ISO 14644-3:2019(ES)

Foreword

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This document was prepared by ISO/TC 209, Cleanrooms and associated controlled environments.

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This second edition of ISO 14644-3 cancels and replaces the first edition (ISO 14644-3:2005), which has been technically revised. The main changes compared to the previous edition are as follows:

• Clause B.7 has been simplified and corrected to address concerns over its complexity and noted errors;

• guidance concerning classification of air cleanliness by airborne particle concentration has been moved to 14644-1[1]

• the text of the whole document has been revised or clarified to aid in application.

A list of all parts in the ISO 14644 series can be found on the ISO website.

This corrected version of ISO 14644-3:2019 incorporates the following corrections:

• cross-references have been corrected in Table A.1, B.4.4, C.1, C.4.2 and C.4.3;

• the wording has been changed in B.2.1 a), Table B.2;

• old Figure B.2 has been removed.

Introduction

Cleanrooms and associated controlled environments provide control of contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include those in such industries as aerospace, microelectronics, pharmaceuticals, medical devices, healthcare and food.

This document sets out appropriate test methods for measuring the performance of a cleanroom, a clean zone or an associated controlled environment, including separative devices and controlled zones, together with all associated structures, air treatment systems, services and utilities.

NOTE Not all cleanroom parameter test procedures are shown in this document. The procedure and apparatus for the test carried out for the air cleanliness classes by particle concentration and for macroparticles are provided in ISO 14644-1,[1] and specifications for monitoring air cleanliness by nanoscale particle concentrations are provided in ISO 14644-12.[8] The procedures and apparatus to characterize other parameters, of concern in cleanrooms and clean zones used for specific products or processes, are discussed elsewhere in other documents prepared by ISO/TC 209 [for example, procedures for control and measurement of viable materials (ISO 14698 series), testing cleanroom functionality (ISO 14644-4[3]), and testing of separative devices (ISO 14644-7[4])]. In addition, other standards can be considered to be applicable. Other cleanliness attribute levels can be determined using ISO 14644-8[5] (levels of air cleanliness by chemicals), ISO 14644-9[6] (levels of surface cleanliness by particle concentration) and ISO 14644-10[7] (levels of surface cleanliness by chemical concentration).