1、BRITISH STANDARD BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) The European Standard EN ISO 14644-7:2004 has the status of a British Standard ICS 13.040.35 BS EN ISO 14644-7:2004 This
2、 British Standard was published under the authority of the Standards Policy and Strategy Committee on 14 October 2004 BSI 14 October 2004 ISBN 0 580 44610 7 National foreword This British Standard is the official English language version of EN ISO 14644-7:2004. It is identical with ISO 14644-7:2004
3、The UK participation in its preparation was entrusted to Technical Committee LBI/30, Cleanroom technology, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement intern
4、ational or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purpo
5、rt to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee
6、 any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO f
7、oreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 52, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments EUROPEAN STANDARD NORME EUR
8、OPENNE EUROPISCHE NORM EN ISO 14644-7 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 matriss apparents - Parti
9、e 7: Dispositifs sparatifs (postes air propre, botes gants, isolateurs et mini-environnements) (ISO 14644- 7:2004) Reinrume und zugehrige Reinraumbereiche - Teil 7: SD- Module (Reinlufthauben, Handschuhboxen, Isolatoren und Minienvironments) (ISO 14644-7:2004) This European Standard was approved by
10、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
11、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 C
12、entral 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,
13、 Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2004 CEN All rights of exploitation in any form and by any
14、 means reserved worldwide for CEN national Members. Ref. No. EN ISO 14644-7:2004: E 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 tec
15、hnology“, 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. Ac
16、cording 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, Lith
17、uania, 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. ENISO146447:2004 Reference number ISO 14644-7
18、:2004(E)INTERNATIONAL STANDARD ISO 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 matriss apparents Partie 7: Dispositifs sparatifs (postes
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22、eratit gno it is f,dnuo plsaee inform ttneC ehlar Secrteiraat ta the serddaig sleb nevwo. ISO 4002 Athgir lls serevr.de selnUs towrehise specfidei, trap on fo thsi ilbupctanoi may cudorper ebtu ro dezilina ni dey fomr yb ro nam y,snae lecetrinoc m roecinahcal, inclidung tohpcoiypom dna gnicrfoilm, w
23、ittuoh mrepissii non writif gnrmo ietI rehSta O tserdda ehs ebolw or ISOs memreb i ydobn the cnuotrfo y ttseuqer ehe.r ISO cirypothg fofice saCe tsopale 65 eneG 1121-HC 02 av leT. 4 + 10 947 22 1 11 xaF0 947 22 14 + 9 74 E-mail coirypthgiso.o gr We bwww.is.o gro Published in Switzerland ii ENISO1464
24、47:2004 iiiContents 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
25、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.
26、 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 ENISO146447:2004iv Foreword ISO (the International Organization for Standardization) is a wo
27、rldwide 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 o
28、n 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
29、 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 Standa
30、rd 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 b
31、y 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 pr
32、ove 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 o
33、f airborne molecular contamination ENISO146447:2004 vIntroduction 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 overspi
34、ll 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 developme
35、nt 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 utilis
36、ing 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 operatio
37、n 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
38、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 systems. Air cleanliness definitions and test methods covered in ISO 14644-1, 14644-2 and 14644-3 gener
39、ally apply within separative devices. In applications with biological contamination requirements, ISO 14698-1 and 14698-2 will apply. However, some applications can have special requirements for monitoring because of extreme conditions that may be encountered. These unique conditions are covered in
40、this part of ISO 14644. Transfer devices to move material in and out of separative devices form an important portion of this part of ISO 14644. In addition, material can be moved from one fixed separative device to another in transport containers. Design and construction of cleanrooms, including gen
41、eric aspects of clean zones, are covered in ISO 14644-4. ISO 14644-4:2001, Figure A.4, illustrates aerodynamic measures or air overspill often used in industry-specific separative devices called clean air hoods and mini-environments. Mini-environments are often used in the electronics industry with
42、transport containers, called boxes or pods, to provide very clean process conditions. The application of barrier technology used in industry-specific separative devices called isolators is shown in ISO 14644-4:2001, Figure A.5. Separative devices, often called gloveboxes, containment enclosures or i
43、solators, are used in the medical products and nuclear industries to provide protection to the operator as well as the process. Isolators may be rigid- or soft-walled depending on the application. The Bibliography contains industry-specific references. However, from a unifying conceptual standpoint,
44、 a continuum of separation exists between the operation and the operator, ranging from totally open to totally enclosed systems depending on the application. Similarly, a continuum exists for containment. The concept of separative devices is not limited to one specific industry, as many industries u
45、se these technologies for different requirements. In that light, this part of ISO 14644 provides a generic overview of the requirements involved. ENISO146447:2004blank ENISO146447:2004INTENRATIONAL TSANDADR IS-44641 O7:(4002E)1Cleanrooms and associated controlled environments Part 7: Separative devi
46、ces (clean air hoods, gloveboxes, isolators and mini-environments) 1 Scope This part of ISO 14644 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 an
47、d 14644-5. The application of this part of ISO 14644 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 specif
48、ied. Fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply. This part of ISO 14644 is not applicable to full-suits. 2 Normative references The following referenced documents are indispensable for the application of this doc
49、ument. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10648-2:1994, Containment enclosures Part 2: Classification according to leak tightness and associated checking methods ISO 14644-1:1999, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness ISO 14644-2:2000, Cleanrooms
