SN EN ISO 14644-5:2025
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2025)
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 ISO 14698-1 and ISO 14698-2. 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.
- Originator
- INB
- Published
- 2025-06-01
- ICS
- 13.040.35
SN EN ISO 14644-5:2025
Reinräume und zugehörige Reinraumbereiche - Teil 5: Betrieb (ISO 14644-5:2025)
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2025)
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 ISO 14698-1 and ISO 14698-2. 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.
Content pages for this standard
guide
Overview of SN EN ISO 14644-5:2025 - Cleanrooms Operations
Explore SN EN ISO 14644-5:2025, focusing on operations in cleanrooms and controlled environments, outlining key requirements and implementation strategies.
Understanding the ISO 14644-5:2025 Certification Process
Learn about the ISO 14644-5:2025 certification process, requirements, and benefits for cleanroom management.