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EN ISO 14644-5:2004

Current
Current

The latest, up-to-date edition.

Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
Published date

15-08-2004

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Specification of requirements
Annex A (informative) Operational systems
Annex B (informative) Cleanroom clothing
Annex C (informative) Personnel
Annex D (informative) Stationary equipment
Annex E (informative) Materials and portable equipment
Annex F (informative) Cleanroom cleaning
Bibliography

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.

Committee
CEN/TC 243
DevelopmentNote
Supersedes ENV 1631. (03/2005)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
BS EN 13824:2004 Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
DIN EN ISO 13408-1:2015-12 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
VDI 4066 Blatt 4:2016-04 Hygiene requirements for the production and filling of dairy products without recontamination
VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
VDI 4066 Blatt 1:2013-05 Hygienic requirements for the production and aseptically filling of beverage products - Principles and design criteria
VDI 2083 Blatt 8.1:2014-10 Cleanroom technology - Air cleanliness chemical concentration (ACC)
VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
VDI 2083 Blatt 13.2:2009-01 Cleanroom technology - Quality, production and distribution of ultrapure water - Microelectronics and other technical applications
VDI 2083 Blatt 13.1:2009-01 Cleanroom technology - Quality, production and distribution of ultrapure water - Fundamentals
VDI 2083 Blatt 4.1:2006-10 Cleanroom technology - Planning, construction and start-up of cleanrooms
VDI 2083 Blatt 5.1:2007-09 Cleanroom technology - Cleanroom operation
PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
EN 13824 : 2004 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
I.S. EN ISO 13408-1:2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
17/30329441 DC : 0 BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
DIN EN 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS

IEC 61025:2006 Fault tree analysis (FTA)
IEST RP CC023.1 : 1993 MICROORGANISMS IN CLEANROOMS
IEST RP CC004.2 : 1992 EVALUATING WIPING MATERIALS USED IN CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS
ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ISO 9237:1995 Textiles — Determination of the permeability of fabrics to air
ISO 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
EN 1149-1:2006 Protective clothing - Electrostatic properties - Part 1: Test method for measurement of surface resistivity
IEST RP CC020.2 : 2002 SUBSTRATES AND FORMS FOR DOCUMENTATION IN CLEANROOMS
AS 2013.2-1989 Cleanroom garments - Processing and use
BS 7209:1990 Specification for water vapour permeable apparel fabrics
VDI 2083 Blatt 4:1996-02 Cleanroom technology - Surface cleanliness
ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
AS 2013.1-1989 Cleanroom garments - Product requirements
ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
IEST RP CC022.1 : 1992 ELECTROSTATIC CHARGE IN CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS
IEST STD CC1246 : 2013 PRODUCT CLEANLINESS LEVELS - APPLICATIONS, REQUIREMENTS, AND DETERMINATION
ISO 11092:2014 Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test)
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 7730:2005 Ergonomics of the thermal environment — Analytical determination and interpretation of thermal comfort using calculation of the PMV and PPD indices and local thermal comfort criteria
ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
VDI 2083 Blatt 6:1996-11 Cleanroom technology - Personnel at the clean work place
IEST RP CC003.3 : 2003 ERRATA 2008 GARMENTS SYSTEMS CONSIDERATIONS FOR CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS
IEST RP CC026.1 : 1995 CLEANROOM OPERATIONS
ASTM D 737 : 2004 Test Method for Air Permeability of Textile Fabrics

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