EN ISO 14644-13:2017
(Main)Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications (ISO 14644-13:2017)
Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications (ISO 14644-13:2017)
ISO 14644-13:2017 gives guidelines for cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom and surfaces of materials in a cleanroom. Under consideration are all surfaces (external or internal) that are of interest. It provides guidance on the assessment of cleaning methods for achieving the required surface cleanliness by particle concentration (SCP) and surface cleanliness by chemical concentration (SCC) classes and which techniques should be considered to achieve these specified levels.
The appropriateness of cleaning techniques will make reference to the cleanliness classes and associated test methods found in ISO 14644‑9 and ISO 14644‑10.
The following matters of general guidance will be provided:
- expected surface cleanliness levels;
- suitability of cleaning methods;
- compatibility of surfaces with the cleaning technique;
- assessment of cleaning appropriateness.
The following will be excluded from this document:
- classification of cleaning methods;
- product produced within a cleanroom;
- specific surface-related cleaning methods;
- detailed description of cleaning mechanisms, methods and procedures of various cleaning methods;
- detailed material characteristics;
- description of damage mechanisms by cleaning processes and time-dependent effects;
- references to interactive bonding forces between contaminants and surfaces or generation processes that are usually time-dependent and process-dependent;
- other characteristics of particles such as electrostatic charge, ionic charges, etc.;
- chemical reactions between molecular contaminants and surfaces;
- microbiological aspects of surface cleanliness;
- radioactive aspects of contamination;
- health and safety considerations;
- environmental aspects such as waste disposal, emissions, etc.;
- selection and use of statistical methods.
Reinräume und zugehörige Reinraumbereiche - Teil 13: Reinigung von Oberflächen zur Erreichung definierter Reinheitsgrade hinsichtlich Partikel- und Chemikalienklassifikationen (ISO 14644-13:2017)
Die Norm behandelt die Reinigung von Reinraumoberflächen, Oberflächen der Ausrüstung in einem Rein-raum und Oberflächen von Materialien in einem Reinraum bis zu einem festgelegten Grad. Sie gibt Anleitungen zur Bewertung von Reinigungsverfahren zum Erreichen der geforderten Klassen der partiku-lären Oberflächenreinheit (SCP, en: surface cleanliness by particle concentration) und der chemischen Oberflächenreinheit (SCC, en: surface cleanliness by chemical concentration) und in Bezug darauf, welche Techniken zum Erreichen dieser festgelegten Grade berücksichtigt werden sollten.
Die Wirksamkeit von Reinigungstechniken wird auf die Reinheitsklassen und die damit verbundenen Prüfverfahren aus ISO 14644 9:2012 und ISO 14644 10:2013 verweisen.
Die folgenden Aspekte der allgemeinen Anleitung werden vorausgesetzt:
die erwarteten Oberflächenreinheitsgrade;
die Eignung der Reinigungsverfahren;
die Kompatibilität von Oberflächen mit der Reinigungstechnik;
die Bewertung der Reinigungswirksamkeit.
Das Folgende wird in dieser Norm nicht berücksichtigt:
die Klassifizierung von Reinigungsverfahren;
das innerhalb eines Reinraum hergestellte Produkt;
die spezifische Oberfläche in Bezug auf die Reinigungsverfahren;
die detaillierte Beschreibung von Reinigungsmechanismen, -verfahren sowie Verfahrensweisen von verschiedenen Reinigungsverfahren;
die detaillierten Materialkenngrößen;
die Beschreibung von Mechanismen hinsichtlich von Schäden durch die Reinigungsprozesse und zeitabhängige Auswirkungen;
Verweisungen auf interaktive Bindungskräfte zwischen den Kontaminanten und Oberflächen oder Generierungsprozesse, die üblicherweise zeit- und prozessabhängig sind;
weitere Kenngrößen von Partikeln, beispielsweise elektrostatische Ladung, Ionenladungen usw.;
die chemischen Reaktionen zwischen molekularen Kontaminanten und Oberflächen;
die mikrobiologischen Aspekte der Oberflächenreinheit;
die radioaktiven Aspekte der Kontamination;
die Aspekte des Gesundheitsschutzes und der Arbeitssicherheit;
die Umweltaspekte, beispielsweise Abfallentsorgung, Emissionen usw.;
die Auswahl und Anwendung von statistischen Verfahren.
Salles propres et environnements maîtrisés apparentés - Partie 13: Nettoyage des surfaces afin d'obtenir des niveaux de propreté par rapport aux classifications particulaire et chimique (ISO 14644-13:2017)
ISO 14644-13:2017 donne des lignes directrices concernant le nettoyage, jusqu'à atteindre un degré de nettoyage spécifié, des surfaces d'une salle propre ainsi que des surfaces des équipements et des matériaux contenus dans une salle propre. Toutes les surfaces d'intérêt (internes ou externes) sont concernées par le présent document. Il fournit des préconisations concernant l'évaluation des méthodes de nettoyage en vue d'obtenir les classes exigées de propreté particulaire des surfaces (SCP) et de propreté chimique des surfaces (SCC) ainsi que les techniques qu'il convient d'utiliser pour atteindre ces niveaux spécifiés.
L'adéquation des techniques de nettoyage fera référence aux classes de propreté et aux méthodes d'essai associées disponibles dans l'ISO 14644‑9 et l'ISO 14644‑10.
Les préconisations générales porteront sur les questions suivantes:
- niveaux de propreté des surfaces souhaités;
- pertinence des méthodes de nettoyage;
- compatibilité des surfaces avec la technique de nettoyage;
- évaluation de l'adéquation du nettoyage.
Les points suivants ne seront pas traités dans le présent document:
- classification des méthodes de nettoyage;
- produits fabriqués dans une salle propre;
- méthodes de nettoyage spécifiques en lien avec une surface;
- description détaillée des mécanismes de nettoyage, méthodes et modes opératoires de diverses méthodes de nettoyage;
- caractéristiques détaillées des matériaux;
- description des mécanismes de détérioration dus aux procédés de nettoyage et effets dans le temps;
- références aux forces de liaison entre les contaminants et les surfaces, ou aux processus de génération qui dépendent généralement du temps et du procédé;
- autres caractéristiques des particules, telles que la charge électrostatique, les charges ioniques, etc.;
- réactions chimiques entre les contaminants moléculaires et les surfaces;
- aspects microbiologiques de la propreté des surfaces;
- aspects radioactifs de la contamination;
- considérations relatives à la santé et la sécurité;
- aspects environnementaux tels que l'élimination des déchets, les émissions, etc.;
- sélection et utilisation de méthodes statistiques.
Čiste sobe in podobna nadzorovana okolja - 13. del: Čiščenje površin za doseganje določenih ravni čistoče po klasifikaciji delcev in kemikalij (ISO 14644-13:2017)
Ta del standarda ISO 14644 obravnava čiščenje (odstranjevanje kontaminantov) v določeni meri na površinah čistih prostorov, površinah opreme v čistih prostorih in površinah materialov v čistih prostorih.
Iz tega dokumenta so izključeni:
• čiščenje izdelkov in postopkov;
• čiščenje mikrobiološke kontaminacije;
• podrobne metode in postopki čiščenja.
V tem delu standarda ISO 14644 so podane smernice o različnih metodah čiščenja, ki so razvrščene, npr. mokro/suho in fizično/kemično.
V tem delu standarda ISO 14644 so podane smernice o metodah, ki naj bi se jih uporabilo za doseganje zahtevane čistosti površine s koncentracijo delcev (SCP) in čistočo površine s kemičnimi koncentracijami (SCC) in katere tehnike naj bi se upoštevalo, da te ravni dosežejo.
Učinkovitost tehnik čiščenja se nanaša na razrede čistoče in s tem povezane preskusne metode, ki jih najdemo v standardu ISO 14644-8, -9 in -10.
Zagotavlja naslednje splošne smernice:
• oceno škodljivih učinkov, kot so zdravstveni in varnostni vidiki,
lastnosti površine/materiala;
• združljivost površin s čistilno tehniko,
• površinske lastnosti, kot je morfologija;
• konfiguracije, kot so špranje, luknje in razpoke,
• odpadki in odplake
• primernost čistilnih sredstev in materialov (npr. čistost, snažnost, lastnosti)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2017
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Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to
achieve defined levels of cleanliness in terms of particle and chemical classifications
(ISO 14644-13:2017)
Reinräume und zugehörige Reinraumbereiche - Teil 13: Reinigung von Oberflächen zur
Erreichung definierter Reinheitsgrade hinsichtlich Partikel- und
Chemikalienklassifikationen (ISO 14644-13:2017)
Salles propres et environnements maîtrisés apparentés - Partie 13: Nettoyage des
surfaces afin d'obtenir des niveaux de propreté par rapport aux classifications
particulaire et chimique (ISO 14644-13:2017)
Ta slovenski standard je istoveten z: EN ISO 14644-13:2017
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 14644-13
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2017
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part
13: Cleaning of surfaces to achieve defined levels of
cleanliness in terms of particle and chemical classifications
(ISO 14644-13:2017)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 13: Nettoyage des surfaces afin d'obtenir des 13: Reinigung von Oberflächen zur Erreichung
niveaux de propreté par rapport aux classifications definierter Reinheitsgrade hinsichtlich Partikel- und
particulaire et chimique (ISO 14644-13:2017) Chemikalienklassifikationen (ISO 14644-13:2017)
This European Standard was approved by CEN on 26 May 2017.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-13:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14644-13:2017) has been prepared by Technical Committee ISO/TC 209
“Cleanrooms and associated controlled environments” in collaboration with Technical Committee
CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2018 and conflicting national standards shall
be withdrawn at the latest by February 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14644-13:2017 has been approved by CEN as EN ISO 14644-13:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-13
First edition
2017-06
Cleanrooms and associated controlled
environments —
Part 13:
Cleaning of surfaces to achieve defined
levels of cleanliness in terms of
particle and chemical classifications
Salles propres et environnements maîtrisés apparentés —
Partie 13: Nettoyage des surfaces afin d’obtenir des niveaux de
propreté par rapport aux classifications particulaire et chimique
Reference number
ISO 14644-13:2017(E)
©
ISO 2017
ISO 14644-13:2017(E)
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved
ISO 14644-13:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General methodology . 3
4.1 Overview . 3
4.2 Methodology . 4
5 Object description . 6
6 Cleanliness specifications . 7
7 Determination of initial contamination level . 7
7.1 General . 7
7.2 Determination of initial contamination level with respect to particle concentration . 7
7.3 Determination of initial contamination level with respect to chemical concentration. 7
8 Other requirements . 8
9 Selection of a cleaning methodology . 8
9.1 Selection procedure . 8
9.2 Cleaning methodologies . 8
9.2.1 Cleaning method . 8
9.2.2 Categories of cleaning techniques . 8
9.3 Cleaning process . 9
10 Material compatibility check . 9
11 Cleaning validation .10
11.1 General .10
11.2 Cleaning efficiency .11
11.2.1 Evaluation .11
11.2.2 Cleaning efficiency with respect to particle concentration .11
11.2.3 Cleaning efficiency with respect to chemical contamination .12
11.3 Cleaning appropriateness .13
11.3.1 Assessment .13
11.3.2 Cleaning appropriateness with respect to particle concentration .13
11.3.3 Cleaning appropriateness with respect to chemical concentration .14
12 Measurement methods .15
12.1 General .15
12.2 Direct measurement methods .15
12.2.1 General.15
12.2.2 Direct measurement methods with respect to SCP .16
12.2.3 Direct measurement methods with respect to SCC .16
12.3 Indirect measurement methods .16
12.3.1 General.16
12.3.2 Indirect measurement methods with respect to SCP .16
12.3.3 Indirect measurement methods with respect to SCC .17
13 Documentation .17
Annex A (informative) Aspects of cleaning .18
Annex B (informative) Cleaning methods .
...
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