EN ISO 14644-5:2004
Current
The latest, up-to-date edition.
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
08-15-2004
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 |
| Standards | Relationship |
| NF EN ISO 14644-5 : 2004 | Identical |
| BS EN ISO 14644-5:2004 | Identical |
| NEN EN ISO 14644-5 : 2004 | Identical |
| UNE-EN ISO 14644-5:2005 | Identical |
| I.S. EN ISO 14644-5:2004 | Identical |
| PN EN ISO 14644-5 : 2005 | Identical |
| DIN EN ISO 14644-5:2005-03 | Identical |
| NS EN ISO 14644-5 : 1ED 2004 | Identical |
| SN EN ISO 14644-5 : 2005 | Identical |
| ISO 14644-5:2004 | Identical |
| NBN EN ISO 14644-5 : 2004 | Identical |
| UNI EN ISO 14644-5 : 2005 | Identical |
| SS-EN ISO 14644-5 : 2004 | Identical |
| 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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