DIN EN ISO 14644-4:2003-06
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001)
Hardcopy , PDF
02-04-2023
English, German
01-06-2003
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Planning and design
5.1 Planning procedure
5.2 Design
6 Construction and start-up
7 Testing and approval
7.1 General
7.2 Construction approval
7.3 Functional approval
7.4 Operational approval
8 Documentation
8.1 General
8.2 Record of an installation
8.3 Operational instructions
8.4 Instructions for performance monitoring
8.5 Maintenance instructions
8.6 Maintenance record
8.7 Record of operation and maintenance training
Annex A (informative) Control and segregation concepts
Annex B (informative) Classification examples
Annex C (informative) Approval of an installation
Annex D (informative) Layout of an installation
Annex E (informative) Construction and materials
Annex F (informative) Environmental control of cleanrooms
Annex G (informative) Control of air cleanliness
Annex H (informative) Additional specification of
requirements to be agreed upon between
purchaser/user and designer/supplier
Bibliography
This standard is included in DIN Handbook 406. Describes requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements.
| DocumentType |
Standard
|
| Pages |
57
|
| ProductNote |
THIS STANDARD REFERS TO : ISO 14698-3
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 14644-4 : 2001 | Identical |
| BS EN ISO 14644-4:2001 | Identical |
| NEN EN ISO 14644-4 : 2001 | Identical |
| UNE-EN ISO 14644-4:2001 | Identical |
| NF EN ISO 14644-4 : 2001 | Identical |
| EN ISO 14644-4:2001 | Identical |
| SN EN ISO 14644-4 : 2001 | Identical |
| NS EN ISO 14644-4 : 1ED 2001 | Identical |
| NBN EN ISO 14644-4 : 2001 | Identical |
| ISO 14644-4:2001 | Identical |
| I.S. EN ISO 14644-4:2001 | Identical |
| UNI EN ISO 14644-4 : 2004 | Identical |
| DIN HDBK 406 : 2ED 2016 | |
| 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) |
| VDI 2083 Blatt 18:2012-01 | Cleanroom technology - 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 12:2000-01 | Cleanroom technology - Safety and environmental aspects |
| DIN EN ISO 14644-3:2006-03 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS |
| DIN EN ISO 11737-2:2010-04 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
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