Header
About this publication
Preface
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
4.14
4.15
4.16
4.17
4.18
5 Planning and design
5.1 Planning procedure
5.1.1
5.1.2
5.1.3
5.1.4
5.1.5
5.1.6
5.1.7
5.2 Design
5.2.1
5.2.2
5.2.3
6 Construction and start-up
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
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
A.1 Contamination control zones
A.2 Airflow patterns
A.2.1
A.2.2
A.2.3
A.2.4
A.3 Disturbance of unidirectional airflow
A.4 Contamination control concepts
A.5 Concepts to achieve segregation of cleanrooms and clean zones
A.5.1 General
A.5.2 Displacement concept (low pressure differential, high airflow)
A.5.3 Pressure differential concept (high pressure differential, low airflow)
A.5.4 Physical barrier concept
Annex B
B.1 Healthcare products
B.2 Microelectronics
B.3 Influence of cleanroom clothing
Annex C
C.1 Test preparation and final cleaning
C.2 Inspection, tests and approvals
C.2.1 General
C.2.2 Concept and design approval
C.2.3 Construction and installation approval
C.2.3.1 Construction approval (at supplier’s site)
C.2.3.2 Installation approval (at the site of the installation)
C.2.4 Functional approval
C.2.5 Operational approval (equipment installed in a manner agreed in advance)
C.3 Reports
Annex D
D.1 General considerations
D.1.1 Size
D.1.2 Workstation siting and organization
D.1.3 Ancillary areas and adjacent cleanrooms
D.1.4 Utility services and ancillary equipment
D.1.4.1 General
D.1.4.2 Vacuum-cleaning equipment
D.1.4.3 Sprinkler systems
D.1.5 Communication systems
D.1.6 Glazing
D.2 Access
D.2.1 General
D.2.2 Airlocks
D.2.3 Emergency exits
D.2.4 Changing rooms
D.2.4.1 General
D.2.4.2 Changing room control and configuration
D.2.4.3 Facilities in changing rooms
Annex E
E.1 Selection of materials
E.1.1 General
E.1.2 Surface cleanliness and cleanability of materials of construction
E.1.3 Control of electrostatic charging and discharge
E.1.4 Internal finishes, durability and maintainability
E.2 Considerations for specific components
E.2.1 Ceilings, walls and floors
E.2.1.1 Basic requirements
E.2.1.2 Ceilings
E.2.1.3 Walls and wall systems
E.2.1.4 Floors
E.2.2 Air-handling systems
E.2.3 Fittings in airlocks
E.2.4 Ancillary areas
E.3 Construction and assembly
E.3.1 General
E.3.2 Material management during construction
E.3.3 Cleanliness and cleaning during construction and start-up
E.4 Materials of construction
Annex F
F.1 Design
F.1.1
F.1.2
F.2 Temperature and humidity
F.2.1
F.2.2
F.2.3
F.2.4
F.2.5
F.2.6
F.2.7
F.2.8
F.2.9
F.3 Lighting
F.3.1
F.3.2
F.3.3
F.4 Noise and vibration
F.4.1 General
F.4.2 Sound pressure level
F.4.3 Mechanical vibration
F.4.3.1
F.4.3.2
F.4.3.3
F.5 Energy conservation
Annex G
G.1 Air filtration systems
G.2 Secondary filtration
G.3 Application
G.4 Energy conservation
G.5 Temporary filters
G.6 Packaging and transportation
G.7 Fitting
G.8 Testing
Annex H
H.1 General
H.2 Checklists
H.3 Specification checklist of basic requirements for cleanroom projects
H.4 Relation to clause 4
Bibliography
