EN ISO 14644-4:2001
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
31-10-2001
01-04-2001
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Planning and design
5.1 Planning procedure
5.2 Design
6 Construction and start-up
7 Testing and approval
7.1 General
7.2 Construction approval
7.3 Functional approval
7.4 Operational approval
8 Documentation
8.1 General
8.2 Record of an installation
8.3 Operational instructions
8.4 Instructions for performance monitoring
8.5 Maintenance instructions
8.6 Maintenance record
8.7 Record of operation and maintenance training
Annex A (informative) Control and segregation concepts
Annex B (informative) Classification examples
Annex C (informative) Approval of an installation
Annex D (informative) Layout of an installation
Annex E (informative) Construction and materials
Annex F (informative) Environmental control of cleanrooms
Annex G (informative) Control of air cleanliness
Annex H (informative) Additional specification of
requirements to be agreed upon between
purchaser/user and designer/supplier
Bibliography
Describes requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements.
| Committee |
CEN/TC 243
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DS EN ISO 14644-4 : 2001 | Identical |
| ONORM EN ISO 14644-4 : 2001 | Identical |
| DIN EN ISO 14644-4:2003-06 | Identical |
| SS-EN ISO 14644-4 : 2001 | Identical |
| SN EN ISO 14644-4 : 2001 | Identical |
| NS EN ISO 14644-4 : 1ED 2001 | Identical |
| NBN EN ISO 14644-4 : 2001 | Identical |
| ISO 14644-4:2001 | Identical |
| I.S. EN ISO 14644-4:2001 | Identical |
| PN EN ISO 14644-4 : 2006 | Identical |
| UNI EN ISO 14644-4 : 2004 | Identical |
| BS EN ISO 14644-4:2001 | Identical |
| NEN EN ISO 14644-4 : 2001 | Identical |
| UNE-EN ISO 14644-4:2001 | Identical |
| NF EN ISO 14644-4 : 2001 | Identical |
| I.S. EN 13824:2005 | STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS |
| DIN EN ISO 14698-1 E : 2004 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS |
| 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 14698-1:2004-04 | Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003) |
| 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 |
| PREN 17141 : DRAFT 2017 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| BS EN ISO 14698-1:2003 | Cleanrooms and associated controlled environments. Biocontamination control General principles and methods |
| I.S. EN ISO 14698-1:2003 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS |
| VDI 2083 Blatt 17:2013-06 | Cleanroom technology - Compatibility of materials with the required cleanliness |
| VDI 2083 Blatt 18:2012-01 | Cleanroom technology - Biocontamination control |
| VDI 2083 Blatt 15:2007-04 | Cleanroom technology - Personnel at the clean work place |
| 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 9.1:2006-12 | Clean room technology - Compatibility with required cleanliness and surface cleanliness |
| VDI 2083 Blatt 3:2005-07 | Cleanroom technology - Metrology and test methods |
| EN ISO 14698-1 : 2003 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS |
| 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) |
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
| 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 |
| 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 |
| ISO 9004-1:1994 | Quality management and quality system elements Part 1: Guidelines |
| VDI 2083 Blatt 2:2015-04 | Cleanroom technology - Stipulations regarding the checking and monitoring of continued compliance with specifications |
| ISO 14698-2:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data |
| 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 1822-5:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 5: Determining the efficiency of filter elements |
| ISO 1940-1:2003 | Mechanical vibration Balance quality requirements for rotors in a constant (rigid) state Part 1: Specification and verification of balance tolerances |
| EN 779:2012 | Particulate air filters for general ventilation - Determination of the filtration performance |
| EN 1822-2:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 2: Aerosol production, measuring equipment, particle counting statistics |
| 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 |
| ISO 3746:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane |
| ISO 14004:2016 | Environmental management systems General guidelines on implementation |
| ISO 14644-3:2005 | Cleanrooms and associated controlled environments Part 3: Test methods |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO 10816-1:1995 | Mechanical vibration Evaluation of machine vibration by measurements on non-rotating parts Part 1: General guidelines |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 9001:2015 | Quality management systems — Requirements |
| 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 |
| EN 1822-3:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 3: Testing flat sheet filter media |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| EN 1822-1:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking |
| EN 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 (ISO 14644-2:2015) |
| EN ISO 14644-1:2015 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) |
| EN 1822-4:2009 | High efficiency air filters (EPA, HEPA and ULPA) - Part 4: Determining leakage of filter elements (scan method) |
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