I.S. EN 1174-2:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - PART 2: GUIDANCE
Hardcopy , PDF
06-16-2006
English
01-01-1997
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.
Introduction
1 Scope
2 Normative reference
3 Definitions
4 General
4.1 Operation of the laboratory
4.2 Equipment and materials
4.3 Microbiological media
5 Selection of technique
5.1 General
5.2 Elements of bioburden estimation
5.3 Selection of media and incubation conditions
6 Validation of bioburden techniques
6.1 General
6.2 Validation of technique for removal of micro-
organisms
6.3 Validation of enumeration methods
7 Use of technique
7.1 General
7.2 Limit setting for process monitoring
7.3 Trend analysis for process monitoring
7.4 Sampling frequency for process monitoring
Annex A (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions
of EU Directives
Important note : All end users must be registered with an Account prior to user licenses being assigned.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.