AAMI TIR24971 2013 RA 2016
$75.64
AAMI/ISO TIR24971:2013/(R)2016 – Medical devices-Guidance on the application of ISO 14971
| Published By | Publication Date | Number of Pages |
| AAMI | 2013 | 27 |
Provides guidance that addresses specific areas that are problematic for those implementing a risk management system.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/ISO TIR24971:2013, Medical devices — Guidance on the application of ISO 14971 |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 6 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Background of ANSI/AAMI adoption of ISO/TS 24971:2013 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 The role of international product safety and process standards in risk management 2.1 Overview |
| 14 | 2.2 Use of international product safety standards in risk management |
| 17 | 2.3 International process standards and ISO 14971 |
| 19 | 3 Developing the policy for determining the criteria for risk acceptability |
| 20 | 4 Production and post-production feedback loop 4.1 Overview 4.2 Observation and transmission |
| 23 | 4.3 Assessment 4.4 Action |
| 24 | 5 Differentiation of information for safety and disclosure of residual risk 5.1 Difference between “information for safety” and “disclosure of residual risk” 5.2 Information for safety |
| 25 | 5.3 Disclosure of residual risk 6 Evaluation of overall residual risk 6.1 Overview |
| 26 | 6.2 Inputs and other considerations for overall residual risk evaluation |
