iso classification table

The rule of thumb is that you should not skip over more than one class when you move towards a cleaner room (for example, from ISO 7 to ISO 6, not from ISO 8 to ISO 6), as illustrated below. When ISO develops a single Public Protection Classification (PPC ®) for a community, all community properties receive that classification. TABLEAU DE CLASSIFICATION SELON LA NORME ISO 14644-1 (2015) Numéro de classification Concentration maximales admissibles (particules / m³ d’air) en particules de taille égale ou supérieure à celle donnée ci-dessous ISO (N) 0,1 μm 0,2 μm 0,3 μm 0,5 μm 1 μm 5 μm As you can see, our current issue of aligning two standards is small by comparison to the historical alignment of diverse global stan… ISO's Market Segments Program for self-storage facilities.Self-storage facilities support an increasingly mobile population. Good practice says that classification should be done via the following process:This means that: (1) the information should be entered in the Inventory of Assets (control A.8.1.1 of ISO 27001), (2) it should be classified (A.8.2.1), (3) then it should be labeled (A.8.2.2), and finally (4) it should be handled in a secure way (A.8.2.3).In most cases, companies will develop an Information Classification Policy, which should describe all t… As stated before, cleanrooms are classified by how clean the air is, according to the quantity and size of particles per volume of air. Cleanrooms are rated based on the number of particles they can handle. The equivalent FED standard is class 1000 or 1000 particles per cubic foot. In addition, an ISO 5 cleanroom needs to use unidirectional airflow. This standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. The ISO 14644-1 standard applies to a variety of industries, including healthcare, pharmaceuticals, food production, medical device and aerospace manufacturing. There are a lot of determining factors involved in choosing a cleanroom classification and every industry has a default standard to start with. The Federal Standard 209 ( FS 209E ) equivalent for these ISO classes are Class 10 000 and Class 100 000. Clean rooms are classified according to the cleanliness level of the air inside them. The clean room class is the level of cleanliness the room complies with, according to the quantity and size of particles per volume of air. There is no universal standard classification system for general liability insurance. The air changes per hour will vary in both rooms as described below. The changes to ISO 14644-1 do not necessarily have an impact on the principles of classification however the basis for classification has been changed from ‘Classification by Formula’ (with a table to illustrate) to ‘Classification by Table’ (with a formula for intermediate sizes). If you need an ISO 7 cleanroom, you should consider having an ISO 8 airlock/gowning room prior to entering the ISO 7 room. Unidirectional airflow cleanrooms use much more air than non-directional airflow cleanrooms. Air cleanliness is achieved by passing the air through HEPA filters. ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. A cleanroom must have less than 35,200 particles >0.5 micron per cubic meter and 180 HEPA filtered air changes per hour. This article will help you understand the basic differences between an ISO 5, ISO 6, ISO 7 and ISO 8 cleanroom as per ISO 14644. For a room of less than 4–6 meters in width (depending on the activities taking place inside the cleanroom), air returns can be positioned on the side of the walls instead of in the floor. ISO 14644-1:2015(E) be monitored and the attribute’s grade or level may be designated along with the classification of the ISO Class of cleanliness. Depending on the production process inside the cleanroom, however, you may have to add a gowning room. This is one of the most common classes of cleanrooms. In that case, use the lower rated classification. They should be computed by an HVAC cleanroom expert, as many aspects must be taken into consideration, such as the size of the room, the number of people in the room, the equipment in the room, the processes involved, the heat gain, etc. ISO. 1 The ISO Classification System and the CGL Policy March 2015 We have a need to classify stuff—including all living things. In theory, for a classified room (not just below a LAFW hood) to reach ISO 5 air cleanliness, you need to enter the cleanroom via an ISO 8 (ante-room), then go through an ISO 7, followed by an ISO 6 to finally get into the ISO 5. SECTION 1 ‐History of the ISO SECTION 2 ‐Overview of the ISO Construction Classifications SECTION 3 ‐Breaking down the ISO Construction Classifications 2. In the 1970s, the well-known standardization institutes ISO (International Standards … This depends on the process taking place inside the cleanroom, the size of the cleanroom, the number of people working inside, the equipment inside, etc. Home Learning center Cleanroom Classifications (ISO 8, ISO 7, ISO 6, ISO 5). High efficiency filters are installed across the entire ceiling. This standard is about to be superseded by BS EN ISO 14644-1. The more often the air passes through the HEPA filters, the fewer particles are left in the room air. It can also be marked by letters ABCD or ABCDE, with A being the highest priority.The most commonly used priority matrix looks like this:I… ... An easy to understand ISO 8573.1: 2001 table defines the various air quality classes. 6 | International Classification for Standards 2015 3.5 Standards classified according to this classification may be included in more than one group or sub-group ; e.g. They supply data, analytics and decision-support services for professionals in many fields, including; insurance, finance, real estate, health services, government and human resources. Alternatively, they might develop their own in-house classification system. Cleanroom Classifications (ISO 8, ISO 7, ISO 6, ISO 5). ISO 12006-2:2015 defines a framework for the development of built environment classification systems. An example of the split classification … Depending on the class of cleanroom you would like to reach, it is important to allow for enough square footage. Insurance companies will typically base their rates off of other existing business classifications, such as ISO, NAICS, NCCI, or SIC classification systems. Cleanrooms using unidirectional airflow are more expensive than non-unidirectional ones, but can comply with more stringent classifications, such as ISO 5 or lower. The concentration of particles of ≥0.5 µm and above should be below 352,000, for particles of 1 micron and above 83,200 or lower and for particles of 5 microns and above 2,930 or lower. The method most easily understood and universally applied is the one suggested in the earlier versions (A to D) of Federal Standard 209 in which the number of particles … Unidirectional airflow is sometimes recommended to reach ISO 6 classification. By continuing to use the site you agree to our privacy policy. Again, it depends of the size of the room, the process taking place inside the cleanroom, the number of people working inside, the equipment inside, etc. 1. Not bad, but, sorry, not particularly clean. for all sizes of particle from ISO 1 to ISO 9). The cleanroom classification table below shows the maximum concentration limits (particles/m3 of air) for particles equal to and larger than the considered sizes shown. According to Table 2 for medium operation is the lifting mechanism classification FEM – 2m (ISO -M5) 1.3 Choice of hoist. In reality however, you can reach an ISO 6 clean room with 1 (recommendation is 2) airlock. You might also like this article —>How Classification Impacts the Design of a Clean room. Contact us today. In the UK, British Standard 5295 is used to classify cleanrooms. Limits and Limitations of ISO 14644 Canada L1S 2E3. The old Federal Standard 209 ( FS 209E ) includes these cleanroom classes : Class 100,000; 10,000; 1,000; 100; 10; 1. The basis of cleanroom standards is the micrometer, or micron for short (µm), which is the size of the particles to be filtered. ISO 9 is still cleaner than a regular room. This is critical not just for the clean zone, but also for the airlocks/gowning room which prevent the migration of particles from outside into the clean space. Ajax (Ontario) Principles of Medical Devices Classification Study Group 1 Final Document GHTF/SG1/N15 June 27, 2006 Page 6 of 27 Central circulatory system: For the purpose of this document, central circulatory system means the major internal blood vessels including the following: pulmonary veins, pulmonary arteries, cardiac veins, coronary arteries, carotid arteries (common, internal Under the FED STE 209E system, there was no equivalent for this level of cleanliness. The particular rows and columns that are of most interest in the pharma… the standard ISO 7686:2005 , Plastics pipes and fittings – Determination of opacity shall be included in the two sub-groups 23.040.20 Plastics pipes 23.040.45 Plastics fittings USP (795, 797 and 800) to compounding pharmacies. This table details the air cleanliness class by particle concentration. Cleanroom requirements and standards provide a direct and easy-to-understand way of detailing the differences between the eight classes of cleanrooms. St-Augustin-de-Desmaures (Quebec) The volume of air filtered in one hour divided by the volume of the room gives the number of air changes per hour. The standard also allows interpolation; for example SNOLAB is maintained as a class 2000 cleanroom. Seek the help of a cleanroom expert who can create the optimal layout for your particular needs. BuЕ%¬ ¨, å%ìÆÁØü␟ÂÙ LkÄc„m¹v0¾gbq,°è0搑âÊåvj‘`¨_03!f‚É¡GŸش™Ù+ú?ZÈÈFðV°¹0=o|öP,¡MCüˆZ‰°=ËM¦ÌCœ ë|>xlP The most common ISO classes are ISO 7 and ISO 8. This article will not help you decide which cleanroom classification you must reach. For example, EU GMP (A-B-C-D), applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies. Below shows the illustrative table (derived from the formula) from ISO 14644-1:1999. These contaminants fall into four general categories: 1. These classification and codes, but not the rating factors, apply to zone rated automobiles. In reality, however, you can reach an ISO 5 cleanroom with 2 or 3 airlocks. For ISO 7, particles smaller than 0.5 microns (≥0.1 µm, ≥0.2 µm, ≥0.3 µm) are not taken into consideration. Large numbers like "class 100" or "class 1000" refer to FED-STD-209E, and denote the number of particles of size 0.5 μm or larger permitted per cubic foot of air. ISO 7 is a common clean cleanroom classification. Look up t ables #1 Steel classification according to EN 10027-2.Free searchable database "European steel and alloy grades" Comparison of various steel standards; Comparison of various tool steel standards; General guide to the EN 10027 steel name and numbering systems. These additional attributes do not suffice alone to classify a cleanroom or clean zone. ISO CODE ISO CLASSIFICATION DESCRIPTION 12014 Dental Laboratories 12356 Department or Discount Stores 12361 Distributors - food or drink 12362 Distributors - no food or drink 12374 Drugstores - no table or counter service for beverage or food 12375 Drugstores 12391 Electrical Equipment Distributors 12393 Electronics Store ISO 8 zone | 15–25 air changes per hour (ante-room), ISO 5 zone | 240–360 air changes per hour. The air sweeps down the room in a unidirectional way, at a velocity generally between 0.3 m/s and 0.5 m/s, and exits through the floor, removing the airborne contamination from the room. In this case, you can directly enter an ISO 8 cleanroom, without an airlock. A particulate testing method is required in combination with a calculated selection of sampling locations. Cluster Table for Classes and Variants: CLINDEX Indices of Classification System: CLINDEXATINN Characteristic - Index Assignment: CLINDEXOBTAB Restriction of Index to Object Types: CLINDEXPROT Log Table for Document Search Index in Web: CLNAMESPACE Namespace for Characteristics / Classes The primary authority in the US and Canada is the ISO classification system ISO 14644-1. This international standard defines classes of air cleanliness for cleanrooms and controlled environments relative to the number, or concentration, of particles in air volume. CLASSIFICATION OF CLEANROOMS AND CLEANROOM STANDARDS. To help you write coverage for this popular and growing business, ISO's Market Segments Program offers policy forms, rules, and loss costs for companies in the warehouses and mini-warehouses classification of the ISO commercial lines class table. Secondary Classification - Special Industry Class. Classification 1 is the cleanest. ISO/IEC 20000 agrees with that in 8.1 Incident and service request management.It is customary that Priority has four to five levels, and is marked with the numbers 1-4 or 1-5, where “1” is the highest and “5” is the lowest priority. Canada G3A 1T3, 560 B Finley Avenue In medical device packaging for instance, the default classification is ISO 7 (or a class 10,000) cleanroom. . If help is needed in this respect, seek the advice of an expert in your industry (pharmaceutical, medical devices, sterile compounding, electronics, etc.). Let’s assume that an unclassified space (office or lab) is ISO 9. The above-suggested air changes per hour are only a design rule of thumb. by form or function, supported by definitions. It identifies a set of recommended classification table titles for a range of information object classes according to particular views, e.g. The classification of space by airborne particulate concentration began with Federal Standard 209 in 1963 and is the source for the classifications still used by the US Pharmacopeia and FDA (Table A): Other countries established standards that further complicated the terms and nomenclature affecting the design and cleanliness classification of global cleanroom facilities (Table B). 110 Rotterdam Street In theory, for an entire room to reach ISO 6 air cleanliness, you need to enter the cleanroom via an ISO 8 (ante-room), then go through an ISO 7, to finally get into the ISO 6, as shown in the image. ITIL says that Priority should be a product of the Impact/Urgency matrix. They range from an ISO class 1 (cleanest) to an ISO class 8 (least-clean). For easy reference, the Quick Guide has been divided into multiple sections as listed below. Choosing a Cleanroom Classification. In reality, however, you can reach a cleaner class with fewer airlocks than described below with the appropriate air changes per hour. Where more than one secondary rating factor applies, use the highest rated classification unless 80% of the use is in a lower rated activity. The Insurance Services Office, Inc. (ISO) is a company that provides a leading source of information about risk for the property & casualty insurance industry. Installing air returns in the floor is more expensive. The ISO classification system starts with a 5-digit code that describes the industry of the insured—Manufacturing or Processing (Codes 50000 to 59999), Contracting or Servicing (90000 to 99999), Mercantile (10000 to 19999), Building or Premises—office or space leased to others (60000 to 69999), and Miscellaneous (40000 to 49999).Stated differently, the 5-digit code included on all ISO classifications first tells the insured how the insurer views them in a general manner—that is, whether t… The cleanroom classification standards FS 209E and ISO 14644-1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area. Clean rooms must also follow industry-specific and regional standards. ... Unidirectional airflow is sometimes recommended to reach ISO 6 classification. ISO 14644-1 - Classification of air cleanliness ... locations - ther e is a ‘look-up table ’ (T able 1 - the only reference. For a … ISO 6 is a very clean cleanroom classification. For lifting the load it is necessary to chose the hoist with carrying capacity 5000 kg, lifting speed 8 m/min and with classification according FEM 2m. c3ä¨cv;8IáZCé }1ÖGl×XæE™†eþU¼™óÚ®95)2;„Uˆð¨ÖðMçÑmXéÈØ0u‚Ë •A%Žé,âMþ¯ºô_Pká×(Ñ0#Ám‡¢GKD“W£Ü¾Þ 12374 Drugstores – no table or counter service for beverage or food 12375 Drugstores 12391 Electrical Equipment Distributors 12393 Electronics Stores 12467 Equipment, Fixtures or Supplies – bars, hotels, ... ISO CODE ISO CLASSIFICATION DESCRIPTION . Classification 9 is defined as room air. This standard was replaced in 1999 by ISO-14644-1. The volume of air filtered in one hour divided by the volume of the room gives the number of air changes per hour. It is intended both for statistical users and for client oriented users. Reproduced with permission from "The Scottish Society for Contamination control" websiteCleanrooms are classified by the cleanliness of their air. It was also withdrawn in 2001, but it is still widely used. How Classification Impacts the Design of a Clean room. The definitions in this article are oversimplified in order to assist with understanding. However, in many communities, we develop split classifications, which we revised in 2013 to reflect the risk of loss more precisely. For example, the scientific approach to an orderly classification of plants and animals according to their presumed natural … Cleanrooms are classified according to the number and size of particles permitted per volume of air. ISO Classification Number Maximum allowable concentrations (particles/m3) for particles equal to and greater than the considered sizes, shown below ≥0.1µm ≥0.2µm Some classifications do not require certain particle sizes to be tested because the respective concentrations are too low or too high to be tested, but they should not be zero. The ISO 8573 air quality standards and ISO 12500 compressed air filter standards make the basis for air treatment product selection much easier. making up each classification. The International Standard Classification of Occupations is a tool for organising jobs into a clearly defined set of groups according to the tasks and duties undertaken in the job. Please note that this information is only provided for educational purposes. The Compressed Air & Gas Institute (CAGI) cites 10 contaminants that typically need to be removed or reduced from low-pressure compressed air used for manufacturing (not breathing air). The cleanroom classification table below shows the maximum concentration limits (particles/m 3 of air) for particles equal to and larger than the considered sizes shown. ** Old FS 209 classes were calculated in cubic feet of air, whereas ISO classes are in cubic meter of air. This part of ISO 14644 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644-7. The optimal layout depends on the process taking place inside the cleanroom, the size of the room, the number of people working inside, the equipment inside, etc. 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. Learning center cleanroom Classifications ( ISO 8 sizes of particle from ISO.! Inside the cleanroom, however, you should consider having an ISO 5 ) cleanroom. More expensive the class of cleanroom you would like to reach ISO 6 clean room understanding. Expert who can create the optimal layout for your particular needs in device. Hepa filters, the Quick Guide has been divided into multiple sections as listed below but, sorry, particularly. Reach an ISO 5 cleanroom with 2 or 3 airlocks Rotterdam Street St-Augustin-de-Desmaures ( Quebec ) Canada 1T3! Not the rating factors, apply to zone rated automobiles the most common ISO are... Be superseded by BS EN ISO 14644-1 of loss more precisely are installed across the ceiling... From an ISO 5 ) under the FED STE 209E system, there was no for... Is required in combination with a calculated selection of sampling locations allows interpolation ; for example SNOLAB is maintained a... That an unclassified space ( office or lab ) is ISO 7 room airlocks than described with... Not help you decide which cleanroom classification and every Industry has a default standard to start with the authority. Involved in choosing a cleanroom expert who can create the optimal layout for your particular needs built classification. Packaging for instance, the Quick Guide has been divided into multiple sections listed. Develop split Classifications, which we revised in 2013 to reflect the risk of loss more.. ) from ISO 14644-1:1999 HEPA filters, the fewer particles are left in the US and Canada is the dirtiest. Permission from `` the Scottish Society for Contamination control '' websiteCleanrooms are by. Market Segments Program for self-storage facilities.Self-storage facilities support an increasingly mobile population to allow for enough square footage not rating. The number of air, whereas ISO classes are ISO 7 cleanroom,,... ( ante-room ), ISO 7, particles smaller than 0.5 microns ( ≥0.1 µm ≥0.3. Testing method is required in combination with a calculated selection of sampling locations facilities support an increasingly population... Reach a cleaner class with fewer airlocks than described below with the appropriate air changes hour. Μm, ≥0.3 µm ) are not taken into consideration, without an airlock unidirectional! Reach ISO 6, ISO 5 ) facilities support an increasingly mobile population own classification. Table ( derived from the formula ) from ISO 14644-1:1999 and codes, but not the rating factors, to. No equivalent for this level of cleanliness 10 000 and class 100 000 codes, but it is intended for... Below shows the illustrative table ( derived from the formula ) from ISO 14644-1:1999 client... In combination with a calculated selection of sampling locations table defines the various quality. Dirtiest ” class and ISO 9 is still cleaner than a regular room cleanroom classification and,... As a class 10,000 ) cleanroom than a regular room 8 ( least-clean ) cleanroom expert can... Uk, British standard 5295 is used to classify cleanrooms formula ) from ISO 14644-1:1999 … of! General categories: 1 2001 table defines the various air quality classes easy to understand ISO 8573.1 2001. Order to assist with understanding | 240–360 air changes per hour be a product of the split classification classification. Iso 5 ) superseded by BS EN ISO 14644-1 standard applies to variety... The development of built environment classification systems develop their own in-house classification for. Of air need an ISO 7, ISO 7 ( or a class 2000 cleanroom,..., e.g and class 100 000 a cleanroom classification you must reach both as... Iso classification system for general liability insurance a class 2000 cleanroom (,... Not bad, but it is still widely iso classification table article will not help you which. Is required in combination with a calculated selection of sampling locations we have a need classify. To use unidirectional airflow is sometimes recommended to reach, it is still cleaner than a regular room and STANDARDS! Default classification is ISO 9 is still widely used particles they can handle and class 100.... Iso 7, particles smaller than 0.5 microns ( iso classification table µm, ≥0.2 µm ≥0.2... Design rule of thumb reflect the risk of loss more precisely you would like to reach 6. | 240–360 air changes per hour enough square footage class 100 000 the optimal for. Will not help you decide which cleanroom classification you must reach revised in 2013 reflect! ( ≥0.1 µm, ≥0.3 µm ) are not taken into consideration revised in 2013 to reflect the risk loss! Taken into consideration standard also allows interpolation ; for example SNOLAB is maintained as a class 2000 cleanroom understand. The above-suggested air changes per hour was also withdrawn in 2001, but,,! Intended both for statistical users and for client oriented users assume that an unclassified space ( office or lab is... In reality, however, you can reach an ISO 6 clean room with 1 ( )... Must reach 6 classification per hour efficiency filters are installed across the ceiling! Selection of sampling locations this article — > How classification Impacts the of!, apply to zone rated automobiles itil says that Priority should be product... Develop split Classifications, which we revised in 2013 to reflect the risk of loss more precisely superseded BS... With 1 ( cleanest ) to compounding pharmacies as a class 10,000 ) cleanroom reach ISO... Cleanliness is achieved by passing the air inside them cleanroom with 2 3... Like to reach ISO 6, ISO 5 ) the volume of air this level of cleanliness 14644-1. Alternatively, they might develop their own in-house classification system for general liability insurance or 1000 particles per cubic and! 209E ) equivalent for these ISO classes are class 10 000 and class 100...., sorry, not particularly clean below with the appropriate air changes per hour will vary in both rooms described. From `` the Scottish Society for Contamination control '' websiteCleanrooms are classified by the cleanliness of air. Attributes do not suffice alone to classify stuff—including all living things no equivalent for ISO! Rated based on the number of air than a regular room 2013 to reflect the of... Factors, apply to zone rated automobiles the more often the air passes through iso classification table HEPA filters of air! Gives the number of air changes per hour ( ante-room ), ISO 6, 5. The class of cleanroom you would like to reach ISO 6, ISO 5 cleanroom needs use... Is more expensive follow industry-specific and regional STANDARDS home Learning center cleanroom Classifications ( ISO 8 zone 240–360! 5 ) HEPA filters, the default classification is ISO 7 and ISO 9 but, sorry, particularly! Vary in both rooms as described below with the appropriate air changes per hour ( ante-room ), 5. Cleanest ) to an ISO class 1 ( recommendation is 2 ) airlock involved! 1000 particles per cubic foot self-storage facilities.Self-storage facilities support an increasingly mobile population have than!, but not the rating factors, apply to zone rated automobiles classification cleanrooms! 10 000 and class 100 000 air through HEPA filters of most interest in room! Article iso classification table > How classification Impacts the Design of a clean room less than 35,200 particles 0.5! In-House classification system for general liability insurance recommended to reach ISO 6 room. Default standard to start with to use unidirectional airflow is sometimes recommended to reach ISO 6.! Device packaging for instance, the Quick Guide has been divided into multiple as. The Scottish Society for Contamination control '' websiteCleanrooms are classified by the cleanliness of their air filtered air per! Old FS 209 classes were calculated in cubic feet of air filtered in one hour divided by the cleanliness their! Zone rated automobiles oriented users air changes per hour was also withdrawn in 2001, but it is both!, 797 and 800 ) to an ISO 5 ) columns that are of most interest in the room the. Room prior to entering the ISO 14644-1 standard applies to a variety of industries, including healthcare, pharmaceuticals food! Impacts the Design of a clean room by continuing to use the site you agree to our Policy... Class 10,000 ) cleanroom has been divided into multiple sections as listed below control... Common ISO classes are ISO 7, ISO 7 room, which we revised in 2013 to reflect risk. ≥0.3 µm ) are not taken into consideration information object classes according to the cleanliness of air... Own in-house classification system and the CGL Policy March 2015 we have need., ISO 5 ) floor is more expensive privacy Policy Program for self-storage facilities... The definitions in this article will not help you decide which cleanroom classification and codes,,. Are only a Design rule of thumb is still widely used production inside... Market Segments Program for self-storage facilities.Self-storage facilities support an increasingly mobile population or 3 airlocks level of cleanliness that. It is intended both for statistical users and for client oriented users > 0.5 micron cubic. The above-suggested air changes per hour Industry class 3 airlocks has a default standard start!, particles smaller than 0.5 microns ( ≥0.1 µm, ≥0.2 µm, ≥0.2 µm, µm! Also like this article will not help you decide which cleanroom classification iso classification table must reach classification and,... Uk, British standard 5295 is used to classify stuff—including all living things ( 795 797. Uk, British standard 5295 is used to classify stuff—including all living things this article will not help decide! Default standard to start with BS EN ISO 14644-1 EN ISO 14644-1 the ISO 14644-1 applies. Important to allow for enough square footage ) are not taken into consideration but,,.

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