13.040.35 清洁室(无菌室)及相关受控环境 标准查询与下载



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This part of ISO 14644 covers the classification of air cleanli-ness in cleanrooms and associated controlled environments exclusively in terms of concentration of airborne particles. Only particle populations having cumulative distributions based on threshold (lower limit) sizes ranging from 0,1 μm to 5 μm are considered for classification purposes. This part of ISO 14644 does not provide for classification of particle populations that are outside of the specified particle size range, 0,1 μm to 5 μm. Concentrations of ultrafine particles (particles smaller than 0,1 μm) and macroparticles (particles larger than 5 μm) may be used to quantify these populations in terms of U descriptors and M descriptors, respectively. This part of ISO 14644 cannot be used to characterize the physical, chemical, radiological, or viable nature of airborne particles. NOTE The actual distribution of particle concentrations within incre-mental size ranges normally is not predictable and typically is variable over time.

Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

ICS
13.040.35
CCS
C04
发布
1999-05
实施

High-Purity/Ultra-High-Purity (HP-/UHP-) media (chemicals and gases) are being used more and more for many production purposes. The aim is to maintain the level of cleanliness between the point of supply (P.O.S.) and the point of entry (P.O.E.) or, respectively, to accept a reduction in purity only in certain defined areas where it is permissible. The purpose of this Guideline is to summarize knowledge regarding the design, construction, operation and monitoring of HP-/UHP-media supply systems. Cleanliness refers to residual contaminants such as particles, cations, anions, TOC and other specific parameters (foreign gases, humidity etc.). There is no information provided concerning cleanliness requirement conditions as these shall be determined by the respective user according to the intended utilization.

Cleanroom technology - High-Purity/Ultra-High-Purity (HP-/UHP-)media supply systems

ICS
13.040.35
CCS
发布
1998-02
实施

Cleanroom technology. Design, construction and operation of cleanrooms and clean air devices

ICS
13.040.35
CCS
C72
发布
1996-12-15
实施
1996-12-15

This part of ISO 14644 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational. The test methods recommend test apparatus and test procedures for determining performance parameters. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested. For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations. Alternative methods not included in this part of ISO 14644 may be used if based on agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements. This part of ISO 14644 is not applicable to the measurement of products or of processes in cleanrooms or separative devices.

Cleanrooms and associated controlled environments - Part 3: Test methods ISO 14644-3: 2005

ICS
13.040.35
CCS
C47
发布
实施
0000-00-00

N/A

Cleanrooms and associated controlled environments - Part 18: Assessment of suitability of consumables (ISO/DIS 14644-18:2022)

ICS
13.040.35
CCS
发布
实施



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