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I.S. EN ISO 14644-7:2004

Current

Current

The latest, up-to-date edition.

CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE DEVICES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS AND MINI-ENVIRONMENTS)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2004

€99.00
Excluding VAT

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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


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

Provides 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.

Committee
ISO/TC 209
DocumentType
Standard
Pages
64
PublisherName
National Standards Authority of Ireland
Status
Current

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ENV 1631 : 1996 CLEANROOM TECHNOLOGY - DESIGN, CONSTRUCTION AND OPERATION OF CLEANROOMS AND CLEAR AIR DEVICES
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
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ISO 10648-2:1994 Containment enclosures — Part 2: Classification according to leak tightness and associated checking methods
EN 12469:2000 Biotechnology - Performance criteria for microbiological safety cabinets

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€99.00
Excluding VAT