GB/T 25915.5-2010 Cleanrooms and associated controlled environments - Part 5: Operations
1 Scope
This part of GB/T 25915 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, this document is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part, but reference shall be made to GB/T 25915.2 and GB/T 25915.3 for monitoring particles and GB/T 25916.1 and GB/T 25916.2 for monitoring micro-organisms.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 25915.1-2010 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999, IDT)
GB/T 25915.2-2010 Cleanrooms and associated controlled environments - Specifications for testing and monitoring to prove continued compliance with GB/T 25915.1 (ISO 14644-2:2000, IDT)
GB/T 25915.3-2010 Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005, IDT)
GB/T 25915.4-2010 Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001, IDT)
GB/T 25915.6-2010 Cleanrooms and associated controlled environments - Part 6: Vocabulary (ISO 14644-6:2007, IDT)
GB/T 25916.1-2010 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003, IDT)
GB/T 25916.2-2010 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 General concepts
3.1.1
biocleanroom
cleanroom used for products and processes that are sensitive to microbiological contamination
3.1.2
changing room
room where people entering or leaving a cleanroom put on or take off cleanroom clothing
[GB/T 25915.4-2010, 3.1]
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements
Annex A (Informative) Operational systems
Annex B (Informative) Cleanroom clothing
Annex C (Informative) Personnel
Annex D (Informative) Stationary equipment
Annex E (Informative) Materials and portable equipment
Annex F (Informative) Cleanroom cleaning
Bibliography
GB/T 25915.5-2010 Cleanrooms and associated controlled environments - Part 5: Operations
1 Scope
This part of GB/T 25915 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, this document is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part, but reference shall be made to GB/T 25915.2 and GB/T 25915.3 for monitoring particles and GB/T 25916.1 and GB/T 25916.2 for monitoring micro-organisms.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 25915.1-2010 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999, IDT)
GB/T 25915.2-2010 Cleanrooms and associated controlled environments - Specifications for testing and monitoring to prove continued compliance with GB/T 25915.1 (ISO 14644-2:2000, IDT)
GB/T 25915.3-2010 Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005, IDT)
GB/T 25915.4-2010 Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001, IDT)
GB/T 25915.6-2010 Cleanrooms and associated controlled environments - Part 6: Vocabulary (ISO 14644-6:2007, IDT)
GB/T 25916.1-2010 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003, IDT)
GB/T 25916.2-2010 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 General concepts
3.1.1
biocleanroom
cleanroom used for products and processes that are sensitive to microbiological contamination
3.1.2
changing room
room where people entering or leaving a cleanroom put on or take off cleanroom clothing
[GB/T 25915.4-2010, 3.1]
Contents of GB/T 25915.5-2010
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements
Annex A (Informative) Operational systems
Annex B (Informative) Cleanroom clothing
Annex C (Informative) Personnel
Annex D (Informative) Stationary equipment
Annex E (Informative) Materials and portable equipment
Annex F (Informative) Cleanroom cleaning
Bibliography
