BS EN ISO 14644-4:2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 Design, construction and start-up
Hardcopy , PDF
08-12-2022
English
15-09-2001
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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
Describes requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements.
| Committee |
LBI/30
|
| DevelopmentNote |
Supersedes BS 5295-2(1989) & 97/120046 DC (08/2001)
|
| DocumentType |
Standard
|
| Pages |
64
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
This part of ISO14644 specifies requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements. It is intended for use by purchasers, suppliers and designers of cleanroom installations and provides a checklist of important parameters of performance. Construction guidance is provided, including requirements for start-up and qualification. Basic elements of design and construction needed to ensure continued satisfactory operation are identified through the consideration of relevant aspects of operation and maintenance.
NOTE Further guidance in respect of the above requirements is given in annexesA to H. Other parts of ISO14644 may provide complementary information.
Application of this part of ISO14644 is restricted in the following:
-
user requirements are represented by purchaser or specifier;
-
specific processes to be accommodated in the cleanroom installation are not specified;
-
fire and safety regulations are not considered specifically; the appropriate national and local requirements should be respected;
-
process media and utility services are only considered with respect to their routing between and in the different zones of cleanliness;
-
regarding initial operation and maintenance, only cleanroom construction-specific requirements are considered.
| Standards | Relationship |
| ONORM 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 |
| DIN EN ISO 14644-4:2003-06 | 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 |
| 12/30240811 DC : 0 | BS 8568 - CLEANROOM ENERGY - CODE OF PRACTICE FOR IMPROVING ENERGY EFFICIENCY IN CLEANROOMS AND CLEAN AIR DEVICES |
| PD 6609:2007 | Environmental cleanliness in enclosed spaces. Guide to in situ high efficiency filter leak testing |
| BS 8568:2013 | Cleanroom energy. Code of practice for improving energy efficiency in cleanrooms and clean air devices |
| BS 5N 100-7:2002 | Aircraft oxygen systems and equipment Guide to cleaning labelling and packaging |
| ISO 9004-1:1994 | Quality management and quality system elements Part 1: Guidelines |
| VDI 2083 Blatt 2:2015-04 | Cleanroom technology - Stipulations regarding the checking and monitoring of continued compliance with specifications |
| 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 1822-5:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 5: Determining the efficiency of filter elements |
| ISO 1940-1:2003 | Mechanical vibration Balance quality requirements for rotors in a constant (rigid) state Part 1: Specification and verification of balance tolerances |
| EN 779:2012 | Particulate air filters for general ventilation - Determination of the filtration performance |
| EN 1822-2:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 2: Aerosol production, measuring equipment, particle counting statistics |
| VDI 2083 Blatt 4:1996-02 | Cleanroom technology - Surface cleanliness |
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
| ISO 3746:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane |
| ISO 14004:2016 | Environmental management systems General guidelines on implementation |
| ISO 14644-3:2005 | Cleanrooms and associated controlled environments Part 3: Test methods |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO 10816-1:1995 | Mechanical vibration Evaluation of machine vibration by measurements on non-rotating parts Part 1: General guidelines |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 7730:2005 | Ergonomics of the thermal environment — Analytical determination and interpretation of thermal comfort using calculation of the PMV and PPD indices and local thermal comfort criteria |
| EN 1822-3:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 3: Testing flat sheet filter media |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| EN 1822-1:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking |
| EN 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 (ISO 14644-2:2015) |
| EN ISO 14644-1:2015 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) |
| EN 1822-4:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 4: Determining leakage of filter elements (scan method) |
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