AAMI 16142 2 2017
$140.32
ANSI/AAMI/ISO 16142-2:2017 – Medical devices-Recognized essential principles of safety and performance of medical devices-Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 | 56 |
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This standard identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 16142-2:2017; Medical devices—Recognized essential principles of safety and performance of medical devices—Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| 2 | Objectives and uses of AAMI standards andrecommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 8 | Background of ANSI/AAMI adoption of ISO 16142-2:2017 |
| 9 | Foreword |
| 10 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 16 | 3 Terms and definitions |
| 20 | 4 Essential principles of safety and performance of IVD medical devices |
| 21 | 5 Use of standards and guides in support of the essential principles 5.1 General approach to using standards 5.2 Types of standards useful to demonstrate compliance |
| 22 | Figure 1—Types of standards |
| 23 | 5.3 Risk management approach to demonstrating compliance 5.4 Phases of the IVD medical device life-cycle |
| 24 | Figure 2—Phases of the life-cycle 5.5 Use of standards during IVD medical device life-cycle phases 5.5.1 Design and development planning 5.5.2 Design and development including testing and validation 5.5.3 Regulatory premarket review |
| 25 | 5.5.4 Production 5.5.5 Post-production including IVD medical device use and post-market surveillance 5.5.6 End of life 5.6 Assessing the conformity of an IVD medical device |
| 26 | 6 Essential principles and references to relevant standards and guides 6.1 Use of standards by authorities having jurisdiction 6.2 Manufacturers’ use of essential principles and references to relevant standards or guides |
| 28 | Annex A (informative) Rationale and guidance A.1 General guidance A.2 Types of references A.2.1 General A.2.2 Example of normative reference to a group standard A.2.3 Example of normative reference to a product standard |
| 29 | A.2.4 Example of normative reference to identified requirements, clauses or subclauses A.2.5 Example of normative reference from a group standard to a basic standard A.2.6 Example of specifying requirement(s) supported by informative reference to group standards A.3 Rationale for particular clauses and subclauses |
| 30 | Annex B (normative) Table relating essential principles to standards B.1 General B.2 Essential principles Table B.1—General principles for all medical devices |
| 32 | Table B.2—Additional principles for IVD medical devices |
| 46 | B.3 Additional specific product standards |
| 47 | Annex C (informative) Website listings of other standards suitable for the medical device sectorand for assessment purposes |
| 48 | Annex D (informative) Reference to the essential principles by International Standards D.1 Purpose D.2 Suggested format for a reference to the essential principles annex Table D.1—Correspondence between the essential principles and this document |
| 54 | Annex E (informative) Terminology—Alphabetized index of defined terms |
| 55 | Bibliography |
