UNI EN 12442-1 : 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - ANALYSIS AND MANAGEMENT OF RISK
12-06-2008
12-01-2013
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).
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| Standards | Relationship |
| DIN EN 12442-1:1998-05 (Draft) | Identical |
| DIN EN 12442-1:2001-01 | Identical |
| BS EN 12442-1:2000 | Identical |
| EN 12442-1 : 2000 | Identical |
| UNE-EN 12442-1:2001 | Identical |
| I.S. EN 12442-1:2000 | Identical |
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.