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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
07-23-2013
09-01-2003
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
Describes 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.
| Committee |
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Superseded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 E : 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 |
| EN ISO 14698-2:2003/AC:2006 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: 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 |
| DIN EN 14583 E : 2004 | WORKPLACE ATMOSPHERES - VOLUMETRIC BIOAEROSOL SAMPLING DEVICES - REQUIREMENTS AND TEST METHODS |
| 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 |
| 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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