标准编号:	GB/T 25915.1-2021
中文名称:	洁净室及相关受控环境 第1部分：按粒子浓度划分空气洁净度等级
英文名称:	Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness by particle concentration
中标分类:	C70    工业防尘防毒技术
行业分类:	GB    国家标准
发布机构:	国家市场监督管理总局 国家标准化管理委员会
发布日期:	2021-08-20
实施日期:	2022-3-1
标准状态:	valid
替代旧标准:	GB/T 25915.1-2010 洁净室及相关受控环境　第1部分：空气洁净度等级
翻译语言:	英文
文件格式:	PDF
中文字符数:	37000 字
翻译价格(元):	2590.0
交付时间:	付款后 1 个工作日

Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration 1 Scope This document specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in GB/T 25915.7. Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0.1 µm to 5 µm are considered for classification purposes. Concentrations of ultrafine particles (particles smaller than 0.1 µm) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of macroparticles (particles larger than 5 µm) at designated sampling locations. An M descriptor may be used to quantify populations of the macroparticles. This document cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 25915.2-2021 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015, IDT) GB/T 25915.7 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments) (GB/T 25915.7-2020, ISO 14644-7:2004, IDT) GB/T 29024.4-2017 Determination of particle size distribution - Single particle light interaction methods - Part 4: Light scattering airborne particle counter for clean spaces (ISO 21501-4:2007, IDT)   3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 General 3.1.1 cleanroom 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 Note 1: The class of airborne particle concentration is specified. Note 2: 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 might also be specified and controlled. Note 3: Other relevant physical parameters might also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic. 3.1.2 clean zone defined space within which the number concentration of airborne particles is controlled and classified, and which is constructed and operated in a manner to control the introduction, generation and retention of contaminants inside the space Note 1: The class of airborne particle concentration is specified. Note 2: 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 might also be specified and controlled. Note 3: A clean zone(s) can be a defined space within a cleanroom or might be achieved by a separative device. Such a device can be located inside or outside a cleanroom. Note 4: Other relevant physical parameters might also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic. 3.1.3 installation cleanroom or one or more clean zones, together with all associated structures, air-treatment systems, services and utilities 3.1.4 classification method of assessing level of cleanliness against a specification for a cleanroom or clean zone Note: Levels shall be expressed in terms of an ISO Class, which represents maximum allowable concentrations of particles in a unit volume of air. 3.2 Airborne particles 3.2.1 particle minute piece of matter with defined physical boundaries 3.2.2 particle size diameter of a sphere that produces a response, by a given particle-sizing instrument that is equivalent to the response produced by the particle being measured Note: For discrete-particle light-scattering instruments, the equivalent optical diameter is used. 3.2.3 particle concentration number of individual particles per unit volume of air 3.2.4 particle size distribution cumulative distribution of particle concentration as a function of particle size 3.2.5 macroparticle particle with an equivalent diameter greater than 5 µm 3.2.6 M descriptor designation for measured or specified concentration of macroparticles per cubic metre of air, expressed in terms of the equivalent diameter that is characteristic of the measurement method used Note: The M descriptor can be regarded as an upper limit for the averages at sampling locations. M descriptors cannot be used to define ISO Classes, but the M descriptor may be quoted independently or in conjunction with ISO Classes. 3.2.7 unidirectional airflow controlled airflow through the entire cross-section of a cleanroom or a clean zone with a steady velocity and airstreams that are considered to be parallel 3.2.8 non-unidirectional airflow air distribution where the supply air entering the cleanroom or clean zone mixes with the internal air by means of induction   3.3 Occupancy states 3.3.1 as-built condition where the cleanroom or clean zone is complete with all services connected and functioning but with no equipment, furniture, materials or personnel present 3.3.2 at-rest condition where the cleanroom or clean zone is complete with equipment installed and operating in a manner agreed upon, but with no personnel present 3.3.3 operational 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 3.4 Testing instrumentation 3.4.1 resolution smallest change in a quantity being measured that causes a perceptible change in the corresponding indication Note: Resolution can depend on, for example, noise (internal or external) or friction. It may also depend on the value of a quantity being measured. [Source: ISO/IEC Guide 99:2007, 4.14] 3.4.2 maximum permissible measurement error extreme value of measurement error, with respect to a known reference quantity value, permitted by specifications or regulations for a given measurement, measuring instrument, or measuring system Note 1: Usually, the term “maximum permissible errors” or “limits of error” is used where there are two extreme values. Note 2: The term “tolerance” shall not be used to designate “maximum permissible error”. [Source: ISO/IEC Guide 99:2007, 4.26] 3.5 Instrument specifications 3.5.1 light scattering (discrete) airborne particle counter; LSAPC instrument capable of counting and sizing single airborne particles and reporting size data in terms of equivalent optical diameter Note: The specifications for the LSAPC are given in GB/T 29024.4-2017. 3.5.2 discrete-macroparticle counter instrument capable of counting and sizing single airborne macroparticles Note: See Table F.1 for specifications. 3.5.3 time-of-flight particle sizing apparatus discrete-particle counting and sizing apparatus that defines the aerodynamic diameter of particles by measuring the time for a particle to accommodate to a change in air velocity Note 1: This is usually done by measuring the particle transit time optically after a fluid stream velocity change. Note 2: See Table F.2 for specifications.

Forward i Introduction iv 1 Scope 2 Normative references 3 Terms and definitions 4 Classification 5 Demonstration of compliance Annex A (Normative) Reference method for classification of air cleanliness by particle concentration Annex B (Informative) Examples of classification calculations Annex C (Informative) Counting and sizing of airborne macroparticles Annex D (Informative) Sequential sampling procedure Annex E (informative) Specification of intermediate decimal cleanliness classes and particle size thresholds Annex F (Informative) Test instruments Bibliography

洁净室及相关受控环境 第1部分： 按粒子浓度划分空气洁净度等级 1 范围 本文件规定了按空气中悬浮粒子浓度划分洁净室、洁净区、GB/T 25915.7所述的隔离装置中的空气洁净度等级。 本文件适用于粒径挡下限为0.1μm～5μm的颗粒物累积计数分布及其粒子浓度的监测。 超细粒子(＜0.1μm)的浓度将在纳米尺寸粒子空气洁净度标准中规定。在指定采样点，规定使用光散射(离散式)空气悬浮粒子计数器(LSAPC)判定大粒子(＞5μm)的粒子浓度，用M描述符对其量化。 本文件不适用于表征空气悬浮粒子的物理性、化学性、放射性、生物活性或其他特性。 2 规范性引用文件 下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文件，仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本(包括所有的修改单)适用于本文件。 GB/T 25915.2—2021 洁净室及相关受控环境 第2部分：洁净室空气粒子浓度的监测(ISO 14644-2：2015，IDT) GB/T 25915.7 洁净室及相关受控环境 第7部分：隔离装置(净化空气台、手套箱、隔离器和微环境)(GB/T 25915.7—2020，ISO 14644-7：2004，IDT) GB/T 29024.4—2017 粒度分析 单颗粒的光学测量方法 第4部分：洁净间光散射尘埃粒子计数器(ISO 21501-4：2007，IDT) 3 术语和定义 下列术语和定义适用于本文件。 3.1 基本 3.1.1 洁净室 cleanroom 空气悬浮粒子浓度受控并分级的房间，其设计、建造到运行均使进入、产生、滞留于房间的粒子受控。 注1：规定了按空气悬浮粒子浓度划分的级别。 注2：也可对影响洁净度等级的其他因素，如空气中化学物、微生物或纳米尺度粒子浓度等，以及影响表面洁净度等级的其他因素，如粒子、纳米粒子、化学物或微生物浓度等，作出规定并进行控制。 注3：温度、湿度、压力、振动和静电等相关的物理参数，也可按要求受控。 3.1.2 洁净区 clean zone 空气悬浮粒子计数浓度受控并分级的限定空间。其建造和运行使进入、产生和滞留于空间的粒子受控。 注1：空气悬浮粒子浓度的级别已确定。 注2：也可对影响洁净度等级的其他因素，如空气中化学物、微生物或纳米尺度粒子浓度等，以及影响表面洁净度等级的其他因素，如粒子、纳米粒子、化学物或微生物浓度等，作出规定并进行控制。 注3：洁净区可以是限定于洁净室内的空间，也可用隔离装置实现。隔离装置既可设在洁净室内也可在洁净室外。 注4：温度、湿度、压力、振动和静电等相关的物理参数，也可按要求受控。 3.1.3 设施 installation 连同所有相关构筑物、空气处理系统、供给和公用设施的洁净室或一个、多个洁净区。 3.1.4 分级 classification 按技术要求评定洁净室或洁净区洁净度水平的方法。 注：洁净度水平应以ISO等级浓度来描述，它代表单位容积空气内最大允许粒子浓度。 3.2 空气悬浮粒子 3.2.1 粒子 particle 具有规定物理边界的微小物质。 3.2.2 粒径 particle size 给定粒径测定仪测得的、与被测粒子响应量相当的球体直径。 注：光散射离散粒子计数仪给出的是光学等效直径。 3.2.3 粒子浓度 particle concentration 单位体积空气中粒子的个数。 3.2.4 粒径分布 particle size distribution 以累积分布表示的粒子浓度与粒径的函数关系。 3.2.5 大粒子 macroparticle 当量直径大于5μm的粒子。 3.2.6 M描述符 M descriptor 实测或规定的每立方米空气中大粒子浓度，其中的当量粒径与测量方法有关。 注：M描述符可视作采样点平均值的上限。不能用M描述符表示ISO洁净度等级，但M描述符可以单独引用或与ISO洁净度等级一起引用。 3.2.7 单向流 unidirectional airflow 通过洁净室或洁净区整个断面，风速稳定且平行的受控气流。 3.2.8 非单向流 non-unidirectional airflow 洁净室或洁净区的送风以诱导方式与室内空气混合的气流分布。 3.3 占用状态 3.3.1 空态 as-built 洁净室或洁净区所有服务设施就位并运行，但无设备、家具、材料和人员的状态。 3.3.2 静态 at-rest 洁净室或洁净区建成且设备就位，按议定的方式运行，但无人员在场的状态。 3.3.3 动态 operational 洁净室或洁净区设施按议定方式运行，且有规定数量的人员按议定方式工作的状态。 3.4 检测仪器 3.4.1 分辨率 resolution 可被测量的最小变量，即在相应显示中产生的、可辨认的变化。 注：噪声(内外部)或摩擦等因素可决定分辨率，被测的量值也可决定分辨率。 [来源：ISO/IEC Guide 99：2007，4.14] 3.4.2 最大允许测量误差 maximum permissible measurement error 对一项具体测量、或对测量仪或测量系统，相对于已知参照量值，技术条件或规范所允许的测量误差极值。 注1：在有两个极限值时，通常用术语“最大允许误差”或“误差限值”予以区分。 注2：“公差”不可用于表示“最大允许误差”。 [来源：ISO/IEC Guide 99：2007，4.26] 3.5 仪器规格 3.5.1 光散射(离散式)空气悬浮粒子计数器 light scattering (discrete) airborne particle counter；LSAPC 依据粒子的光学等效直径，对空气中单个粒子进行计数和测径的仪器。 注：GB/T 29024.4—2017给出了LSAPC的规格。 3.5.2 离散大粒子计数器 discrete-macroparticle counter 能够对空气中单个大粒子计数和测径的仪器。 注：其技术规格见附录F中表F.1。 3.5.3 飞行时间测径仪 time-of-flight particle sizing apparatus 以粒子适应风速变化的时间来测定其空气动力学直径的离散粒子计数、测径装置。 注1：通常借助光学方法测量流体速度变化后粒子的移动时间。 注2：其技术规格见表F.2。 4 分级 4.1 占用状态 应规定在“空态”“静态”和“动态”的某种或某几种占用状态下(见3.3)，对洁净室或洁净区按空气中粒子浓度进行分级。 4.2 粒径 当按粒子浓度划分空气洁净度等级时，范围为0.1μm～5μm的一个或几个粒径挡阈值(低值)。 4.3 ISO等级数 按粒子浓度划分的空气洁净度应标识为ISO N级。每个关注粒径的最大允许浓度见表1。 表1中不同粒径阈值的粒子浓度数目仅作为分级标准，并不反映空气中真实的粒径和数量分布。附录B中列举了几个分级计算实例。 表1 按粒子浓度划分的空气洁净度ISO级别 ISO等级数N 大于或等于关注粒径的粒子最大允许浓度a 个/m3 0.1μm 0.2μm 0.3μm 0.5μm 1μm 5μm a 本表中的所有浓度都是累积的，例如ISO 5级，0.3μm所对应的10200个粒子包括所有粒径大于或等于该粒径的粒子。 b 这些浓度需大采样量才能用于分级。可以使用序贯采样程序，见附录D。 c 表格这一区域因粒子浓度太高，浓度限值不适用。 d 受采样和统计方法的制约，在粒子浓度低时不适用于分级。 e 粒径大于1μm的低浓度粒子在采样系统可能有损耗，此粒径不适合分级之用。 f ISO 5级中此粒径可采用大粒子M描述符，但至少要结合另一个粒径一起使用(见C.7)。 g 该级别只适用于动态。 4.4 表示方法 洁净室或洁净区内悬浮粒子浓度的表示方法应包括： a)以“ISO N级”表示的ISO等级数； b)分级时的占用状态； c)关注粒径。 如果关注粒径不止一个，较大粒径(D2)应至少是下个较小粒径(D1)的1.5倍，即D2≥1.5×D1。示例见表2。 表2 关注粒径示例表 ISO等级数 占用状态 关注粒径 D1 D2 ISO 4级 静态 0.2μm 0.5μm 4.5 非整数洁净度等级和粒径阈值 当需要非整数等级，或整数和非整数等级需要表1中未列出的粒径挡时，见附录E。 5 符合性的证明 5.1 原则 完成规定的检测程序，并提供检测条件和结果的相关文件，以此认证是否符合用户规定的空气洁净度(ISO等级数)要求。 静态和动态的分级通常依据风险评估情况每年进行。 对洁净室、洁净区和隔离装置的监测，应按照GB/T 25915.2—2021。 注：设施配备了连续或频繁监测粒子浓度和其他性能参数的仪器时，若监测结果保持在规定的监测限值内，分级检测时间间隔可以延长。 5.2 检测 附录A中给出了符合性检测的基准方法，也可以指定其他至少具备同等准确性的方法和(或)仪器。如无规定或议定的替代方法，应采用基准方法。 应采用校准有效期内的仪器进行符合性认证检测。 5.3 悬浮粒子浓度计算 按附录A完成检测后，每个采样点单次采样量的粒子浓度(以每立方米的粒子数目表示)不应超过表1中相应粒径的浓度限值或表E.1中相应粒径的非整数等级的浓度限值。如果在采样点进行了多次采样，浓度应取平均值并且平均浓度不得超过表1或表E.1给出的浓度限值。非表列粒径应由公式(E.1)计算得出。 为确定ISO等级，所有关注粒径粒子浓度应采用相同方法检测。 5.4 检测报告 各洁净室或洁净区的检测结果均应记录在案，以综合报告形式提交，并说明是否符合规定的按粒子浓度划分的空气洁净度等级。 检测报告应包括下述内容： a)检测机构的名称、地址和检测完成的日期； b)本文件编号，如GB/T 25915.1—2021； c)清楚地标明被测洁净室或洁净区的实际位置(必要时包括毗邻的参照区)及所有采样点的坐标(宜附图)； d)规定的洁净室或洁净区表示法，其中包括ISO等级数、相关的占用状态和关注粒径； e)检测方法的详细说明，包括与检测有关的特殊条件或对检测方法的偏离情况，及检测仪器的型号标识和当前的校准证书； f)检测结果，含全部采样点的粒子浓度数据； g)如果大粒子的浓度已参照附录C的说明作了量化，相关的信息也应包含在检测报告中。