標(biāo)準(zhǔn)編號:	GB/T 25915.1-2021
中文名稱:	潔凈室及相關(guān)受控環(huán)境 第1部分：按粒子濃度劃分空氣潔凈度等級
英文名稱:	Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness by particle concentration
中標(biāo)分類:	C70    工業(yè)防塵防毒技術(shù)
行業(yè)分類:	GB    國家標(biāo)準(zhǔn)
發(fā)布機構(gòu):	國家市場監(jiān)督管理總局 國家標(biāo)準(zhǔn)化管理委員會
發(fā)布日期:	2021-08-20
實施日期:	2022-3-1
標(biāo)準(zhǔn)狀態(tài):	valid
替代舊標(biāo)準(zhǔn):	GB/T 25915.1-2010 潔凈室及相關(guān)受控環(huán)境　第1部分：空氣潔凈度等級
翻譯語言:	英文
文件格式:	PDF
中文字符數(shù):	37000 字
翻譯價格(元):	2590.0
交付時間:	付款后 1 個工作日

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 “l(fā)imits 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

潔凈室及相關(guān)受控環(huán)境 第1部分： 按粒子濃度劃分空氣潔凈度等級 1 范圍 本文件規(guī)定了按空氣中懸浮粒子濃度劃分潔凈室、潔凈區(qū)、GB/T 25915.7所述的隔離裝置中的空氣潔凈度等級。 本文件適用于粒徑擋下限為0.1μm～5μm的顆粒物累積計數(shù)分布及其粒子濃度的監(jiān)測。 超細(xì)粒子(＜0.1μm)的濃度將在納米尺寸粒子空氣潔凈度標(biāo)準(zhǔn)中規(guī)定。在指定采樣點，規(guī)定使用光散射(離散式)空氣懸浮粒子計數(shù)器(LSAPC)判定大粒子(＞5μm)的粒子濃度，用M描述符對其量化。 本文件不適用于表征空氣懸浮粒子的物理性、化學(xué)性、放射性、生物活性或其他特性。 2 規(guī)范性引用文件 下列文件中的內(nèi)容通過文中的規(guī)范性引用而構(gòu)成本文件必不可少的條款。其中，注日期的引用文件，僅該日期對應(yīng)的版本適用于本文件；不注日期的引用文件，其最新版本(包括所有的修改單)適用于本文件。 GB/T 25915.2—2021 潔凈室及相關(guān)受控環(huán)境 第2部分：潔凈室空氣粒子濃度的監(jiān)測(ISO 14644-2：2015，IDT) GB/T 25915.7 潔凈室及相關(guān)受控環(huán)境 第7部分：隔離裝置(凈化空氣臺、手套箱、隔離器和微環(huán)境)(GB/T 25915.7—2020，ISO 14644-7：2004，IDT) GB/T 29024.4—2017 粒度分析 單顆粒的光學(xué)測量方法 第4部分：潔凈間光散射塵埃粒子計數(shù)器(ISO 21501-4：2007，IDT) 3 術(shù)語和定義 下列術(shù)語和定義適用于本文件。 3.1 基本 3.1.1 潔凈室 cleanroom 空氣懸浮粒子濃度受控并分級的房間，其設(shè)計、建造到運行均使進入、產(chǎn)生、滯留于房間的粒子受控。 注1：規(guī)定了按空氣懸浮粒子濃度劃分的級別。 注2：也可對影響潔凈度等級的其他因素，如空氣中化學(xué)物、微生物或納米尺度粒子濃度等，以及影響表面潔凈度等級的其他因素，如粒子、納米粒子、化學(xué)物或微生物濃度等，作出規(guī)定并進行控制。 注3：溫度、濕度、壓力、振動和靜電等相關(guān)的物理參數(shù)，也可按要求受控。 3.1.2 潔凈區(qū) clean zone 空氣懸浮粒子計數(shù)濃度受控并分級的限定空間。其建造和運行使進入、產(chǎn)生和滯留于空間的粒子受控。 注1：空氣懸浮粒子濃度的級別已確定。 注2：也可對影響潔凈度等級的其他因素，如空氣中化學(xué)物、微生物或納米尺度粒子濃度等，以及影響表面潔凈度等級的其他因素，如粒子、納米粒子、化學(xué)物或微生物濃度等，作出規(guī)定并進行控制。 注3：潔凈區(qū)可以是限定于潔凈室內(nèi)的空間，也可用隔離裝置實現(xiàn)。隔離裝置既可設(shè)在潔凈室內(nèi)也可在潔凈室外。 注4：溫度、濕度、壓力、振動和靜電等相關(guān)的物理參數(shù)，也可按要求受控。 3.1.3 設(shè)施 installation 連同所有相關(guān)構(gòu)筑物、空氣處理系統(tǒng)、供給和公用設(shè)施的潔凈室或一個、多個潔凈區(qū)。 3.1.4 分級 classification 按技術(shù)要求評定潔凈室或潔凈區(qū)潔凈度水平的方法。 注：潔凈度水平應(yīng)以ISO等級濃度來描述，它代表單位容積空氣內(nèi)最大允許粒子濃度。 3.2 空氣懸浮粒子 3.2.1 粒子 particle 具有規(guī)定物理邊界的微小物質(zhì)。 3.2.2 粒徑 particle size 給定粒徑測定儀測得的、與被測粒子響應(yīng)量相當(dāng)?shù)那蝮w直徑。 注：光散射離散粒子計數(shù)儀給出的是光學(xué)等效直徑。 3.2.3 粒子濃度 particle concentration 單位體積空氣中粒子的個數(shù)。 3.2.4 粒徑分布 particle size distribution 以累積分布表示的粒子濃度與粒徑的函數(shù)關(guān)系。 3.2.5 大粒子 macroparticle 當(dāng)量直徑大于5μm的粒子。 3.2.6 M描述符 M descriptor 實測或規(guī)定的每立方米空氣中大粒子濃度，其中的當(dāng)量粒徑與測量方法有關(guān)。 注：M描述符可視作采樣點平均值的上限。不能用M描述符表示ISO潔凈度等級，但M描述符可以單獨引用或與ISO潔凈度等級一起引用。 3.2.7 單向流 unidirectional airflow 通過潔凈室或潔凈區(qū)整個斷面，風(fēng)速穩(wěn)定且平行的受控氣流。 3.2.8 非單向流 non-unidirectional airflow 潔凈室或潔凈區(qū)的送風(fēng)以誘導(dǎo)方式與室內(nèi)空氣混合的氣流分布。 3.3 占用狀態(tài) 3.3.1 空態(tài) as-built 潔凈室或潔凈區(qū)所有服務(wù)設(shè)施就位并運行，但無設(shè)備、家具、材料和人員的狀態(tài)。 3.3.2 靜態(tài) at-rest 潔凈室或潔凈區(qū)建成且設(shè)備就位，按議定的方式運行，但無人員在場的狀態(tài)。 3.3.3 動態(tài) operational 潔凈室或潔凈區(qū)設(shè)施按議定方式運行，且有規(guī)定數(shù)量的人員按議定方式工作的狀態(tài)。 3.4 檢測儀器 3.4.1 分辨率 resolution 可被測量的最小變量，即在相應(yīng)顯示中產(chǎn)生的、可辨認(rèn)的變化。 注：噪聲(內(nèi)外部)或摩擦等因素可決定分辨率，被測的量值也可決定分辨率。 [來源：ISO/IEC Guide 99：2007，4.14] 3.4.2 最大允許測量誤差 maximum permissible measurement error 對一項具體測量、或?qū)y量儀或測量系統(tǒng)，相對于已知參照量值，技術(shù)條件或規(guī)范所允許的測量誤差極值。 注1：在有兩個極限值時，通常用術(shù)語“最大允許誤差”或“誤差限值”予以區(qū)分。 注2：“公差”不可用于表示“最大允許誤差”。 [來源：ISO/IEC Guide 99：2007，4.26] 3.5 儀器規(guī)格 3.5.1 光散射(離散式)空氣懸浮粒子計數(shù)器 light scattering (discrete) airborne particle counter；LSAPC 依據(jù)粒子的光學(xué)等效直徑，對空氣中單個粒子進行計數(shù)和測徑的儀器。 注：GB/T 29024.4—2017給出了LSAPC的規(guī)格。 3.5.2 離散大粒子計數(shù)器 discrete-macroparticle counter 能夠?qū)諝庵袉蝹€大粒子計數(shù)和測徑的儀器。 注：其技術(shù)規(guī)格見附錄F中表F.1。 3.5.3 飛行時間測徑儀 time-of-flight particle sizing apparatus 以粒子適應(yīng)風(fēng)速變化的時間來測定其空氣動力學(xué)直徑的離散粒子計數(shù)、測徑裝置。 注1：通常借助光學(xué)方法測量流體速度變化后粒子的移動時間。 注2：其技術(shù)規(guī)格見表F.2。 4 分級 4.1 占用狀態(tài) 應(yīng)規(guī)定在“空態(tài)”“靜態(tài)”和“動態(tài)”的某種或某幾種占用狀態(tài)下(見3.3)，對潔凈室或潔凈區(qū)按空氣中粒子濃度進行分級。 4.2 粒徑 當(dāng)按粒子濃度劃分空氣潔凈度等級時，范圍為0.1μm～5μm的一個或幾個粒徑擋閾值(低值)。 4.3 ISO等級數(shù) 按粒子濃度劃分的空氣潔凈度應(yīng)標(biāo)識為ISO N級。每個關(guān)注粒徑的最大允許濃度見表1。 表1中不同粒徑閾值的粒子濃度數(shù)目僅作為分級標(biāo)準(zhǔn)，并不反映空氣中真實的粒徑和數(shù)量分布。附錄B中列舉了幾個分級計算實例。 表1 按粒子濃度劃分的空氣潔凈度ISO級別 ISO等級數(shù)N 大于或等于關(guān)注粒徑的粒子最大允許濃度a 個/m3 0.1μm 0.2μm 0.3μm 0.5μm 1μm 5μm a 本表中的所有濃度都是累積的，例如ISO 5級，0.3μm所對應(yīng)的10200個粒子包括所有粒徑大于或等于該粒徑的粒子。 b 這些濃度需大采樣量才能用于分級。可以使用序貫采樣程序，見附錄D。 c 表格這一區(qū)域因粒子濃度太高，濃度限值不適用。 d 受采樣和統(tǒng)計方法的制約，在粒子濃度低時不適用于分級。 e 粒徑大于1μm的低濃度粒子在采樣系統(tǒng)可能有損耗，此粒徑不適合分級之用。 f ISO 5級中此粒徑可采用大粒子M描述符，但至少要結(jié)合另一個粒徑一起使用(見C.7)。 g 該級別只適用于動態(tài)。 4.4 表示方法 潔凈室或潔凈區(qū)內(nèi)懸浮粒子濃度的表示方法應(yīng)包括： a)以“ISO N級”表示的ISO等級數(shù)； b)分級時的占用狀態(tài)； c)關(guān)注粒徑。 如果關(guān)注粒徑不止一個，較大粒徑(D2)應(yīng)至少是下個較小粒徑(D1)的1.5倍，即D2≥1.5×D1。示例見表2。 表2 關(guān)注粒徑示例表 ISO等級數(shù) 占用狀態(tài) 關(guān)注粒徑 D1 D2 ISO 4級 靜態(tài) 0.2μm 0.5μm 4.5 非整數(shù)潔凈度等級和粒徑閾值 當(dāng)需要非整數(shù)等級，或整數(shù)和非整數(shù)等級需要表1中未列出的粒徑擋時，見附錄E。 5 符合性的證明 5.1 原則 完成規(guī)定的檢測程序，并提供檢測條件和結(jié)果的相關(guān)文件，以此認(rèn)證是否符合用戶規(guī)定的空氣潔凈度(ISO等級數(shù))要求。 靜態(tài)和動態(tài)的分級通常依據(jù)風(fēng)險評估情況每年進行。 對潔凈室、潔凈區(qū)和隔離裝置的監(jiān)測，應(yīng)按照GB/T 25915.2—2021。 注：設(shè)施配備了連續(xù)或頻繁監(jiān)測粒子濃度和其他性能參數(shù)的儀器時，若監(jiān)測結(jié)果保持在規(guī)定的監(jiān)測限值內(nèi)，分級檢測時間間隔可以延長。 5.2 檢測 附錄A中給出了符合性檢測的基準(zhǔn)方法，也可以指定其他至少具備同等準(zhǔn)確性的方法和(或)儀器。如無規(guī)定或議定的替代方法，應(yīng)采用基準(zhǔn)方法。 應(yīng)采用校準(zhǔn)有效期內(nèi)的儀器進行符合性認(rèn)證檢測。 5.3 懸浮粒子濃度計算 按附錄A完成檢測后，每個采樣點單次采樣量的粒子濃度(以每立方米的粒子數(shù)目表示)不應(yīng)超過表1中相應(yīng)粒徑的濃度限值或表E.1中相應(yīng)粒徑的非整數(shù)等級的濃度限值。如果在采樣點進行了多次采樣，濃度應(yīng)取平均值并且平均濃度不得超過表1或表E.1給出的濃度限值。非表列粒徑應(yīng)由公式(E.1)計算得出。 為確定ISO等級，所有關(guān)注粒徑粒子濃度應(yīng)采用相同方法檢測。 5.4 檢測報告 各潔凈室或潔凈區(qū)的檢測結(jié)果均應(yīng)記錄在案，以綜合報告形式提交，并說明是否符合規(guī)定的按粒子濃度劃分的空氣潔凈度等級。 檢測報告應(yīng)包括下述內(nèi)容： a)檢測機構(gòu)的名稱、地址和檢測完成的日期； b)本文件編號，如GB/T 25915.1—2021； c)清楚地標(biāo)明被測潔凈室或潔凈區(qū)的實際位置(必要時包括毗鄰的參照區(qū))及所有采樣點的坐標(biāo)(宜附圖)； d)規(guī)定的潔凈室或潔凈區(qū)表示法，其中包括ISO等級數(shù)、相關(guān)的占用狀態(tài)和關(guān)注粒徑； e)檢測方法的詳細(xì)說明，包括與檢測有關(guān)的特殊條件或?qū)z測方法的偏離情況，及檢測儀器的型號標(biāo)識和當(dāng)前的校準(zhǔn)證書； f)檢測結(jié)果，含全部采樣點的粒子濃度數(shù)據(jù)； g)如果大粒子的濃度已參照附錄C的說明作了量化，相關(guān)的信息也應(yīng)包含在檢測報告中。