I.S. EN ISO 14698-1:2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
Hardcopy , PDF
28-02-2021
English
06-11-2003
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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
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.
| DocumentType |
Standard
|
| Pages |
44
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| ONORM EN ISO 14698-1 : 2004 | Identical |
| 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 |
| BS EN ISO 14698-1:2003 | Identical |
| NF EN ISO 14698-1 : 2004 | Identical |
| UNI 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.