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EN ISO 14698-1:2003

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)

Superseded date

23-07-2013

Superseded by

EN 17141:2020

Published date

01-09-2003

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles of biocontamination control
5 Establishing the Formal System
6 Expression, interpretation and reporting of results
7 Verification of the Formal System
8 Training
9 Documentation
Annex A (informative) Guidance on determining airborne
                       biocontamination
Annex B (informative) Guidance on validating air samplers
Annex C (informative) Guidance on determining biocontamination
                       of surfaces
Annex D (informative) Guidance on determining biocontamination
                       of textiles
Annex E (informative) Guidance on validating laundering
                       processes
Annex F (informative) Guidance on determining biocontamination
                       of liquids
Annex G (informative) Guidance on training
Bibliography

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
CEN/TC 243
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

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 13408-1:2015-12 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
14/30270614 DC : 0 BS EN 14065 - TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM
BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
UNE-EN 14065:2017 Textiles - Laundry processed textiles - Biocontamination control system
I.S. EN 14065:2016 TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM
VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
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 EN ISO 14698-2:2003 Cleanrooms and associated controlled environments. Biocontamination control Evaluation and interpretation of biocontamination data
I.S. EN ISO 14698-2:2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
PREN 17141 : DRAFT 2017 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
PREN 14065 : DRAFT 2014 TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM
BS EN 14065:2016 Textiles. Laundry processed textiles. Biocontamination control system
EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
EN 14065:2016 Textiles - Laundry processed textiles - Biocontamination control system
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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)
17/30329441 DC : 0 BS EN 17141 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL
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 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

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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