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CEN

FprEN ISO 14644-18

(Main)

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

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

N/A

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

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

General Information

Status
Not Published
Publication Date
19-Nov-2023
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
6055 - CEN Ratification completed (DOR) - Publishing
Start Date
17-Sep-2023
Due Date
21-Oct-2023
Completion Date
17-Sep-2023
Ref Project
kSIST FprEN ISO 14644-18:2023 - Cleanrooms and associated controlled environments - Part 18: Assessment of suitability of consumables (ISO/FDIS 14644-18:2023)

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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
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
IMPORTANT — Please use this updated version dated 2022-08-11, and
TECHNOLOGICAL, COMMERCIAL AND
discard any previous version of this DIS because Figure 1 was missing.
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14644-18:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 3 ----------------------
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.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 14644-18:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 4 ----------------------
oSIST prEN ISO 14644-18:2022
ISO/DIS 14644-18:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references .
...

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