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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 , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

17-09-2003

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.

DevelopmentNote
Supersedes ISO/DIS 14698-1 (09/2003)
DocumentType
Standard
Pages
32
PublisherName
International Organization for Standardization
Status
Current

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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 16602-70-58:2015 Space product assurance - Bioburden control of cleanrooms
EN ISO 14644-6:2007 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY
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)
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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)
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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)
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
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)
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

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
EN ISO 14698-2:2003/AC:2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
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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