室运行方面的概述。空气洁净度、污染沉积速率的预期限值，以及产品和工艺规格与预期运行控制程序，是建立污染控制的输入。图1显示了可用于满足这些规格和限值的潜在适用洁净室标准；本文件第7章和第8章的相应段落以括号形式列出。
Figure 1 — Overview of operational aspects of a cleanroom
图1 — 洁净室运行方面概述
6 Impact assessment 影响评估
The goal of the impact assessment is to understand factors that may affect the cleanroom from operating within specified limits. An impact assessment shall be performed for the start of the routine cleanroom operation and shall be revisited or revised as part of planning major modifications, including an exchange of stationary equipment.
影响评估的目标是了解可能影响洁净室在规定限值内运行的因素。应对洁净室常规运行启动时进行影响评估，并且在规划重大改造（包括固定设备更换）时，应将其作为规划的一部分重新审视或修订。
The impact assessment is based on design data or as- built data for the cleanroom installation and the specified cleanroom environment with its operations. It shall include the impact on products or processes to aide in determining the operations in the environment.
影响评估基于洁净室设施的设计数据或竣工数据，以及规定的洁净室环境及其运行情况。评估应包括对产品或工艺的影响，以协助确定该环境中的操作。
The following aspects shall be assessed for their impact on achieving and maintaining specified cleanliness levels:
以下方面应对其在实现和维持规定洁净度等级方面的影响进行评估：
operations programme, including an assessment that necessary procedures are available and adequate; 运行程序，包括评估必要的程序是否存在且充分； cleaning programme execution and control of surface cleanliness; 清洁程序的执行及表面洁净度的控制 gowning programme; 更衣程序 selection of personal and non-personal consumables (ISO 14644-18, if applicable); 人员及非人员消耗品的选择（如适用，参考ISO 14644-18）； maintenance programme for the installation; 设施的维护程序； maintenance programme for the stationary equipment including considerations for repair during operation; 固定设备的维护程序，包括运行期间维修的考量； transfer of material, mobile equipment and tools in and out and within the cleanroom or clean zone; 物料、移动设备和工具进出洁净室或洁净区以及在其内部的转移； transfer of stationary equipment in and out of the cleanroom;
固定设备进出洁净室的转移；
programme for monitoring of cleanliness parameters.
洁净度参数的监控程序。
Special consideration shall be given for the impact of personnel. At a minimum the following aspects shall be assessed:
人员的影响应给予特殊考虑。至少应评估以下方面：
entry and exit procedures; 进出程序；
maximum cleanroom occupancy; 洁净室最大容纳人数；
flow and activity of personnel within the cleanroom; personal attire, hygiene and behaviour (including behaviour prior to entering the cleanroom);
洁净室内人员的流动和活动；个人着装、卫生及行为（包括进入洁净室前的行为）；
use of personal electronic devices; 个人电子设备的使用；
health status (e.g., chronic or acute medical conditions, including shedding significantly more contamination than anticipated);
健康状况（例如，慢性或急性疾病，包括产生比预期更多的污染物）；
programmes for achieving and maintaining necessary skills;
实现和维持必要技能的计划；
safety (including emergency procedures); 安全性（包括应急程序）；
policies and procedures for visitors. 访客的政策和程序。
The impact assessment shall address routine operation, reduced operation, shutdown and restart of the installation.
影响评估应涵盖设施的常规运行、降负荷运行、停机及重启情况。
Literature searches can provide methodologies for impact assessments that are applicable to specific industries.
文献检索能够为适用于特定行业的影响评估提供方法论。
7 Operations Control 运行控制
7.1 General 总体
Successful operations in cleanrooms benefit from thorough design, construction and start up, as outlined in ISO 14644- 4, which includes considerations for products and related processes. However, cleanroom operations that were not anticipated during design or construction phase shall also be assessed. OCP shall be established and implemented to support maintaining the cleanroom within specified limits for operation, reduced operation, maintenance and shutdown.
洁净室的成功运行得益于全面的设计、建造和启动，如ISO 14644-4中所概述的，其中包括对产品及相关工艺的考量。然而，对于设计或建造阶段未预见的洁净室运行情况，也应进行评估。应制定并实施运行控制程序（OCP），以支持在常规运行、降负荷运行、维护和停机期间将洁净室维持在规定的限值内。
7.2 Operations control programme 运行控制程序
7.2.1 General 总体
The OCP is part of the overall contamination control strategy. Cleanrooms are designed to mitigate contamination, such as particles, chemicals or microorganisms, from the product and process. Operational elements can impact the required air and surface cleanliness levels. Adherence to the OCP will ensure that operational requirements can be met. Subclause 7.2.3 addresses additional control requirements for established cleanrooms that were designed with an undefined purpose or that have been modified. The OCP includes sustainability (ISO 14644- 16) and efficient use of consumables (ISO 14644- 18).
运行控制程序（OCP）是整体污染控制策略的组成部分。洁净室的设计旨在降低产品和工艺受到的污染（如颗粒、化学物质或微生物）。运行要素可能影响所需的空气和表面洁净度等级。遵守运行控制程序可确保满足运行要求。7.2.3 小节针对设计用途不明确或已改造的现有洁净室，提出了额外控制要求。运行控制程序涵盖可持续性（ISO 14644-16）和消耗品的高效使用（ISO 14644-18）。
The total number of personnel allowed in a cleanroom is related to the cleanroom design and the needs of the process operations.
洁净室内允许的人员总数与洁净室设计和工艺操作需求相关。
7.2.2 Elements of the OCP 运行控制程序的要素
Management shall establish, implement and maintain an OCP. It shall address how the cleanroom shall be operated within specified limits while manufacturing or handling products. The OCP shall address start- up, reduced operation, and shutdown.
管理层应建立、实施并维护运行控制程序（OCP）。该程序应规定在制造或处理产品时，洁净室如何在规定限值内运行。运行控制程序还应涵盖启动、降负荷运行和停机等情况。
At a minimum, the OCP shall address and include the following:
至少，运行控制程序应涉及并包括以下内容：
documented impact assessment; 有记录的影响评估； standard operating procedures or work instructions for all aspects of cleanroom setup, operation, reduced operation, and shutdown; 洁净室设置、运行、降负荷运行及停机所有方面的标准操作程序或工作指导书； documents showing the flow of products and raw materials, equipment, personnel and waste; 显示产品和原材料、设备、人员及废弃物流向的文件； personnel management programme (requirements, gowning, training); 人员管理程序（要求、洁净服穿戴、培训）； cleaning programme; 清洁程序； maintenance programme (cleanroom installation, equipment); 维护程序（洁净室设施、设备）； monitoring programme. 监测程序。
7.2.3 Additional considerations for the operations control programme
运行控制程序的额外注意事项
The following points can have an impact on the cleanroom operation and shall be assessed for any changes to the design:
以下要点可能对洁净室运行产生影响，应对设计的任何变更进行评估：
utilities (compressed gasses, water systems, chemicals); 公用设施（压缩气体、水系统、化学品）； vibration; 振动； electromagnetic fields (e.g., interference, compatibility); 电磁场（如干扰、兼容性）； electrostatic properties of materials; 材料的静电特性； lighting (e.g., natural, artificial, and non-visible wavelength); 照明（如自然光源、人工光源及不可见波长光源）； chemical emissions; 化学排放； thermal load from equipment; 设备产生的热负荷； changed airflow patterns due to equipment placement; 因设备放置而改变的气流模式； modified standard operating procedures, work instructions and calibrations; 修改后的标准操作程序、工作指导书和校准程序； storage of materials. 材料的储存。
7.3 Materials Flow 物料流动
7.3.1 General 总则
A documented system to control the transfer of materials, components, equipment and tools into and out of the cleanroom shall be established.
应建立文件化系统，以控制物料、组件、设备和工具进出洁净室的转移。
Only materials, equipment and cleaning agents that are evaluated and found acceptable for use in the cleanroom shall be permitted in the cleanroom. A formal written procedure shall be in place for handling the response to an unexpected entry of unapproved items in the cleanroom.
仅经评估且被认定可在洁净室使用的物料、设备和清洁剂方可进入洁净室。应制定正式书面程序，以处理洁净室中未经批准物品意外进入的情况。
Documented information shall be retained for the evaluation and acceptability of all materials used in the cleanroom.
洁净室所用的所有材料，其评估和可接受性的文件化信息应予以保留。
7.3.2 Incoming materials and components 来料和组件
Protective packaging for transport or storage should be removed outside the cleanroom and the airlock and the materials cleaned to an agreed particulate level compatible with the room’s ISO specification. Cleanroom packaging, which is in contact with or intended to protect the materials and which is specifically approved for entry into the cleanroom, may be removed inside the cleanroom before use. ISO 14644- 9 and ISO 14644- 10 define acceptable cleanliness levels for particles and chemicals, as applicable.
运输或储存用的防护包装应在洁净室和气闸室外拆除，并将物料清洁至与房间ISO规范兼容的约定颗粒水平。与物料接触或旨在保护物料且专门批准进入洁净室的洁净室包装，可在使用前于洁净室内拆除。ISO 14644-9和ISO 14644-10规定了适用的颗粒和化学品可接受清洁度水平。
NOTE Cardboard is not regarded as suitable material for cleanrooms, unless specially proven (ISO 14644- 18).
注：除非经专门验证（ISO 14644-18），否则纸板不被视为适用于洁净室的材料。
Additional cleaning of incoming materials can occur in a controlled environment, airlocks, and pass- throughs to meet increasing cleanliness. Cleaning shall be performed and can include outer bag removal, wiping, UV light, or gases, as appropriate and can involve a system of suitable clean containers, such as a cleanroom- approved conveyor or cart. Carts and containers and the materials transported in them should be assessed for suitability as stated in ISO 14644- 13, ISO 14644- 14, and ISO 14644- 15, as applicable.
来料的额外清洁可在受控环境、气闸室和传递窗中进行，以满足更高的洁净度要求。清洁工作应按要求执行，可包括拆除外袋、擦拭、紫外线照射或气体清洁等适当方式，并可使用合适的洁净容器系统，如经洁净室认可的传送带或推车。应根据适用的ISO 14644-13、ISO 14644-14和ISO 14644-15标准，评估推车、容器及其运输的物料的适用性。
7.3.3 Finished goods 成品
Finished product should be protected, e.g., inside an approved container or packaging system, prior to leaving the cleanroom through a designated and controlled exit. Any cart or containers shall be cleaned appropriately before return to the cleanroom.
成品在通过指定且受控的出口离开洁净室前，应采取保护措施（例如置于经批准的容器或包装系统内）。任何推车或容器在返回洁净室前均应进行适当清洁。
7.3.4 Waste removal 废弃物清除
Solid material waste should be placed in specific containers for safe removal. Wipes and used consumables may be separated and may be identified for recycling. Liquid waste should be marked and sealed for controlled disposal outside the room. Gaseous waste and exhaust air should be properly disposed of outside of the cleanroom. Consider whether local requirements or contamination control measures require the use of a dedicated exit airlock for wastes.
固体废弃物应置于特定容器中以便安全清除。擦拭布和用过的消耗品可进行分类，并可标记用于回收。液体废弃物应做好标识并密封，以便在洁净室外受控处置。气态废弃物和排风应在洁净室外妥善处理。需考虑当地要求或污染控制措施是否要求为废弃物使用专用的出口气闸室。
7.3.5 Transfer of maintenance tools and test equipment
维护工具和测试设备的转移
Maintenance tools and test equipment should be thoroughly cleaned and packaged, if applicable, before admission to the cleanroom through an airlock.
维护工具和测试设备在通过气闸室进入洁净室前，应根据需要进行彻底清洁并包装（若适用）。
It is recommended that frequently used tools and equipment, such as ladders, tool boxes and cleanroom cleaning equipment, remain in the cleanroom.
建议将常用工具和设备（如梯子、工具箱及洁净室清洁设备）留存于洁净室内。
7.3.6 Transfer and installation of large or stationary equipment 大型或固定设备的转移与安装
Where process equipment cannot be installed or removed without interruption to the cleanroom, a documented process that includes a description and approval of the work shall be followed.
当工艺设备的安装或拆卸必然会对洁净室造成干扰时，应遵循文件化程序，其中需包括对作业内容的描述及审批流程。
7.4 Personnel management programme 人员管理方案
7.4.1 Requirements and restrictions 要求与限制
Personnel are a major source of contamination to products and the cleanroom environment. Potential contamination due to activities and presence of personnel, particularly with respect to specified personnel flow, hand washing and personal hygiene, are part of the personnel management programme.
人员是产品和洁净室环境的主要污染源。人员活动及存在可能导致的污染（尤其是在规定的人员流向、洗手和个人卫生方面）属于人员管理方案的一部分。
Physical or timely separation between ingoing and outgoing cleanroom personnel is recommended to reduce the impact of cross- contamination on the cleanroom, product or process. Consider whether one- way flow of personnel is required in the cleanroom.
建议对进出洁净室的人员进行物理隔离或时间隔离，以降低交叉污染对洁净室、产品或工艺的影响。需考虑洁净室是否要求人员单向流动。
All cleanroom personnel shall comply with requirements for cleanroom entry, operational procedures, and basic behaviours and conduct requirements that include:
所有洁净室人员均应遵守洁净室准入要求、操作程序以及基本行为规范，包括：
donning all required cleanroom garments properly prior to cleanroom entry according to the cleanroom garment programme (7.4.2).
根据洁净室着装方案（7.4.2），所有人员在进入洁净室前均需正确穿戴全部规定的洁净室服装。
wearing their cleanroom garments and other appropriate items according to procedures and exit the cleanroom if the integrity of the garments is damaged or otherwise compromised;
按照规程穿戴洁净室服装及其他合适物品，若服装完整性受损或出现其他损坏情况，应退出洁净室。
adhering to all specified personal hygiene requirements; not entering the cleanroom if displaying visible illness, or experiencing symptoms that are not under control (e.g., excessive sneezing or coughing);
遵守所有规定的个人卫生要求；若出现明显患病症状或存在未受控的症状（如频繁打喷嚏或咳嗽），则不得进入洁净室。
entering and exiting the cleanroom only through designated personnel airlocks, if applicable;
如适用，仅通过指定的人员气闸室进出洁净室。
completing all training and participate in continual education or training courses on a schedule;
完成所有培训并按计划参加继续教育或培训课程。
adhering to all applicable procedures, e.g., entry and exit, transfer, gowning, operation control and production processes;
遵守所有适用程序，例如进出、转移、着装、操作控制及生产流程。
reporting cleanroom problems, including potential contamination issues, to management promptly.
及时向管理层报告洁净室问题，包括潜在的污染问题。
As part of the impact assessment (Clause 6), a review shall be conducted to determine requirements for personal items and personal hygiene that can be sources of particle, microbial, or chemical contamination. Examples of items to consider for exclusion from the cleanroom can be found in Annex A, Personnel Management.
作为影响评估（第6章）的一部分，应开展审查以确定对可能成为颗粒、微生物或化学污染来源的个人物品和个人卫生的要求。关于考虑禁止带入洁净室的物品示例，可参见附件A“人员管理”。
Practices that keep the impact of behaviour on cleanroom cleanliness under control shall be specified. At a minimum, the criticality assessed in the impact assessment should guide how the following activities are conducted:
应明确规定将人员行为对洁净室清洁度影响纳入控制的相关规范。至少，影响评估中所评估的关键程度应指导以下活动的开展方式：
use of airlocks and personnel transfer; behaviour for planned or unplanned shutdowns/evacuations; use of doors; organization and management of workstations according to specified requirements; conduct in a manner that minimizes the possibility of contamination being generated, stirred up, or transferred or deposited on or into product; cleaning practices.
气闸室和人员转移的使用；计划内或计划外停机/疏散时的行为规范；门的使用；根据规定要求对工作站进行组织和管理；以尽量减少污染产生、扬起、转移或沉积在产品上或进入产品中的方式行事；清洁规范。
7.4.2 Gowning programme 着装方案
7.4.2.1 General 总则
As part of cleanroom operation, a gowning procedure shall be established and implemented before personnel are allowed to enter the cleanroom. The purpose of the gowning programme is to ensure that cleanliness levels with respect to particles, chemicals and microorganisms can be maintained when personnel are in the cleanroom. Personal consumables, e.g., garments, gloves, face masks, shall be selected and used appropriately in accordance with ISO 14644- 18 and the user specification.
作为洁净室运行的一部分，应制定并实施人员进入洁净室前的着装程序。着装方案的目的是确保人员在洁净室内时，能够维持颗粒、化学物质和微生物相关的洁净度等级。个人消耗品（如洁净服、手套、口罩等）应根据ISO 14644-18及用户技术规范合理选择和使用。
The gowning programme shall be considered in the impact assessment.
着装方案应在影响评估中予以考虑。
7.4.2.2 Requirements for a gowning programme 着装方案的要求
Facilities and procedures shall be in place for proper handling of cleanroom personal consumables.
应具备适当处理洁净室个人消耗品的设施和程序。
At a minimum the following items shall be addressed in the gowning programme:
着装方案至少应包含以下内容：
fabric selection to meet the barrier, strength, and lint properties as required to maintain the desired cleanliness level for the specified activity, including repair and laundry requirements; 面料选择需满足阻隔性、强度和起毛性能要求，以维持特定活动所需的洁净度等级，包括修补和洗衣要求。 personal consumables selection process and its result and conclusion, including documentation; 个人消耗品的选择流程及其结果与结论，包括相关文件记录。 gowning procedures; 着装程序
NOTE Gowning procedures can be adapted for various activities performed in the cleanroom, e.g., for personnel who are present for operations, maintenance, or supervision.
注：着装程序可根据洁净室内开展的各类活动进行调整，例如针对执行操作、维护或监督等工作的人员。
justification for multiple uses of personal consumable, including documentation; 个人消耗品多次使用的理由，包括相关文件记录。 justification of and documentation for service life of garments; 洁净服使用寿命的理由说明及相关文件记录。 storage of the personal consumables; 个人消耗品的储存 removal of used personal consumables; 用过的个人消耗品的移除 sterility, if required. 无菌性（如需）。
Additional information and details are provided in Annex B.
附加信息和详细内容见附件B。
7.4.3 Training 培训
Management shall establish and implement a programme to train persons who enter a cleanroom. Training requirements shall be based on the role and area which the person will access.
管理层应制定并实施针对进入洁净室人员的培训计划。培训要求应基于人员的职责角色及所进入的区域来确定。
The ability of personnel to incorporate all elements of cleanroom training into practice is essential to the continuous effective operation of the cleanroom.
人员将洁净室培训的所有要素融入实践的能力，对洁净室的持续有效运行至关重要。
Appropriate training shall be completed prior to cleanroom entry. A training programme should consider the following topics:
进入洁净室前应完成适当的培训。培训计划应考虑以下主题：
cleanroom operation procedures; 洁净室操作程序； personal hygiene procedures; 个人卫生程序； entry and exit of personnel; 人员进出； gowning requirements and procedures; 着装要求和程序； necessary procedures, and work instructions, including cleanroom procedures to maintain cleanliness levels; 必要的程序和工作指导，包括维持洁净度等级的洁净室程序； transfer of materials and equipment; this can include items that are approved for use in cleanrooms, and those not approved for use; 物料和设备的转移；这可包括批准在洁净室使用的物品和未批准使用的物品； cleaning procedures, where applicable; 清洁程序（如适用）； behaviour in cleanrooms to minimize generation of contamination that can be transferred or deposited on or into the product; 洁净室内的行为规范，以最大限度减少可能转移或沉积在产品上的污染物产生； monitoring levels, such as alert and alarm levels and required responses; 监测水平，如警戒和报警限及所需响应； individual behaviour and responsibilities for cleanroom access and operations; 人员进入洁净室和操作的个人行为及职责； procedures for problem reporting, and encouraging cleanroom personnel to report potential issues; 问题报告程序，及鼓励洁净室人员报告潜在问题； requirements for individual personnel certification for cleanroom access, and how often recertification is required; 人员进入洁净室的个人认证要求及再认证频率； personnel monitoring programme; 人员监测计划 safety and emergency response. 安全与应急响应。
Management should periodically assess whether training is adequate and shall ensure, that personnel have completed the required training. Periodic retraining is recommended and should be scheduled, as necessary.
管理层应定期评估培训是否充分，并应确保人员已完成所需培训。建议定期进行再培训，并应根据需要安排时间。
Basic training documentation should include course contents, personnel identification information, training and learning objective check dates. Documented evidence for successful completion of training programme shall be available. A system can be used to document completion of required training.
基础培训文件应包括课程内容、人员身份信息、培训及学习目标考核日期。应具备培训计划成功完成的书面证据。可使用一个系统来记录所需培训的完成情况。
Additional information and details on training can be found in Annex C.
有关培训的更多信息和详细内容可在附件C中查阅。
7.5 Cleaning programme 清洁计划
7.5.1 General 总则
Cleanroom cleaning can be divided into room surfaces, critical surfaces and equipment cleaning. The required cleanliness level of surfaces and the means to achieve them shall be specified.
洁净室清洁可分为房间表面、关键表面和设备清洁。应规定表面所需的洁净度等级及其实现方法。
An assessment shall be executed to determine the required cleanliness levels for all cleanroom surfaces (e.g., cleanroom installation, equipment, tools). This assessment shall be used as the basis for the cleaning programme.
应进行评估以确定所有洁净室表面（如洁净室设施、设备、工具）所需的洁净度等级。该评估应用作清洁计划的依据。
The cleaning programme shall include the following topics:
清洁计划应包括以下主题：
contaminants of concern, such as particles, chemicals, microorganisms, as applicable based on product or process requirements; 需关注的污染物，例如颗粒、化学物质、微生物，具体根据产品或工艺要求适用； required cleanliness levels; 所需的洁净度等级； areas or items to be cleaned; 需清洁的区域或物品； initial contamination level; 初始污染水平； cleaning appropriateness, efficiency and potential residues; 清洁的适用性、效率及潜在残留物； cleaning frequency; 清洁频率； cleaning methodology; 清洁方法； disinfection methodology, if applicable; 消毒方法（如适用）； required procedures and documentation. 所需的程序和文件。
The cleaning frequency should be established to maintain the required surface cleanliness levels. The time between cleaning cycles will be based on the cleaning efficiency and contributors to the surface contamination rate, e.g., the number of personnel, their garments, and their work methods, and process emissions.
应确定清洁频率以维持所需的表面洁净度等级。清洁周期之间的时间将基于清洁效率和表面污染率的影响因素，例如人员数量、人员着装及其工作方法，以及工艺排放情况。
In case of control of microorganisms, a disinfection programme should be included in the cleaning programme (see references [9], [10], [11]).
如涉及微生物控制，清洁计划中应包含消毒方案（参见参考文献[9]、[10]、[11]）。
Additional information and details on cleanroom cleaning can be found in Annex D.
有关洁净室清洁的更多信息和详细内容可在附件D中查阅。
7.5.2 Requirements for the cleaning programme 清洁计划的要求
In order to identify the requirements of a cleaning programme, consider the following items:
为了明确清洁计划的要求，请考虑以下事项：
cleaning instructions, cleaning sequences; NOTE Flow diagrams can be helpful. 清洁说明、清洁顺序； 注：流程图可能会有所帮助。 activities necessary, routinely and in case of emergency; 日常必要活动及紧急情况下的必要活动； frequency; 频率 personnel and their roles; 人员及其职责； identification of all surfaces to be subjected to cleaning and their required cleanliness level; 确定所有需清洁的表面及其所需的洁净度等级； compatibility of cleaning solutions with surfaces that are to be cleaned; 清洁溶液与待清洁表面的相容性； preparation of materials and supplies; 物料和用品的准备； preparation of solutions, specific concentrations, and expiry;
溶液的配制、具体浓度及有效期；
i) gathering necessary equipment, tools and consumables from storage;
从储存处收集必要的设备、工具和消耗品；
j) transfer of cleaning items into the cleanroom; 将清洁物品转移至洁净室；
k) proper techniques, speed, movement and sequence; 适当的技术、速度、移动方式和顺序；
l) disposal of solutions, used consumables, mops, wipes;
溶液、用过的消耗品、拖把、擦拭布的处理；
m) preparation of cleaning equipment for re-use;
清洁设备的重复使用准备工作；
n) verification steps, where necessary; 必要时的验证步骤；
o) documentation requirements; 文件记录要求；
p) monitoring (refer to clause 8). 监控（参见第8条）。
Cleaning methods can be tested by measuring the surface cleanliness levels before and after cleaning. Refer to ISO 14644- 9, ISO 14644- 10 and ISO 14644- 13, as applicable.
清洁方法可通过测量清洁前后的表面洁净度水平来进行测试。适用时，参考ISO 14644-9、ISO 14644-10和ISO 14644-13。
Cleaning practices that risk contaminating products or processes should be assessed to determine proper controls, such as removing or covering products before cleaning begins.
应评估可能污染产品或工艺的清洁操作，以确定适当的控制措施，例如在清洁开始前移走产品或对其进行覆盖。
7.5.3 Special cleaning 特殊清洁
Special cleaning can be required due to unexpected contamination of cleanroom surfaces, operator error, extended shutdowns, equipment problems, corrective maintenance, cleanroom malfunctions, power failures, and natural disasters. The objective of a special cleaning is to remove the impact of such an event.
由于洁净室表面意外污染、操作人员失误、长时间停机、设备问题、纠正性维护、洁净室故障、电源故障和自然灾害等情况，可能需要进行特殊清洁。特殊清洁的目标是消除此类事件的影响。
A plan for special cleaning should be in place. In this plan, consider the following:
应制定特殊清洁计划。在该计划中，需考虑以下内容：
product impact; 产品影响； special cleaning methods and where they can be applied; 特殊清洁方法及其可应用的场景； verification of the surface cleanliness level; 表面洁净度水平的验证 transition to routine cleaning after special cleaning. 特殊清洁后转为常规清洁。
It is recommended to assess the cleanroom installation for proper function at normal capacity after special cleaning.
建议在特殊清洁后对洁净室设施进行评估，以确认其在正常产能下的功能是否正常。
7.6 Maintenance programme 维护计划
Management shall establish and document a maintenance programme. Documentation shall be maintained for the cleanroom installation itself and the equipment used for production. Routine preventive and, where feasible, predictive maintenance should be scheduled so as not to interfere or conflict with the cleanroom operations or to create unnecessary contamination impact. The programme shall address unplanned repair and modifications. These operations shall be conducted using adequate procedures to mitigate impact on cleanliness levels.
管理层应制定维护计划并形成文件记录。应对洁净室设施本身及生产用设备的维护文件进行保存。应安排常规预防性维护，在可行情况下安排预测性维护，以避免对洁净室运行造成干扰或冲突，或产生不必要的污染影响。该计划应涵盖非计划性维修和改造。进行这些操作时，应采用适当的程序以减轻对洁净度水平的影响。
When performing scheduled maintenance or unscheduled repairs, special partitioning or intensified monitoring may be required. It is strongly recommended for maintenance or repairs to be done when the cleanroom is not in use. Prior to resuming the use of the cleanroom after conducting maintenance or repairs, an evaluation shall be done to determine whether cleaning or monitoring is required.
执行定期维护或非计划维修时，可能需要进行特殊隔断或强化监控。强烈建议在洁净室未使用时进行维护或维修。在维护或维修后恢复使用洁净室前，应进行评估以确定是否需要清洁或监控。
Special circumstance can dictate the need to use temporary air handling systems to maintain differential air pressure during maintenance. Welding, soldering, and grinding that generate high particulate levels should be contained or exhausted.
特殊情况下，可能需要在维护期间使用临时空气处理系统来维持压差。对于会产生高颗粒水平的焊接、钎焊和研磨操作，应进行隔离或排风处理。
Major modifications are generally performed when the cleanroom is idle from normal operations. If this is not possible, protocols shall be established to control contamination (ISO 14644- 4 as appropriate).
洁净室通常在正常运行空闲时进行重大改造。如果无法做到这一点，则应制定协议来控制污染（适当时可参考ISO 14644-4）。
NOTE 1 For cleaning and cleaning requirements for maintenance tools, refer to 7.5. 关于维修工具的清洁及其清洁要求，请参考7.5。
NOTE 2 For entry and exit of maintenance tools and equipment, refer to 7.3.5.
维修工具和设备的进出要求，请参考7.3.5。
NOTE 3 Applicable local environmental and safety requirements can exist for handling tools and components exposed to hazardous waste.
处理接触危险废物的工具和部件时，可能需要遵守当地适用的环境和安全要求。
Special attention should be given to the replacement of filters. Filter replacement may require the air supply to be reduced or ceased, which can affect the pressurisation. These temporary changes shall be assessed for cleanroom, product and process impact.
过滤器的更换应特别注意。更换过滤器可能需要减少或停止空气供应，这会影响洁净室的压力。对于这些临时性变化，应评估其对洁净室、产品及工艺的影响。
Testing of the terminal filters after initial installation or replacement can be performed in accordance with ISO 14644- 3.
终端过滤器在初次安装或更换后的测试可按照ISO 14644-3执行。
Whenever possible, equipment should be removed from the cleanroom for major repairs. If this is not possible, protocols shall be established to ensure that a potential contamination generated by this repair does not impact the cleanroom’s specified cleanliness levels.
只要有可能，设备应从洁净室移出进行大修。若无法做到这一点，则应制定协议，以确保该维修可能产生的潜在污染不会影响洁净室的规定洁净度等级。
Isolation of the equipment may be required to mitigate risk of contamination to the cleanroom.
可能需要对设备进行隔离，以降低对洁净室的污染风险。