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BS 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Cleanrooms and associated controlled environments. Biocontamination control General principles and methods
Available format(s)

Hardcopy , PDF

Superseded date

12-08-2020

Language(s)

English

Published date

27-10-2003

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
LBI/30
DevelopmentNote
Supersedes 96/124833 DC. (10/2003)
DocumentType
Standard
Pages
44
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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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£232.00
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