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BS EN ISO 14644-4:2001

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Cleanrooms and associated controlled environments Design, construction and start-up
Available format(s)

Hardcopy , PDF

Superseded date

12-08-2022

Language(s)

English

Published date

09-15-2001

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.

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.

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

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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