BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Cleanrooms and associated controlled environments. Biocontamination control General principles and methods
Hardcopy , PDF
12-08-2020
English
27-10-2003
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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
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 |
LBI/30
|
| DevelopmentNote |
Supersedes 96/124833 DC. (10/2003)
|
| DocumentType |
Standard
|
| Pages |
44
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 14698-1:2003 | Identical |
| NBN EN ISO 14698-1 : 2004 | Identical |
| ISO 14698-1:2003 | Identical |
| NEN EN ISO 14698-1 : 2003 | Identical |
| NS EN ISO 14698-1 : 1ED 2003 | Identical |
| UNE-EN ISO 14698-1:2004 | Identical |
| I.S. EN ISO 14698-1:2003 | Identical |
| NF EN ISO 14698-1 : 2004 | Identical |
| UNI EN ISO 14698-1 : 2004 | Identical |
| ONORM EN ISO 14698-1 : 2004 | Identical |
| DIN EN ISO 14698-1:2004-04 | Identical |
| 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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