BS EN ISO 22442-1:2015 – TC:2020 Edition
$217.84
Tracked Changes. Medical devices utilizing animal tissues and their derivatives – Application of risk management
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 83 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | compares BS EN ISO 22442-1:2015 |
| 2 | TRACKED CHANGES Text example 1 — indicates added text (in green) |
| 47 | European foreword |
| 49 | Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC |
| 52 | Foreword |
| 53 | Introduction |
| 55 | 1 Scope 2 Normative references |
| 56 | 3 Terms and definitions |
| 57 | 4 Risk management process 4.1 General 4.2 Risk analysis 4.2.1 Identification of qualitative and quantitative characteristics related to the safety of medical devices |
| 58 | 4.2.2 Identification of hazards and hazardous situations |
| 59 | 4.3 Risk evaluation 4.4 Risk control 4.4.1 General 4.4.2 Risk control for viruses and TSE agents 4.4.3 Risk control of other hazards |
| 60 | 4.4.4 Residual risk evaluation 4.5 Evaluation of overall residual risk acceptability 4.5.1 General 4.5.2 Documentation |
| 61 | 4.6 Production and post-production information system |
| 62 | Annex A (informative) Guidance on the application of this part of ISO 22442 |
| 63 | Annex B (informative) Graphical representation of part of the risk management process for medical devices utilizing animal material |
| 65 | Annex C (normative) Special requirements for some animal materials considering the risk management for TSE agents |
| 70 | Annex D (informative) Information relevant to the management of TSE risk |
| 79 | Bibliography |
