GB/T 25915.2-2021 English PDF (GB/T25915.2-2021)

GB/T 25915.2-2021: Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
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GB/T 25915.2-2021/ISO 14644-2:2015
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.040.35
CCS C 70
GB/T 25915.2-2021 / ISO 14644-2:2015
Replacing GB/T 25915.2-2010
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, IDT)
ISSUED ON: AUGUST 20, 2021
IMPLEMENTED ON: MARCH 01, 2022
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 8
2 Normative references ... 8
3 Terms and definitions ... 8
4 Creating, implementing and maintaining a monitoring plan ... 9
5 Periodic classification of air cleanliness by particle concentration ... 12
Annex A (Informative) Matters to consider when developing a monitoring plan ... 13
Annex B (Informative) Considerations for setting alert and action levels ... 17
Bibliography ... 23
Foreword
This document was drafted in accordance with the rules given in GB/T 1.1-2020,
Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents.
This document is Part 2 of GB/T 25915, Cleanrooms and associated controlled
environments. The following parts have been issued for GB/T 25915:
-- Part 1: Classification of air cleanliness by particle concentration;
-- Part 2: Monitoring to provide evidence of cleanroom performance related to
air cleanliness by particle concentration;
-- Part 3: Test methods;
-- Part 4: Design, construction and start-up;
-- Part 5: Operations;
-- Part 6: Vocabulary;
-- Part 7: Separative devices (clean air hoods, gloveboxes, isolators and
minienvironments);
-- Part 8: Classification of air cleanliness by chemical concentration (ACC);
-- Part 9: Classification of surface cleanliness by particle concentration;
-- Part 10: Classification of surface cleanliness by chemical concentration;
-- Part 12: Specifications for monitoring of air cleanliness by nanoscale particle
concentration.
This document replaces GB/T 25915.2-2010, Cleanrooms and associated controlled
environments - Part 2: Specifications for testing and monitoring to prove continued
compliance with GB/T 25915.1. Compared with GB/T 25915.2-2010, the main
technical changes are as follows:
a) Modify the scope (see Chapter 1; Chapter 1 of the 2010 edition);
b) In terms and definitions, keep only the original two terms, test and monitoring;
delete the other six terms (see Chapter 3 of the 2010 edition); add two terms,
action level and alert level (see 3.3 and 3.4);
c) Change “Demonstration of maintaining the requirements” to “Creating,
implementing and maintaining a monitoring plan” (see Chapter 4; Chapter 4
of the 2010 edition);
Cleanrooms and associated controlled environments - Part
2: Monitoring to provide evidence of cleanroom
performance related to air cleanliness by particle
concentration
1 Scope
This document specifies minimum requirements for a monitoring plan. This monitoring
plan is for cleanroom or clean zone performance related to air cleanliness by particle
concentration, based upon parameters that measure or affect airborne particle
concentration.
This document applies to the monitoring of particle concentration of particle-size range
0.1 μm ~ 5 μm.
This document does not address condition monitoring of aspects such as vibration or
general maintenance of the engineering systems. Concentrations of ultrafine particles
(particles smaller than 0.1 μm) will be addressed in a separate standard.
2 Normative references
The following documents are referred to in the text in such a way that some or all of
their content constitutes requirements 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 25915.1-2021, Cleanrooms and associated controlled environments - Part
1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015,
MOD)
Note: There is no technical difference between the content cited in GB/T
25915.1-2021 and the content cited in ISO 14644-1:2015.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 25915.1-
2021 and the following apply:
3.1
GB/T 25915.2-2021/ISO 14644-2:2015
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.040.35
CCS C 70
GB/T 25915.2-2021 / ISO 14644-2:2015
Replacing GB/T 25915.2-2010
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, IDT)
ISSUED ON: AUGUST 20, 2021
IMPLEMENTED ON: MARCH 01, 2022
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 8
2 Normative references ... 8
3 Terms and definitions ... 8
4 Creating, implementing and maintaining a monitoring plan ... 9
5 Periodic classification of air cleanliness by particle concentration ... 12
Annex A (Informative) Matters to consider when developing a monitoring plan ... 13
Annex B (Informative) Considerations for setting alert and action levels ... 17
Bibliography ... 23
Foreword
This document was drafted in accordance with the rules given in GB/T 1.1-2020,
Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents.
This document is Part 2 of GB/T 25915, Cleanrooms and associated controlled
environments. The following parts have been issued for GB/T 25915:
-- Part 1: Classification of air cleanliness by particle concentration;
-- Part 2: Monitoring to provide evidence of cleanroom performance related to
air cleanliness by particle concentration;
-- Part 3: Test methods;
-- Part 4: Design, construction and start-up;
-- Part 5: Operations;
-- Part 6: Vocabulary;
-- Part 7: Separative devices (clean air hoods, gloveboxes, isolators and
minienvironments);
-- Part 8: Classification of air cleanliness by chemical concentration (ACC);
-- Part 9: Classification of surface cleanliness by particle concentration;
-- Part 10: Classification of surface cleanliness by chemical concentration;
-- Part 12: Specifications for monitoring of air cleanliness by nanoscale particle
concentration.
This document replaces GB/T 25915.2-2010, Cleanrooms and associated controlled
environments - Part 2: Specifications for testing and monitoring to prove continued
compliance with GB/T 25915.1. Compared with GB/T 25915.2-2010, the main
technical changes are as follows:
a) Modify the scope (see Chapter 1; Chapter 1 of the 2010 edition);
b) In terms and definitions, keep only the original two terms, test and monitoring;
delete the other six terms (see Chapter 3 of the 2010 edition); add two terms,
action level and alert level (see 3.3 and 3.4);
c) Change “Demonstration of maintaining the requirements” to “Creating,
implementing and maintaining a monitoring plan” (see Chapter 4; Chapter 4
of the 2010 edition);
Cleanrooms and associated controlled environments - Part
2: Monitoring to provide evidence of cleanroom
performance related to air cleanliness by particle
concentration
1 Scope
This document specifies minimum requirements for a monitoring plan. This monitoring
plan is for cleanroom or clean zone performance related to air cleanliness by particle
concentration, based upon parameters that measure or affect airborne particle
concentration.
This document applies to the monitoring of particle concentration of particle-size range
0.1 μm ~ 5 μm.
This document does not address condition monitoring of aspects such as vibration or
general maintenance of the engineering systems. Concentrations of ultrafine particles
(particles smaller than 0.1 μm) will be addressed in a separate standard.
2 Normative references
The following documents are referred to in the text in such a way that some or all of
their content constitutes requirements 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 25915.1-2021, Cleanrooms and associated controlled environments - Part
1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015,
MOD)
Note: There is no technical difference between the content cited in GB/T
25915.1-2021 and the content cited in ISO 14644-1:2015.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 25915.1-
2021 and the following apply:
3.1