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) (ISO 14644-7:2004)
01-10-2004
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
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.
| Committee |
CEN/TC 243
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| SS-EN ISO 14644-7 : 2004 | Identical |
| NEN EN ISO 14644-7 : 2004 | Identical |
| ISO 14644-7:2004 | Identical |
| I.S. EN ISO 14644-7:2004 | Identical |
| NF EN ISO 14644-7 : 2004 | Identical |
| NS EN ISO 14644-7 : 1ED 2005 | Identical |
| PN EN ISO 14644-7 : 2005 | Identical |
| BS EN ISO 14644-7:2004 | Identical |
| NBN EN ISO 14644-7 : 2004 | Identical |
| DIN EN ISO 14644-7:2005-01 | Identical |
| UNE-EN ISO 14644-7:2005 | Identical |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| DIN EN ISO 13408-1:2015-12 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| BS EN ISO 13408-1:2015 | Aseptic processing of health care products General requirements |
| PREN 17141 : DRAFT 2017 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| VDI 2083 Blatt 17:2013-06 | Cleanroom technology - Compatibility of materials with the required cleanliness |
| VDI 2083 Blatt 15:2007-04 | Cleanroom technology - Personnel at the clean work place |
| VDI 2083 Blatt 8.1:2014-10 | Cleanroom technology - Air cleanliness chemical concentration (ACC) |
| VDI 2083 Blatt 1:2013-01 | Cleanroom technology - Particulate air cleanliness classes |
| VDI 2083 Blatt 9.1:2006-12 | Clean room technology - Compatibility with required cleanliness and surface cleanliness |
| VDI 2083 Blatt 3:2005-07 | Cleanroom technology - Metrology and test methods |
| VDI 2083 Blatt 16.1:2010-08 | Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification |
| EN ISO 13408-1:2015 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| I.S. EN 17141:2020 | Cleanrooms and associated controlled environments - Biocontamination control |
| I.S. EN ISO 13408-1:2015 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
| 17/30329441 DC : 0 | BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| 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 |
| NFC 01 371 : 85 AMD 1 1999 | ELECTROTECHNICAL VOCABULARY - CHAPTER 371: TELECONTROL |
| 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 |
| ISO 13408-6:2005 | Aseptic processing of health care products — Part 6: Isolator systems |
| ISO 13408-5:2006 | Aseptic processing of health care products — Part 5: Sterilization in place |