SIST EN ISO 14644-18:2023

Cleanrooms and associated controlled environments - Part 18: Assessment of suitability of consumables (ISO 14644-18:2023)

This document gives guidance for assessing personal and non-personal consumables for their
appropriate use in cleanrooms, clean zones or controlled zones, based on product and process
requirements, cleanliness attributes and functional performance properties. The cleanliness attributes
addressed are particles or chemicals in air or on surfaces. Biocontamination (viable particles,
microorganisms or pyrogens) is considered as a special property of consumables. Identification of
associated risks are considered.
This document complements cleanroom operation as outlined in ISO 14644-5.
This document gives guidance concerning:
— determination of cleanroom suitability of consumables in general;
— specification of requirements for an intended use of a consumable by the customer with respect to
functional performance, cleanliness attributes and special properties;
— specification of properties for a designed use of a consumable by supplier;
— assessment of a consumable for an appropriate use;
— documentation.
Informative annexes are used to list examples for personal and non-personal consumables, verification
methods for cleanliness attributes testing and the potential impact of consumables on a cleanroom.
Cleaning agents, disinfectants and lubricants are considered as consumables with respect to
their packaging, as their packaging is likely to have cleanliness requirements in common with all
consumables.
This document does not apply to:
— design details of consumables;
— testing of functional performance of materials, e.g. barrier properties of gloves, wear and slip
resistance of flooring;
— health and safety requirements; legal requirements can apply in specific countries;
— cleanability;
— (raw) materials which are added within the production process as ingredients;
— performance or function testing;
— transport containers;
— process media such as gases or liquids;
— the functional performance of cleaning agents, disinfectants and lubricants.

Reinräume und zugehörige Reinraumbereiche - Teil 18: Bewertung der Reinraumtauglichkeit von Verbrauchsgegenständen (ISO 14644-18:2023)

Dieses Dokument bietet eine Anleitung für die Bewertung persönlicher und nicht persönlicher Verbrauchsgegenstände für ihre geeignete Verwendung in Reinräumen, reinen Bereichen oder kontrollierten Bereichen auf der Grundlage der Produkt- und Prozessanforderungen, der Reinheitsattribute und der funktionalen Leistungseigenschaften. Die behandelten Reinheitsattribute sind Partikel oder Chemikalien in der Luft oder auf Oberflächen. Biokontamination (lebensfähige Partikel/Mikroorganismen oder Pyrogene) gilt als besondere Eigenschaft von Verbrauchsgegenständen. Die Identifizierung der damit verbundenen Risiken wird berücksichtigt.
Dieses Dokument ergänzt den in ISO 14644 5 beschriebenen Reinraumbetrieb.
Dieses Dokument bietet eine Anleitung für:
   die Bestimmung der allgemeinen Reinraumtauglichkeit von Verbrauchsgegenständen;
   die Spezifikation von Anforderungen an die bestimmungsgemäße Verwendung eines Verbrauchsgegenstandes durch den Kunden im Hinblick auf die funktionale Leistung, Reinheitsattribute und besondere Eigenschaften;
   die Spezifikation von Eigenschaften für eine vorgesehene Verwendung eines Verbrauchsgegenstandes durch den Lieferanten;
   die Bewertung eines Verbrauchsgegenstandes für eine geeignete Verwendung;
   die Dokumentation.
Informative Anhänge werden verwendet, um Beispiele für persönliche und nicht persönliche Verbrauchsgegenstände, Überprüfungsverfahren für Reinheitsattribute und die potentielle Auswirkung von Verbrauchsgegenständen auf einen Reinraum aufzuführen.
Reinigungsmittel, Desinfektionsmittel und Schmierstoffe werden im Hinblick auf ihre Verpackung als Verbrauchsgegenstände betrachtet, da an ihre Verpackung wahrscheinlich die gleichen Reinheitsanforderungen bestehen, wie für alle Verbrauchsgegenstände.
Dieses Dokument ist nicht anwendbar für:
   Gestaltungsdetails von Verbrauchsgegenständen;
   die Prüfung der funktionalen Leistung von Materialien, z. B. Barriereeigenschaften von Handschuhen, Verschleiß- und Rutschfestigkeit von Bodenbelag;
   Gesundheits- und Sicherheitsanforderungen; in bestimmten Ländern können gesetzliche Anforderungen gelten;
   Reinigungsfähigkeit;
   (Roh-) Materialien, die innerhalb des Produktionsprozesses als Inhaltsstoffe hinzugefügt werden;
   Leistungs- oder Funktionsprüfungen;
   Transportbehälter;
   Prozessmittel wie Gase oder Flüssigkeiten;

Salles propres et environnements maîtrisés apparentés - Partie 18: Évaluation de l’aptitude à l’emploi des consommables (ISO 14644-18:2023)

Čiste sobe in podobna nadzorovana okolja - 18. del: Ocena ustreznosti potrošnih materialov (ISO 14644-18:2023)

Ta dokument podaja smernice za ocenjevanje osebnega in neosebnega potrošnega materiala glede njegove ustrezne uporabe v čistih sobah, čistih območjih ali nadzorovanih območjih na podlagi zahtev za izdelek in proces, atributov čistosti in funkcionalnih lastnosti delovanja. Obravnavani atributi čistosti
so delci ali kemikalije v zraku ali na površinah. Biokontaminacija (živi delci, mikroorganizmi ali pirogeni) velja za posebno lastnost potrošnih materialov. Upoštevana je identifikacija povezanih tveganj.
Ta dokument dopolnjuje delovanje čiste sobe, kot je določeno v standardu ISO 14644-5.
Dokument podaja smernice za:
– določanje ustreznosti čiste sobe za potrošne materiale na splošno;
– specifikacijo zahtev za predvideno uporabo potrošnega materiala s strani stranke v smislu
funkcionalnega delovanja, atributov čistosti in posebnih lastnosti;
– specifikacijo lastnosti za predvideno uporabo potrošnega materiala s strani dobavitelja;
– oceno potrošnega materiala za ustrezno uporabo;
– dokumentacijo.
Informativne priloge se uporabljajo za navedbo primerov osebnih in neosebnih potrošnih materialov, metod preverjanja za preskušanje atributov čistosti in potencialnih vplivov potrošnih materialov na čisto sobo. Čistilna sredstva, razkužila in maziva se štejejo za potrošni material glede na njihovo embalažo, saj mora embalaža najverjetneje izpolnjevati podobne zahteve glede čistoče kot vsi potrošni materiali.
Ta dokument se ne uporablja za:
– zasnovne podrobnosti potrošnega materiala;
– preskušanje funkcionalnih lastnosti materialov, npr. pregradne lastnosti rokavic, obraba in odpornost talnih oblog
proti zdrsu;
– zdravstvene in varnostne zahteve; v določenih državah lahko veljajo pravne zahteve;
– možnost čiščenja;
– (surovine) materiale, ki so dodani v proizvodnem procesu kot sestavine;
– preskušanje uspešnosti ali delovanja;
– transportne zabojnike;
– procesne medije, kot so plini ali tekočine;
– funkcionalno delovanje čistilnih sredstev, razkužil in maziv.

General Information

• Status: Published
• Public Enquiry End Date: 21-Dec-2022
• Publication Date: 05-Nov-2023
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 03-Nov-2023
• Due Date: 08-Jan-2024
• Completion Date: 06-Nov-2023
• Ref Project: EN ISO 14644-18:2023 - Cleanrooms and associated controlled environments - Part 18: Assessment of suitability of consumables (ISO 14644-18:2023)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14644-18:2023
01-december-2023
Čiste sobe in podobna nadzorovana okolja - 18. del: Ocena ustreznosti potrošnih
materialov (ISO 14644-18:2023)
Cleanrooms and associated controlled environments - Part 18: Assessment of suitability
of consumables (ISO 14644-18:2023)
Reinräume und zugehörige Reinraumbereiche - Teil 18: Bewertung der
Reinraumtauglichkeit von Verbrauchsgegenständen (ISO 14644-18:2023)
Salles propres et environnements maîtrisés apparentés - Partie 18: Évaluation de
l’aptitude à l’emploi des consommables (ISO 14644-18:2023)
Ta slovenski standard je istoveten z: EN ISO 14644-18:2023
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-18:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14644-18:2023

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SIST EN ISO 14644-18:2023


EN ISO 14644-18
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2023
EUROPÄISCHE NORM
ICS 13.040.35
English Version

Cleanrooms and associated controlled environments - Part
18: Assessment of suitability of consumables (ISO 14644-
18:2023)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 18: Évaluation de l'aptitude à l'emploi des 18: Bewertung der Reinraumtauglichkeit von
consommables (ISO 14644-18:2023) Verbrauchsgegenständen (ISO 14644-18:2023)
This European Standard was approved by CEN on 17 September 2023.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-18:2023 E
worldwide for CEN national Members.

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SIST EN ISO 14644-18:2023
EN ISO 14644-18:2023 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 14644-18:2023
EN ISO 14644-18:2023 (E)
European foreword
This document (EN ISO 14644-18:2023) 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 April 2024, and conflicting national standards shall be
withdrawn at the latest by April 2024.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 14644-18:2023 has been app
...

SLOVENSKI STANDARD
oSIST prEN ISO 14644-18:2022
01-december-2022
Čiste sobe in podobna nadzorovana okolja - 18. del: Ocena ustreznosti potrošnih
materialov (ISO/DIS 14644-18:2022)
Cleanrooms and associated controlled environments - Part 18: Assessment of suitability
of consumables (ISO/DIS 14644-18:2022)
Reinräume und zugehörige Reinraumbereiche - Teil 18: Bewertung der
Reinraumtauglichkeit von Verbrauchsmaterialien (ISO/DIS 14644-18:2022)
Salles propres et environnements maîtrisés apparentés - Partie 18: Titre manque
(ISO/DIS 14644-18:2022)
Ta slovenski standard je istoveten z: prEN ISO 14644-18
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-18:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 14644-18:2022

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oSIST prEN ISO 14644-18:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14644-18
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-09-30 2022-12-23
Cleanrooms and associated controlled environments —
Part 18:
Assessment of suitability of consumables
ICS: 13.040.35
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
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RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 14644-18:2022
ISO/DIS 14644-18:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14644-18
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-09-30 2022-12-23
Cleanrooms and associated controlled environments —
Part 18:
Assessment of suitability of consumables
ICS: 13.040.35
This document is circulated as received from the committee secretariat.
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ii
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 14644-18:2022
ISO/DIS 14644-18:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references .
...