DIN EN 12442-1:1998-05 (Draft)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Procedure
5 Requirements for risk management
6 Review of risk analysis
ANNEX A (informative) Graphical representation of the risk
                      management process
ANNEX B (informative) Guidance on the application of this
                      Part of EN 12442
ANNEX C (informative) Applicability of relevant information
                      annexes in EN 1441
ANNEX D (informative) Transmissible agents risk analysis
                      and management
ANNEX ZA (informative) Clauses of this standard addressing
                       Essential Requirements or other
                       provisions of EU Directives
Bibliography

Applicable to medical devices (excluding in-vitro diagnostic medical devices) made using animal tissue or products derived from animal tissue which are or have been rendered non-viable. Specifies a procedure to investigate, using available information the safety of such devices by identifying hazards and estimating risks associated with the device (risk analysis).