AAMI TIR20416 2020
$136.28
AAMI/ISO TIR20416:2020, Medical devices-Post-market surveillance for manufacturers
| Published By | Publication Date | Number of Pages |
| AAMI | 2020 |
The is an adoption of AAMI/ISO TIR 20416
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/ISO TIR20416:2020; Medical devices—Post-market surveillance for manufacturers |
| 2 | Blank Page |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Registration |
| 6 | Contents Page |
| 7 | Committee representation |
| 8 | Background of AAMI adoption of ISO TR 20416 Ed.1. |
| 9 | Foreword |
| 10 | Introduction |
| 11 | Figure 1 — Inter-relationship of ISO TR 20416 with ISO 13485 and ISO 14971 standards |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 14 | 4 Purpose of post-market surveillance process |
| 15 | Figure 2 — Example schematic representation of post-market surveillance |
| 16 | 5 Planning of post-market surveillance 5.1 General 5.2 Scope of the post-market surveillance plan |
| 17 | 5.3 Objective of the post-market surveillance plan |
| 18 | Table 1 — Examples of post-market surveillance plan objectives. |
| 19 | 5.4 Responsibilities and authorities Table 2 — Example of post-market surveillance resources allocation matrix. |
| 20 | 5.5 Data collection 5.5.1 Data sources 5.5.2 Defining data collection methods |
| 21 | 5.5.3 Developing the data collection protocol 5.6 Data analysis 5.6.1 General |
| 22 | 5.6.2 Considerations concerning planning the data analysis 5.6.3 Methods for data analysis Table 3 — Examples of the objective and appropriate data analysis methods |
| 23 | 5.7 Report on data analysis |
| 24 | 5.8 Interface with other processes 6 Review of the post-market surveillance plan 6.1 Purpose of the review 6.2 Criteria |
| 25 | 6.3 Review |
| 26 | Annex A (informative) Examples of data sources Table A.1 — Examples of data sources that can be used for post-market surveillance activities |
| 36 | Annex B (informative) Examples of data analysis methods B.1 General B.2 Overview table: data analysis methods |
| 37 | Table B.1 — Examples of data sources and suggested methods for data analysis B.3 Descriptive methods for trend analysis |
| 38 | Figure B.1 — Examples of types of changes identified using trend analysis |
| 39 | Figure B.2 — Trending of monthly complaint rate B.4 Descriptive method: Bar charts |
| 40 | Figure B.3 — Bar chart showing the number of reported complaints for three medical device variants 1, 2 and 3 B.5 Descriptive method, Pareto analysis |
| 41 | Figure B.4 — Pareto diagram for complaint causes for implant instruments (product family) B.6 Qualitative techniques |
| 43 | Annex C (informative) Examples of post-market surveillance plans C.1 Example of a post-market surveillance plan for a surgical scalpel C.1.1 General C.1.2 Scope of the post-market surveillance plan C.1.3 Objective of the post-market surveillance plan C.1.4 Responsibilities and authorities |
| 44 | C.1.5 Data collection C.1.6 Data analysis C.1.7 Report on data analysis |
| 45 | C.1.8 Review of the post-market surveillance plan C.2 Example of a post-market surveillance plan for a radiation therapy system C.2.1 General C.2.2 Scope of the post-market surveillance plan C.2.3 Objective of the post-market surveillance plan C.2.4 Responsibilities and authorities |
| 46 | C.2.5 Data collection Table C.1 — Data collection and data analysis activities |
| 47 | C.2.6 Data analysis C.2.7 Report on data analysis C.2.8 Review of the post-market surveillance plan C.3 Example of a post-market surveillance plan for a drug eluting stent C.3.1 General C.3.2 Scope of the post-market surveillance plan |
| 48 | C.3.3 Objective of the post-market surveillance plan C.3.4 Responsibilities and authorities C.3.5 Data collection C.3.5.1 Passive/reactive feedback C.3.5.2 Proactive feedback |
| 49 | C.3.6 Data analysis C.3.6.1 General C.3.6.2 Post-market clinical follow-up studies |
| 50 | C.3.7 Report on data analysis C.3.8 Review of the post-market surveillance plan C.4 Example of a post-market surveillance plan for a blood glucose monitoring system C.4.1 General C.4.2 Scope of the post-market surveillance plan C.4.3 Objective of the post-market surveillance plan C.4.4 Responsibilities and authorities C.4.5 Data collection |
| 51 | C.4.6 Data analysis C.4.7 Report on data analysis C.4.8 Review of the post-market surveillance plan C.5 Example for large IVD analyser C.5.1 General C.5.2 Scope of the post-market surveillance plan |
| 52 | C.5.3 Objective of the post-market surveillance plan C.5.4 Responsibilities and authorities C.5.5 Data collection |
| 53 | C.5.6 Data analysis C.5.7 Report on data analysis |
| 54 | C.5.8 Review of the post-market surveillance plan |
| 55 | Bibliography |
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