DIN EN 12442-3:1998-05 (Draft)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
ANIMAL TISSUE AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
Hardcopy , PDF
01-03-2008
English
01-01-1998
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Literature search
6 Elimination and/or inactivation study of viruses and
transmissible agents
7 Final report
8 Review of final report
9 Routing monitoring and control of critical process
parameters
Annex A (normative) Requirements related to literature search
Annex B (informative) Guidance on scaling down
Annex C (informative) Guidance on the elimination and/or
inactivation study for viruses and
transmissible agents ('agents')
Annex D (informative) Statistical evaluation of virus titres
and reduction factors and assessment of
their validity
Annex E (informative) Calculation of reduction factors
Annex F (informative) Probability of detection of agents at
low concentrations
Annex ZA (informative) Clauses of this standard addressing
Essential Requirements or other
provisions of EU Directives
Bibliography
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.