ISO 14698-1:2003
Current
Current
The latest, up-to-date edition.
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
€149.00
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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 |
Current
|
| Standards | Relationship |
| ONORM EN ISO 14698-1 : 2004 | Identical |
| 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 |
| ONORM EN ISO 14698-2 : 2010 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA |
| 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 |
| 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 |
| ONORM EN ISO 13408-1 : 2015 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
| 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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