Abstract

This document specifies requirements for the establishment of an operations control programme (OCP) to ensure efficient cleanroom operation within specified cleanliness levels. The OCP includes management of personnel, entry and exit of personnel and materials, cleaning, maintenance and monitoring. This document specifies operational requirements that relate to: — providing a system that specifies policies and operational procedures for maintaining cleanliness levels; — training of personnel; — transferring, installing and maintaining stationary equipment; — transferring material and portable equipment into and out of the cleanroom; — maintaining a personnel management programme that includes a gowning programme; — maintaining a cleaning programme that addresses special cleaning; — maintaining a cleanroom maintenance programme; — establishing an appropriate monitoring programme. This document gives additional information in annexes for: — personnel management; — gowning; — training; — cleaning. This document does not specifically address biocontamination control. For details on this topic, see normative references ISO 14698. This document does not apply to the following topics: — aspects of health and safety management that have no direct bearing on contamination control; — specific requirements for individual industries; — specific requirements for equipment and materials used or associated with processes and products; — design details of equipment; — cleaning agent compatibility with cleanroom materials.

Begin

2021-09-13

WI

00243041

Planned document number

DIN EN ISO 14644-5

Project number

04112099

Responsible national committee

NA 041-02-21 AA - Cleanroom technology (Mirror committee CEN/TC 243 and ISO/TC 209)  

Responsible european committee

CEN/TC 243 - Cleanroom technology  

Responsible international committee

ISO/TC 209/WG 5 - Operations  

draft standard

Cleanrooms and associated controlled environments - Part 5: Operations (ISO/DIS 14644-5:2024); German and English version prEN ISO 14644-5:2024
2024-07
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previous edition(s)

Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004); German version EN ISO 14644-5:2004
2005-03

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