NF EN ISO 14644-5

NF EN ISO 14644-5

December 2004
Standard Cancelled

Cleanrooms and associated controlled environments - Part 5 : operations

ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2004

Number of pages

57 p.

Reference

NF EN ISO 14644-5

ICS Codes

13.040.35   Cleanrooms and associated controlled environments

Classification index

X44-105

Print number

1 - 23/12/2004

International kinship

ISO 14644-5:2004

European kinship

EN ISO 14644-5:2004
Sumary
Cleanrooms and associated controlled environments - Part 5 : operations

ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

Standard replaced by (1)
NF EN ISO 14644-5
June 2025
Standard Current
Cleanrooms and associated controlled environments - Part 5 : Operations

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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Spécification des exigences
    3
  • Annexe A (informative) Systèmes opérationnels
    7
  • Annexe B (informative) Tenues de salle propre
    14
  • Annexe C (informative) Personnel
    20
  • Annexe D (informative) Matériel fixe
    24
  • Annexe E (informative) Matières et matériel portatif
    29
  • Annexe F (informative) Nettoyage de la salle propre
    37
  • Bibliographie
    48
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