I.S. EN ISO 14644-7:2004
Current
The latest, up-to-date edition.
CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE DEVICES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS AND MINI-ENVIRONMENTS)
Hardcopy , PDF
English
01-01-2004
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
|
| Standards | Relationship |
| ISO 14644-7:2004 | Identical |
| NEN EN ISO 14644-7 : 2004 | Identical |
| NF EN ISO 14644-7 : 2004 | Identical |
| BS EN ISO 14644-7:2004 | Identical |
| EN ISO 14644-7:2004 | Identical |
| NS EN ISO 14644-7 : 1ED 2005 | Identical |
| NBN EN ISO 14644-7 : 2004 | Identical |
| DIN EN ISO 14644-7:2005-01 | Identical |
| UNE-EN ISO 14644-7:2005 | Identical |
| EN 12298:1998 | Biotechnology - Equipment - Guidance on testing procedures for leaktightness |
| ISO 10648-1:1997 | Containment enclosures — Part 1: Design principles |
| ISO 14698-2:2003 | Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data |
| ISO 14644-2:2015 | Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
| EN 12307:1997 | Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel |
| ISO 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
| BS 3636:1963 | Methods for proving the gas tightness of vacuum or pressurized plant |
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods |
| ISO 14644-3:2005 | Cleanrooms and associated controlled environments — Part 3: Test methods |
| 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 |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration |
| EN 12296:1998 | Biotechnology - Equipment - Guidance on testing procedures for cleanability |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| 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 |
Access your standards online with a subscription
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.
Important note : Users cannot be edited or removed once added to your Multi user PDF.