EN ISO 14644-9:2012

Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012)

ISO 14644-9:2012 establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics are also given
ISO 14644-9:2012 applies to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environments, tools, equipment and products. The surface particle cleanliness (SPC) classification is limited to particles between 0,05 µm and 500 µm.
The following issues are not considered:
requirements for the cleanliness and suitability of surfaces for specific processes;
procedures for the cleaning of surfaces;
material characteristics;
references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent;
selection and use of statistical methods for classification and testing;
other characteristics of particles, such as electrostatic charge, ionic charges, microbiological state, etc.

Reinräume und zugehörige Reinraumbereiche - Teil 9: Klassifzierung der partikulären Oberflächenreinheit (ISO 14644-9:2012)

Der vorliegende Teil der ISO 14644 beschreibt die Klassifizierung der partikulären Reinheitsgrade auf festen Oberflächen für Anwendungen in Reinräumen und zugehörigen Reinraumbereichen. Empfehlungen zu Prüf  und Messverfahren sowie Angaben zu Oberflächenkenngrößen sind in den Anhängen A bis D enthalten.
Dieser Teil der ISO 14644 gilt für alle festen Oberflächen in Reinräumen und zugehörigen Reinraum¬bereichen, wie z. B. Wände, Decken, Fußböden, Arbeitsbereiche, Werkzeuge, Ausrüstungsgegenstände und Produkte. Die SCP Klassifizierung (Klassifizierung der partikulären Oberflächenreinheit, en: classification of surface cleanliness by particle concentration, SCP) ist auf Partikel mit einer Größe zwischen 0,05 µm und 500 µm begrenzt.
Folgende Aspekte werden in diesem Teil der Reihe ISO 14644 nicht betrachtet:
-   Anforderungen an die Reinheit und Eignung von Oberflächen für bestimmte Prozesse;
-   Verfahrensweisen für die Reinigung von Oberflächen;
-   Materialkenngrößen;
-   Bezüge auf die wechselseitigen Bindungskräfte oder Entstehungsprozesse, die üblicherweise zeitabhängig und prozessabhängig sind;
-   Auswahl und Anwendung statistischer Klassifizierungs  und Prüfverfahren;
-   weitere Kenngrößen von Partikeln, wie z. B. elektrostatische Ladung, Ionenladungen, mikrobiologischer Zustand usw.

Salles propres et environnements maîtrisés apparentés - Partie 9: Classification de la propreté des surfaces par la concentration de particules (ISO 14644-9:2012)

L'ISO 14644-9:2012 établit la classification des niveaux de propreté des surfaces solides par la concentration de particules, applicables aux salles propres et aux environnements maîtrisés apparentés. Des recommandations relatives aux essais et aux méthodes de mesurage, ainsi que des informations sur les caractéristiques des surfaces, sont également fournies.
L'ISO 14644-9:2012 s'applique à toutes les surfaces solides dans les salles propres et environnements maîtrisés apparentés tels que les murs, les plafonds, les sols, les environnements de travail, les outils, les équipements et les produits. La classification de la propreté des surfaces par concentration de particules (SCP) se limite à des tailles de particules comprises entre 0,05 µm et 500 µm.
L'ISO 14644-9:2012 n'aborde pas les points suivants:
les exigences pour la propreté et l'adéquation des surfaces à des processus spécifiques;
les modes opératoires de nettoyage des surfaces;
les caractéristiques des matériaux;
les références aux forces de liaison ou aux processus génération qui sont généralement fonction du temps et qui dépendent du procédé;
le choix et l'utilisation de méthodes statistiques pour la classification et les essais;
d'autres caractéristiques des particules, telles que la charge électrostatique, les charges ioniques, l'état microbiologique, etc.

Čiste sobe in podobna nadzorovana okolja - 9. del: Klasifikacija čistosti površine na osnovi koncentracije delcev (ISO 14644-9:2012)

Ta del standarda ISO 14644 določa klasifikacijo ravni čistosti na trdnih površinah s prisotnostjo delcev v čistih sobah in podobnih nadzorovanih okoljih. V dodatkih od A do D so navedena priporočila za preskušanje, merilne metode ter informacije o značilnostih površine. Ta del standarda ISO 14644 se uporablja za vse trdne površine v čistih sobah in podobnih nadzorovanih okoljih, kot so zidovi, stropi, tla, delovna okolja, orodja, oprema in izdelki. Klasifikacija čistosti površine s prisotnostjo delcev (SCP) je omejena na delce od 0,05 μm do 500 μm. Naslednja vprašanja niso obravnavana v tem delu standarda ISO 14644: – zahteve glede čistosti in primernosti površin za specifične postopke; – postopki čiščenja površin; – lastnosti materialov; – sklicevanja na interaktivne sile spajanja ali postopke tvorjenja, ki so običajno odvisni od časa in postopka; – izbira in uporaba statističnih metod za klasifikacijo in preskušanje; – druge značilnosti delcev, na primer elektrostatični naboj, naboji ionov, mikrobiološko stanje itd.

General Information

• Status: Withdrawn
• Publication Date: 14-Aug-2012
• Withdrawal Date: 24-May-2022
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: CEN/TC 243 - Cleanroom technology
• Drafting Committee: CEN/TC 243 - Cleanroom technology
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 25-May-2022
• Ref Project: SIST EN ISO 14644-9:2012 - Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012)

Relations

• Replaced By: EN ISO 14644-9:2022 - Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration (ISO 14644-9:2022)
• Effective Date: 25-Nov-2020

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Reinräume und zugehörige Reinraumbereiche - Teil 9: Klassifzierung der partikulären Oberflächenreinheit (ISO 14644-9:2012)Salles propres et environnements maîtrisés apparentés - Partie 9: Classification de la propreté des surfaces par la concentration de particules (ISO 14644-9:2012)Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012)13.040.35Brezprašni prostori in povezana nadzorovana okoljaCleanrooms and associated controlled environmentsICS:Ta slovenski standard je istoveten z:EN ISO 14644-9:2012SIST EN ISO 14644-9:2012en,fr01-oktober-2012SIST EN ISO 14644-9:2012SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 14644-9
August 2012 ICS 13.040.35 English Version
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012)
Salles propres et environnements maîtrisés apparentés - Partie 9: Classification de la propreté des surfaces par la concentration de particules (ISO 14644-9:2012)
Reinräume und zugehörige Reinraumbereiche - Teil 9: Klassifzierung der partikulären Oberflächenreinheit (ISO 14644-9:2012) This European Standard was approved by CEN on 14 August 2012.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14644-9:2012: ESIST EN ISO 14644-9:2012

Reference numberISO 14644-9:2012(E)© ISO 2012
INTERNATIONAL STANDARD ISO14644-9First edition2012-08-15Cleanrooms and associated controlled environments — Part 9: Classification of surface cleanliness by particle concentration Salles propres et environnements maîtrisés apparentés — Partie 9: Classification de la propreté des surfaces par la concentration de particules
ISO 14644-9:2012(E)
©
ISO 2012 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56  CH-1211 Geneva 20 Tel.
+ 41 22 749 01 11 Fax
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ii © ISO 2012 – All rights reserved
ISO 14644-9:2012(E) © ISO 2012 – All rights reserved iii Contents Page Foreword . iv Introduction . v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions . 1 4 Abbreviated terms . 2 5 Classification system . 3 5.1 ISO-SCP classification format . 3 5.2 Designation . 6 5.3 General information on surface cleanliness by particle concentration . 6 6 Demonstration of compliance . 6 6.1 Principle . 6 6.2 Testing . 6 6.3 Test report . 7 Annex A (informative)
Surface characteristics . 9 Annex B (informative)
Descriptor for specific particle size ranges . 12 Annex C (informative)
Parameters influencing the SCP classification . 15 Annex D (informative)
Measurement methods for determining surface cleanliness by particle concentration . 17 Bibliography . 25
ISO 14644-9:2012(E) iv © ISO 2012 – All rights reserved Foreword 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14644-9 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled environments:  Part 1: Classification of air cleanliness  Part 2: Specifications for monitoring to prove continued compliance with ISO 14644-1  Part 3: Test methods  Part 4: Design, construction and start-up  Part 5: Operations  Part 6: Vocabulary  Part 7: Separative devices (clean air hoods, gloveboxes, isolators, and mini-environments)  Part 8: Classification of air cleanliness by chemical concentration  Part 9: Classification of surface cleanliness by particle concentration  Part 10: Classification of surface cleanliness by chemical concentration Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments — Biocontamination control:  Part 1: General principles and methods  Part 2: Evaluation and interpretation of biocontamination data SIST EN ISO 14644-9:2012

ISO 14644-9:2012(E) © ISO 2012 – All rights reserved v Introduction Cleanrooms and associated controlled environments provide for the control of contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of contamination include those in such industries as aerospace, microelectronics, optics, nuclear, and life sciences (pharmaceuticals, medical devices, food, healthcare). ISO 14644-1 to ISO 14644-8 and ISO 14698-1 and ISO 14698-2 (biological contamination) deal exclusively with airborne particle and chemical contamination. Many factors, besides the classification of surface cleanliness, should be considered in the design, specification, operation and control of cleanrooms and other controlled environments. These factors are covered in some detail in other parts of ISO 14644 and ISO 14698. This part of ISO 14644 provides a classification for the determination and designation of surface cleanliness levels based on particle concentrations. This part of ISO 14644 also lists some methods of testing, as well as procedure(s) for determining the concentration of particles on surfaces. Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptations of the testing procedures might be required.
INTERNATIONAL STANDARD ISO 14644-9:2012(E) © ISO 2012 – All rights reserved 1 Cleanrooms and associated controlled environments — Part 9: Classification of surface cleanliness by particle concentration 1 Scope This part of ISO 14644 establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D. This part of ISO 14644 applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The classification of surface cleanliness by particle concentration (SCP) is limited to particles between 0,05 µm and 500 µm. The following issues are not considered in this part of ISO 14644:  requirements for the cleanliness and suitability of surfaces for specific processes;  procedures for the cleaning of surfaces;  material characteristics;  references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent;  selection and use of statistical methods for classification and testing;  other characteristics of particles, such as electrostatic charge, ionic charges, microbiological state, etc. 2 Normative references The following referenced documents are indispensable for the application 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. ISO 14644-6:2007, Cleanrooms and associated controlled environments — Part 6: Vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 14644-6:2007 and the following apply. 3.1 descriptor for specific particle size ranges differential descriptor that expresses SCP level within specific particle size ranges SIST EN ISO 14644-9:2012

ISO 14644-9:2012(E) 2 © ISO 2012 – All rights reserved NOTE The descriptor may be applied to particle size ranges of special interest or those particle size ranges that are outside the range of the classification system, and specified independently or as a supplement to the SCP classes. 3.2 direct measurement method assessment of the contamination without any intermediate steps 3.3 indirect measurement method assessment of the contamination with intermediate steps 3.4 solid surface boundary between the solid and a second phase 3.5 surface particle solid and/or liquid matter adhered and discretely distributed on a surface of interest, excluding film-like matt
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