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DIN EN ISO 14698-1 E : 2004

Current
Current

The latest, up-to-date edition.

CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2004

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Foreword
Introduction
I 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

Gives 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.

DocumentType
Standard
Pages
36
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current
SupersededBy

DIN 1946-4:2008-12 VENTILATION AND AIR CONDITIONING - PART 4: VAC SYSTEMS IN BUILDINGS AND ROOMS USED IN THE HEALTH CARE SECTOR

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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Hardcopy - English
PDF - English
Hardcopy - English
PDF - English
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