EN ISO 14644-4:2001
Withdrawn
Withdrawn
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
Published date
04-01-2001
Publisher
Withdrawn date
10-31-2001
Sorry this product is not available in your region.
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
| Committee |
CEN/TC 243
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DS EN ISO 14644-4 : 2001 | Identical |
| DIN EN ISO 14644-4:2003-06 | Identical |
| SS-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 |
| BS EN ISO 14644-4:2001 | Identical |
| NEN EN ISO 14644-4 : 2001 | Identical |
| NF EN ISO 14644-4 : 2001 | Identical |
| UNE-EN ISO 14644-4:2001 | 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 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 (ISO 14698-1:2003) |
| 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 |
| I.S. EN 17141:2020 | Cleanrooms and associated controlled environments - Biocontamination control |
| 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) |
Summarise
Sorry this product is not available in your region.