AAMI/IEC TIR80002-1:2009
Current
The latest, up-to-date edition.
MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE
Hardcopy , PDF
English
10-26-2009
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC TIR8002-1:2009
FOREWORD
INTRODUCTION
1 General
2 Terms and definitions
3 General requirements for RISK MANAGEMENT
4 RISK ANALYSIS
5 RISK EVALUATION
6 RISK CONTROL
7 Evaluation of overall residual risk acceptability
8 Risk management report
9 Production and POST-PRODUCTION information
Annex A (informative) - Discussion of definitions
Annex B (informative) - Examples of software causes
Annex C (informative) - Potential software-related pitfalls
Annex D (informative) - Life-cycle/risk management grid
Annex E (informative) - SAFETY cases
Bibliography
Index
Index of defined terms
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.