EN ISO 14698-1:2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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)
23-07-2013
01-09-2003
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Superseded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 |
Standards | Relationship |
ONORM EN ISO 14698-1 : 2004 | Identical |
NF EN ISO 14698-1 : 2004 | Identical |
ISO 14698-1:2003 | Identical |
NBN EN ISO 14698-1 : 2004 | Identical |
NEN EN ISO 14698-1 : 2003 | Identical |
NS EN ISO 14698-1 : 1ED 2003 | Identical |
I.S. EN ISO 14698-1:2003 | Identical |
PN EN ISO 14698-1 : 2004 | Identical |
UNI EN ISO 14698-1 : 2004 | Identical |
SN EN ISO 14698-1 :2003 | Identical |
SS-EN ISO 14698-1 : 2003 | Identical |
BS EN ISO 14698-1:2003 | Identical |
UNE-EN ISO 14698-1:2004 | Identical |
DIN EN ISO 14698-1:2004-04 | 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 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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