EN ISO 14644-7:2004

Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004)

ISO 14644-7:2004 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5.
The application of ISO 14644-7:2004 takes into account the following limitations: user requirements are as agreed by customer and supplier; application-specific requirements are not addressed; specific processes to be accommodated in the separative-device installation are not specified; fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply.
ISO 14644-7:2004 is not applicable to full-suits.

Reinräume und zugehörige Reinraumbereiche - Teil 7: SD-Module (Reinlufthauben, Handschuhboxen, Isolatoren und Minienvironments) (ISO 14644-7:2004)

Dieser Teil der ISO 14644 legt die Mindestanforderungen an die Auslegung, die Ausführung, die Aufstellung, die Prüfung und die Abnahme von SD Modulen hinsichtlich der Aspekte fest, in denen diese von Reinräumen nach ISO 14644 4 und 14644 5 abweichen.
Bei der Anwendung dieses Teils der ISO 14644 werden die folgenden Einschränkungen berücksichtigt:
-   Benutzerspezifische Anforderungen gelten wie zwischen Kunde und Lieferant vereinbart.
-   Anwendungsspezifische Anforderungen werden nicht betrachtet.
-   Bestimmte Prozesse, die bei der Aufstellung des SD Moduls aneinander angepasst werden müssen, sind nicht festgelegt.
-   Brandschutztechnische, sicherheitstechnische und andere behördliche Vorschriften werden nicht gesondert betrachtet; sofern angemessen, gelten die entsprechenden nationalen und lokalen Vorschriften.
Dieser Teil der ISO 14644 ist nicht auf Vollanzüge anwendbar.

Salles propres et environnements maîtrisés apparentés - Partie 7: Dispositifs séparatifs (postes à air propre, boîtes à gants, isolateurs et mini-environnements) (ISO 14644-7:2004)

L'ISO 14644-7:2004 spécifie les exigences minimales de conception, de construction, d'installation, d'essai et de réception des dispositifs séparatifs pour les aspects qui les différencient des salles propres telles qu'elles sont décrites dans l'ISO 14644-4 et dans l'ISO 14644-5.
L'application de l'ISO 14644-7:2004 est sujette aux limitations suivantes: les exigences particulières à telle ou telle application ne sont pas spécifiées; les exigences de l'utilisateur sont celles convenues entre le client et le fournisseur; les procédés spécifiques qu'hébergera le dispositif séparatif ne sont pas spécifiés; les réglementations de sécurité et de protection incendie et toute autre exigence réglementaire ne font pas l'objet d'un examen particulier; il convient de se conformer aux réglementations nationales ou locales applicables; les scaphandres n'entrent pas dans son domaine d'application.

Čiste sobe in podobna nadzorovana okolja – 7. del: Zaprte enote (brezprašne komore, komore z rokavicami, izolatorji, mini okolja) (ISO 14644-7:2004)

General Information

• Status: Published
• Publication Date: 30-Sep-2004
• ICS: 13.040 - Air quality
• Technical Committee: CEN/TC 243 - Cleanroom technology
• Drafting Committee: CEN/TC 243 - Cleanroom technology
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 31-Jul-2009
• Completion Date: 31-Jul-2009
• Ref Project: SIST EN ISO 14644-7:2005 - Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004)

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2005
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMD±GHO=DSUWHHQRWHEUH]SUDãQH
NRPRUHNRPRUH]URNDYLFDPLL]RODWRUMLPLQLRNROMD,62
Cleanrooms and associated controlled environments - Part 7: Separative devices (clean
air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004)
Reinräume und zugehörige Reinraumbereiche - Teil 7: SD-Module (Reinlufthauben,
Handschuhboxen, Isolatoren und Minienvironments) (ISO 14644-7:2004)
Salles propres et environnements maîtrisés apparentés - Partie 7: Dispositifs séparatifs
(postes a air propre, boîtes a gants, isolateurs et mini-environnements) (ISO 14644-
7:2004)
Ta slovenski standard je istoveten z: EN ISO 14644-7:2004
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.

EUROPEAN STANDARD
EN ISO 14644-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2004
ICS 13.040.35
English version
Cleanrooms and associated controlled environments - Part 7:
Separative devices (clean air hoods, gloveboxes, isolators and
mini-environments) (ISO 14644-7:2004)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 7: SD-
Partie 7: Dispositifs séparatifs (postes à air propre, boîtes à Module (Reinlufthauben, Handschuhboxen, Isolatoren und
gants, isolateurs et mini-environnements) (ISO 14644- Minienvironments) (ISO 14644-7:2004)
7:2004)
This European Standard was approved by CEN on 1 July 2004.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-7:2004: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 14644-7:2004) 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 2005, and conflicting national
standards shall be withdrawn at the latest by April 2005.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 14644-7:2004 has been approved by CEN as EN ISO 14644-7:2004 without any
modifications.
INTERNATIONAL ISO
STANDARD 14644-7
First edition
2004-10-01
Cleanrooms and associated controlled
environments —
Part 7:
Separative devices (clean air hoods,
gloveboxes, isolators and mini-
environments)
Salles propres et environnements maîtrisés apparentés —
Partie 7: Dispositifs séparatifs (postes à air propre, boîtes à gants,
isolateurs et mini-environnements)

Reference number
ISO 14644-7:2004(E)
©
ISO 2004
ISO 14644-7:2004(E)
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ii © ISO 2004 – All rights reserved

ISO 14644-7:2004(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Requirements . 3
5 Design and construction. 5
6 Access devices . 6
6.1 Use. 6
6.2 Manual operation . 6
6.3 Robotic handling. 7
7 Transfer devices. 7
7.1 Use. 7
7.2 Selection . 7
7.3 Fail-safe design . 7
8 Siting and installing. 7
9 Testing and approval. 8
9.1 General. 8
9.2 Glove breach test. 8
9.3 Operating differential pressure . 8
9.4 Leak testing . 8
9.5 Periodic testing . 9
Annex A (informative) Separation continuum concept . 10
Annex B (informative) Air-handling systems and gas systems. 13
Annex C (informative) Access devices. 16
Annex D (informative) Examples of transfer devices . 22
Annex E (informative) Leak testing. 31
Annex F (informative) Parjo leak test method . 40
Bibliography . 51

ISO 14644-7:2004(E)
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 14644-7 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 testing and monitoring to prove continued compliance with ISO 14644-1
 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)
The following parts are under preparation:
 Part 3: Test methods
 Part 8: Classification of airborne molecular contamination

iv © ISO 2004 – All rights reserved

ISO 14644-7:2004(E)
Introduction
In the spirit of the generic requirements of an International Standard, the term “separative devices” was
developed by Technical Committee ISO/TC 209 to encompass the wide continuum of configurations from
open unrestricted air overspill to wholly contained systems. Common terms-of-trade, such as clean air hoods,
gloveboxes, isolators and mini-environments, have different meanings depending on the specific industry.
Difficulties experienced in the manufacture and handling of certain products or materials have driven the
development of separative devices. These difficulties include product sensitivity to particles, chemicals, gases
or microorganisms; operator sensitivity to the process materials or byproducts; and both product and operator
sensitivity.
Separative devices provide assured protection in varying levels by utilising physical or dynamic barriers, or
both, to create separation between operation and operator. Certain processes may require special
atmospheres to prevent degradation or explosions. Some systems may be capable of providing 100 %
recirculation of the contained atmosphere to allow inert gas operation or biodecontamination with reactive
gases.
Usually people do not work directly inside the separative-device environment during production. These
separative devices may be movable or fixed, and used for transport, transfer and process. The product or
process, or both, are manipulated remotely with access devices either manually, with protection by barrier
technology such as wall-integrated personal interface systems (e.g. gloves, gauntlets, half-suits), or
mechanically with robotic handling syst
...