GB/T 25915.2-2021Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (English PDF)
洁净室及相关受控环境 第2部分:洁净室空气粒子浓度的监测
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
August 20, 2021
Implementation date
March 1, 2022
Scope
GB/T 25915.2-2021 is the English-translated version of 洁净室及相关受控环境 第2部分:洁净室空气粒子浓度的监测.
GB/T 25915.2-2021 — 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
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Document preview — GB/T 25915.2-2021
National Standard of the People's Republic of China
Issued by: SAMR; SAC
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
......
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — all pages — is available in the English PDF.
Referenced standards
Normative references
ISO 14644
Cited by
- GB/T 33556.1-2025Application specification for hospital cleanrooms and associated controlled environments — Part 1: General guidelines
- GB/T 25915.1-2021Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
- GB/T 33556.1-2017Application Specification for Hospital Cleanrooms and Associated Controlled Environment - Part 1: General Guidelines
- YY/T 1295-2015Biological evaluation of medical devices—Nanomaterial:Endotoxin test
- GB/T 25915.5-2010Cleanrooms and associated controlled environments -- Part 5: Operations
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Related Standards
GB/T 25915.1-2021 — Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
GB/T 25915.3-2024 — Cleanrooms and associated controlled environments - Part 3: Test methods
GB/T 25915.4-2010 — Cleanrooms and associated controlled environments -- Part 4: Design, construction and start-up
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