GB/T 25915.3-2024Cleanrooms and associated controlled environments - Part 3: Test methods (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting.

This document is part 3 of GB/T 25915 Cleanrooms and Related Controlled Environments. GB/T 25915 has been published in the following parts.

--- Part 1: Classification of air cleanliness levels according to particle concentration;

--- Part 2: Monitoring of particle concentration in clean room air;

--- Part 3: Detection methods;

--- Part 4: Design, construction and start-up;

--- Part 5: Operation;

--- Part 6: Vocabulary;

--- Part 7: Isolation devices (clean air hoods, glove boxes, isolators, microenvironments);

--- Part 8: Classification of air cleanliness (ACC) by chemical concentration;

--- Part 9: Classification of surface cleanliness levels according to particle concentration;

--- Part 10: Classification of surface cleanliness levels according to chemical concentration;

--- Part 12: Technical requirements for monitoring the concentration of nanoparticles in the air;

--- Part 13: Surface cleaning to meet particle and chemical cleanliness requirements;

--- Part 14: Assessment of equipment suitability according to particle concentration;

--- Part 15: Assessment of the suitability of equipment and materials according to the concentration of gaseous chemicals;

--- Part 16: Improving the energy efficiency of clean rooms and air purification equipment.

This document replaces GB/T 25915.3-2010 "Clean rooms and related controlled environments Part 3: Test methods" and GB/T 25915.3-Compared with 2010, in addition to structural adjustments and editorial changes, the main technical changes are as follows.

a) Chapter 3 Terms and Definitions.

--- Change the term "discrete particle counter" to "light scattering particle counter" (see 3.6.4, 3.6.8 of the 2010 edition);

--- Added "resolution" (see 3.1.5), "sensitivity" (see 3.1.6) and "air volume hood equipped with flow meter" (see 3.6.3);

--- Deleted "large particles", "M descriptor", "U descriptor", "ultrafine particles", "standard leakage transmittance", "average air volume", "non-equal Dynamic sampling, cascade impact sampler, condensation nucleus counter, counting efficiency, differential mobility analyzer, diffusion element "Pseudo-counting", "Volume hood", "Coaxial sampling", "Isokinetic sampling", "Particle size limiter", "Threshold particle size", "Time of flight particle size" Measurement" and "Virtual Impactor" (see 3.2.4, 3.2.5, 3.2.11, 3.2.12, 3.3.10, 3.4.2, 3.6.2, 3.6.3, 3.6.4, 3.6.5, 3.6.6, 3.6.7, 3.6.9, 3.6.10, 3.6.11, 3.6.12, 3.6.13, 3.6.14, 3.6.15, 3.6.16);

b) Changed "Required Test Items" to "General Tests" and updated the specific content (see 4.1.1, 4.1.1 of the 2010 edition);

c) Changed "optional test items" to "supportive tests" and updated the test items (see Table 2, Table 2 of the 2010 edition);

d) Change "airflow detection" to "wind speed and air volume detection", "airflow direction detection and visual inspection" to "airflow direction detection and visual inspection" "Isolation leak detection" is "Enclosure structure tightness detection" (see Table 2, Table 2 of the 2010 edition);

e) The pressure difference detection (see 4.2.1, 4.2.3 of the 2010 edition), wind speed and air volume detection (see 4.2.2, 4.2.2 of the 2010 edition), Airflow direction detection and visualization (see 4.2.3, 4.2.5 of the 2010 edition), self-cleaning detection (see 4.2.4, 4.2.9 of the 2010 edition), temperature Temperature test (see 4.2.5, 4.2.6 of the 2010 edition), humidity test (see 4.2.6, 4.2.6 of the 2010 edition), leakage test of installed filter system Leakage detection (see 4.2.7, 4.2.4 of the 2010 edition), enclosure tightness detection (see 4.2.8, 4.2.10 of the 2010 edition), static Electricity and ionizer testing (see 4.2.9, 4.2.7 of the 2010 edition), particle deposition testing (see 4.2.10, 4.2.8);

f) Deleted the airborne particle count (see 4.2.1 of the 2010 edition);

g) Added isolation detection (see 4.2.11).

This document is equivalent to ISO 14644-3:2019 "Cleanrooms and associated controlled environments Part 3: Test methods".

The following minimal editorial changes were made to this document.

---Test items "air supply speed (unidirectional flow)" and "average wind speed in clean room or clean area" in Table A.1 of ISO 14644-3:2019 "Uniformity (unidirectional flow)" does not correspond to the test procedure reference clauses B.2.2.2 and B.2.3.This document has been adjusted accordingly.

Introduction

GB/T 25915 adopts the ISO 14644 series of national standards, and the settings of each part are consistent with international standards. It is planned to consist of 16 parts.

constitute.

--- Part 1: Classification of air cleanliness levels by particle concentration. The purpose is to distinguish particle pollution concentration.

--- Part 2: Monitoring of particle concentration in clean room air. The purpose is to guide the monitoring of particle contamination to avoid possible contamination risk.

--- Part 3: Detection methods. The purpose is to guide the detection of various pollution and related environmental factors in clean rooms.

--- Part 4: Design, construction and startup. The purpose is to guide the design, construction and startup of clean rooms.

--- Part 5: Operation. The purpose is to guide the operation of the clean room.

--- Part 6: Vocabulary. The purpose is to unify and standardize technical terms.

--- Part 7: Isolation devices (clean hoods, glove boxes, isolators, microenvironments). The purpose is to propose basic this requirement.

--- Part 8: Classification of air cleanliness (ACC) levels by chemical concentration. The purpose is to distinguish the degree of chemical pollution in the air.

--- Part 9: Classification of surface cleanliness levels according to particle concentration. The purpose is to distinguish the degree of surface particle contamination.

--- Part 10: Classification of surface cleanliness levels according to chemical concentration. The purpose is to distinguish the degree of chemical contamination on the surface.

--- Part 12: Technical requirements for monitoring the concentration of nanoparticles in the air. The purpose is to propose the detection of nano-scale particle pollution Require.

--- Part 13: Surface cleaning to achieve particle and chemical cleanliness requirements. The purpose is to provide cleaning requirements for surfaces within clean rooms to Avoid possible risks of particle and chemical contamination.

--- Part 14: Assessment of equipment suitability by particle concentration. The purpose is to assess the possible particle contamination that may be generated in the clean room by the relevant equipment.

Tests to determine the suitability of the equipment.

--- Part 15: Assessment of the suitability of equipment and materials according to the concentration of gaseous chemicals. The purpose is to assess the suitability of equipment and materials by assessing...

Tests that generate gaseous chemical contamination in clean rooms to determine the suitability of equipment and materials.

--- Part 16: Improving the energy efficiency of clean rooms and air purification equipment. The purpose is to save energy consumption in clean room operation.

--- Part 17: Application of particle deposition rate. The purpose is to determine the deposition rate of particles into the clean room by measuring the particle deposition rate of the clean room.

Acceptable risk to vulnerable surfaces in the room.

Cleanrooms and related controlled environments keep contaminants at appropriate levels to complete contamination-sensitive work.

Products and processes in industries such as pharmaceuticals, medical devices, food, and healthcare benefit from the control of air pollution.

This document does not contain the testing procedures for all clean room parameters. GB/T 25915.1 provides the classification of air cleanliness by particles, etc.

GB/T 25915.12 provides the technical requirements for monitoring the concentration of nanoparticles in the air.

Cleanrooms and clean areas for specific processes and the testing procedures and instruments used for related parameters are included in other documents prepared by ISO/TC209 Discussion [e.g. microbial control and detection procedures (GB/T 25916 series), clean room functional testing (GB/T 25915.4), and isolation Device testing (GB/T 25915.7)]. In addition, other applicable standards can also be considered in the clean room testing activities.

The level of air cleanliness can be classified by GB/T 25915.8 (classification of air cleanliness by chemical concentration), GB/T 25915.9 (classification by particle concentration).

The surface cleanliness level is determined by GB/T 25915.10 (surface cleanliness level according to chemical concentration).

Cleanrooms and related controlled environments Part 3: Detection methods

1 Scope

This document specifies test methods to support cleanroom and clean zone operations to meet air cleanliness levels, other cleanliness attributes and related control requirements.

Control conditions.

Performance testing is performed on cleanrooms with unidirectional and non-unidirectional flow in any of the three occupied states. empty, static and dynamic.

Clean area.

This document recommends test instruments and test procedures for determining performance parameters. Some test methods are limited to the type of clean room or clean area.

For this reason, this document recommends several alternative approaches.

In order to meet the requirements of different users, this document recommends several different methods and instruments for certain test items.

Other alternative methods not described in this document may be used by mutual agreement. Alternative methods do not necessarily give the same measurement results.

This document is not intended for use in measuring products or processes within cleanrooms or isolators.

Note. This document does not mention safety precautions related to its use (such as when hazardous materials, operations, equipment are involved). Users of this document are responsible for using Establish appropriate safety and health measures before use and determine the applicability of regulatory restrictions.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to this document.

ISO 14644-1 Cleanrooms and related controlled environments Part 1: Classification of air cleanliness by particle concentration tion) Note. GB/T 25915.1-2021 Clean rooms and related controlled environments Part 1: Classification of air cleanliness levels by particle concentration (ISO 14644-1.

2015,MOD)

3 Terms and definitions

The following terms and definitions apply to this document.