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ISO 14644-3:2019

Current
Current

The latest, up-to-date edition.

Cleanrooms and associated controlled environments Part 3: Test methods
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

08-30-2019

This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions.

Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest and operational.

The test methods, recommended test apparatus and test procedures for determining performance parameters are provided. 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 document can be used by agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements.

This document is not applicable to the measurement of products or of processes in cleanrooms, clean zones or separative devices.

NOTE This document does not purport to address safety considerations associated with its use (for example, when using hazardous materials, operations and equipment). It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

DocumentType
Standard
Pages
53
PublisherName
International Organization for Standardization
Status
Current
Supersedes

AAMI TIR52:2014(R2022) Environmental monitoring for terminally sterilized healthcare products

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