AAMI 12417 1 2015
$119.53
ANSI/AAMI/ISO 12417-1:2015 – Cardiovascular implants and extracorporeal systems-Vascular device-drug combination products – Part 1: General requirements
| Published By | Publication Date | Number of Pages |
| AAMI | 2015 | 63 |
Specifies requirements for vascular device-drug combination products based upon current technical and medical knowledge. Outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 12417-1:2015, Cardiovascular implants and extracorporeal systems—Vascular device-drug combination products—Part 1: General requirements |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background on AAMI adoption of ISO 12417-1:2015 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope |
| 14 | 2 Normative references 3 Terms and definitions |
| 18 | 4 Intended performance 4.1 General 4.2 Classification 4.3 Intended clinical location |
| 19 | 5 Design attributes 5.1 General 5.2 Drug-containing part of the VDDCP (DCP) 5.2.1 General 5.2.2 Matrix |
| 20 | 5.2.3 Active pharmaceutical ingredient (API) 6 Materials 7 Design evaluation 7.1 General |
| 21 | 7.2 Pre-clinical evaluation 7.2.1 Sampling 7.2.2 Conditioning of test samples |
| 22 | 7.2.3 Pre-Clinical in vitro test reports and additional information 7.2.4 Pre-clinical in vitro evaluation 7.2.4.1 Testing the device part-related attributes of the VDDCP |
| 23 | 7.2.4.2 Testing the drug-containing part-related attributes of the VDDCP 7.2.4.3 Requirements for the VDDCP related to the DCP 7.2.4.3.1 Ability to access 7.2.4.3.2 Dimensional compatibility of components 7.2.4.3.3 Ability to deploy the VDDCP and deliver the API from the DCP |
| 24 | 7.2.4.3.4 Drug content 7.2.4.3.5 Drug distribution 7.2.4.3.6 Drug release characterization |
| 25 | 7.2.4.3.7 Drug identity and purity 7.2.4.3.8 Ability to withdraw |
| 26 | 7.2.4.3.9 Functionality 7.2.4.3.10 Durability 7.2.4.3.11 Particulates |
| 27 | 7.2.4.3.12 Degradable matrix 7.2.4.3.13 Compatibility with procedural fluids 7.2.4.3.14 Corrosion 7.2.4.3.15 Magnetic resonance imaging (MRI) safety |
| 28 | 7.2.4.3.16 Biocompatibility 7.2.5 Preclinical in vivo evaluation 7.2.5.1 Purpose 7.2.5.2 Specific aims |
| 29 | 7.2.5.3 Protocol |
| 31 | 7.2.5.4 Data acquisition |
| 32 | 7.2.5.5 Test report and additional information |
| 33 | 7.3 Clinical evaluation 7.3.1 Purpose 7.3.2 Specific aims |
| 34 | 7.3.3 Clinical investigation plan |
| 35 | 7.3.4 Data acquisition |
| 37 | 7.3.5 Final report |
| 38 | 7.4 Post-market surveillance 8 Manufacturing 8.1 General 8.2 Raw material reporting and analysis of the API |
| 39 | 8.3 Raw material analysis and reporting for excipients 8.4 VDDCP batch release testing |
| 40 | 9 Sterilization 9.1 Products supplied sterile 9.1.1 Testing to support “Sterile” labelling 9.2 Products supplied non-sterile 9.3 Sterilization residuals 10 Packaging 10.1 General 10.2 Considerations for VDDCPs |
| 41 | 10.3 Impact of changes in storage and shipping temperatures on VDDCP Table 1— Examples of thermal-cycling tests 11 Information supplied by the manufacturer 11.1 General 11.2 Labelling 11.2.1 VDDCP label(s) |
| 42 | 11.2.2 Record label 11.3 Instructions for use (IFU) |
| 44 | Annex A: Definitions of potential clinical and technical events Table A.1 — Definitions of potential clinical events |
| 48 | Table A.2 — Definitions of potential technical events |
| 49 | Annex B: Local information regarding submission issues for VDDCPs B.1 Contact information for local regulatory authorities Table B.1 — Contact information for local regulatory authorities B.2 History of Ethylene Oxide sterilization residuals |
| 50 | Table B.2 — Region-specific requirements for sterilization residuals |
| 52 | B.3 Applicable documents for local guidance B.3.1 Common Technical Document (CTD) B.3.2 ICH B.3.3 ASMF/DMF |
| 53 | B.3.4 Example of a summary table for testing results |
| 55 | Bibliography |
