ISO 14698-1:2003
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods
Available format(s)
Hardcopy , PDF
Language(s)
English, French
Published date
17-09-2003
Withdrawn date
16-03-2026
€65.00
Excluding VAT
ISO 14698:2003 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used for information.
| Committee |
ISO/TC 209
|
| DevelopmentNote |
Supersedes ISO/DIS 14698-1 (09/2003)
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| Standards | Relationship |
| EN ISO 14698-2:2003 | Identical |
| NF EN ISO 14698-1 : 2004 | Identical |
| GOST ISO 14698-1 : 2005 | Identical |
| NBN EN ISO 14698-1 : 2004 | Identical |
| NEN EN ISO 14698-1 : 2003 | Identical |
| I.S. EN ISO 14698-1:2003 | Identical |
| PN EN ISO 14698-1 : 2004 | Identical |
| SS-EN ISO 14698-1 : 2003 | Identical |
| BS EN ISO 14698-1:2003 | Identical |
| EN ISO 14698-1:2003 | Identical |
| DIN EN ISO 14698-1:2004-04 | Identical |
| NS EN ISO 14698-1 : 1ED 2003 | Identical |
| UNE-EN ISO 14698-1:2004 | Identical |
| JIS B 9918-1:2008 | Identical |
| BS EN 16602-70-55:2015 | Space product assurance. Microbiological examination of flight hardware and cleanrooms |
| I.S. EN 13824:2005 | STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS |
| AAMI ISO 13408-1 : 2008 : R2011 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN 16602-70-58:2015 | SPACE PRODUCT ASSURANCE - BIOBURDEN CONTROL OF CLEANROOMS |
| AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| BS EN ISO 14644-6:2007 | Cleanrooms and associated controlled environments Vocabulary |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| BS EN 13824:2004 | Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements |
| BS EN 16602-70-58:2015 | Space product assurance. Bioburden control of cleanrooms |
| AAMI TIR52 : 2014(R2017) | ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
| BS ISO 15378 : 2006 AMD 17315 | PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| 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) |
| AAMI ST67 : 2011 | STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE' |
| BS EN ISO 13408-1:2015 | Aseptic processing of health care products General requirements |
| I.S. EN 16602-70-55:2015 | SPACE PRODUCT ASSURANCE - MICROBIOLOGICAL EXAMINATION OF FLIGHT HARDWARE AND CLEANROOMS |
| GOST ISO 14698-2 : 2005 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA |
| ISO 14644-6:2007 | Cleanrooms and associated controlled environments — Part 6: Vocabulary |
| BS EN ISO 14644-4:2001 | Cleanrooms and associated controlled environments Design, construction and start-up |
| I.S. EN 14065:2016 | TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM |
| I.S. EN ISO 14644-6:2007 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY |
| VDI 2083 Blatt 18:2012-01 | Cleanroom technology - Biocontamination control |
| VDI 2083 Blatt 15:2007-04 | Cleanroom technology - Personnel at the clean work place |
| NASA-STD-8719.27:2022 | IMPLEMENTING PLANETARY PROTECTION REQUIREMENTS FOR SPACE FLIGHT |
| VDI 4066 Blatt 1:2013-05 | Hygienic requirements for the production and aseptically filling of beverage products - Principles and design criteria |
| VDI 6300 Blatt 1:2016-05 | Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities |
| VDI 2083 Blatt 3:2005-07 | Cleanroom technology - Metrology and test methods |
| VDI 2083 Blatt 5.1:2007-09 | Cleanroom technology - Cleanroom operation |
| BS ISO 15388:2012 | Space systems. Contamination and cleanliness control |
| 01/121101 DC : DRAFT MAR 2001 | BS EN ISO 14644-7 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE ENCLOSURES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS, MINI-ENVIRONMENTS) |
| 07/30090385 DC : 0 | ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| ISO 15378:2017 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| EN ISO 15378:2017 | Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017) |
| AAMI ST15883-1 : 2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| ANSI/AAMI ST15883-1:2009(R2014) &A1:2014&A2:2012 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| ISO 15388:2012 | Space systems — Contamination and cleanliness control |
| DIN EN ISO 14644-5:2005-03 | Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004) |
| BS EN ISO 14698-2:2003 | Cleanrooms and associated controlled environments. Biocontamination control Evaluation and interpretation of biocontamination data |
| ISO 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
| ISO 15883-1:2006 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests |
| I.S. EN ISO 14698-2:2003 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA |
| I.S. EN ISO 15883-1:2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006) |
| EN 16602-70-55:2015 | Space product assurance - Microbiological examination of flight hardware and cleanrooms |
| 05/30142385 DC : DRAFT NOV 2005 | ISO 14644-6 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY |
| IEC/IEEE 62659:2015 | Nanomanufacturing - Large scale manufacturing for nanoelectronics |
| BS EN ISO 15378:2017 | Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| 12/30252545 DC : 0 | BS ISO 15883-1:2006/AMD - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| 10/30234886 DC : 0 | BS ISO 15388 - SPACE SYSTEMS - CONTAMINATION AND CLEANLINESS CONTROL |
| 00/705381 DC : DRAFT FEB 2000 | ISO/CD 15388 - SPACE SYSTEMS - CONTAMINATION AND CLEANLINESS CONTROL |
| AAMI ST67 : 2011 : R2017 | STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE' |
| AAMI TIR52 : 2014 | ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
| AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| AAMI ISO 13408-1:2008 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| PREN 17141 : DRAFT 2017 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| I.S. EN ISO 15378:2017 | PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017) |
| BS EN ISO 14644-5:2004 | Cleanrooms and associated controlled environments Operations |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| BS EN ISO 14644-7:2004 | Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| BS EN 14065:2016 | Textiles. Laundry processed textiles. Biocontamination control system |
| BS EN ISO 15883-1 : 2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006) |
| EN ISO 14644-5:2004 | Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004) |
| EN ISO 13408-1:2015 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| EN ISO 14644-7:2004 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004) |
| EN 16602-70-58:2015 | Space product assurance - Bioburden control of cleanrooms |
| EN ISO 14644-6:2007 | Cleanrooms and associated controlled environments - Part 6: Vocabulary (ISO 14644-6:2007) |
| EN 14065:2016 | Textiles - Laundry processed textiles - Biocontamination control system |
| EN ISO 14644-4:2001 | Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001) |
| EN 13824:2004 | Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements |
| 14/30287226 DC : 0 | BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| 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) |
| 04/30079743 DC : DRAFT APR 2004 | ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000 WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| 17/30329441 DC : 0 | BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL |
| DIN EN ISO 15883-1:2014-10 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014) (includes Amendment A1:2014) |
| DIN EN 14065:2016-08 | TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM |
| ISO 14698-2:2003 | Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data |
| BS EN 14583:2004 | Workplace atmospheres. Volumetric bioaerosol sampling devices. Requirements and test methods |
| DIN EN ISO 14698-2:2004-02 | Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003) |
| DIN EN 14583:2004-12 | Workplace atmospheres - Volumetric bioaerosol sampling devices - Requirements and test methods |
| DIN EN 13824:2005-02 | STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS |
| I.S. EN 14583:2004 | WORKPLACE ATMOSPHERES - VOLUMETRIC BIOAEROSOL SAMPLING DEVICES - REQUIREMENTS AND TEST METHODS |
| EN 14583:2004 | Workplace atmospheres - Volumetric bioaerosol sampling devices - Requirements and test methods |
| DIN EN ISO 14644-7:2005-01 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004 |
| NBR ISO 15388 : 2016 | SPACE SYSTEMS - CONTAMINATION AND CLEANLINESS CONTROL |
| I.S. EN ISO 15883-1:2009/A1:2014 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1:2014) |
| ANSI/AAMI ST15883-1:2009(R2023) | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests |
| UNE-EN ISO 15378:2016 | Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015) |
| I.S. EN ISO 14644-7:2004 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE DEVICES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS AND MINI-ENVIRONMENTS) |
| UNE-EN 14065:2017 | Textiles - Laundry processed textiles - Biocontamination control system |
| UNE-EN ISO 15883-1:2009 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) |
| UNE 171340:2012 | Validation and evaluation of controlled environment rooms in hospitals |
| I.S. EN ISO 14644-5:2004 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 5: OPERATIONS |
| IEC 61025:2006 | Fault tree analysis (FTA) |
| EN ISO 14644-4:2001 | Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001) |
| ISO 15161:2001 | Guidelines on the application of ISO 9001:2000 for the food and drink industry |
| ISO 7218:2007 | Microbiology of food and animal feeding stuffs — General requirements and guidance for microbiological examinations |
| 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/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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