BS EN ISO 25539-1:2017:2018 Edition
$215.11
Cardiovascular implants. Endovascular devices – Endovascular prostheses
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 140 |
This document specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
This document is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies (e.g. dissections, transections) or to create shunts between vessels [e.g. creation of transjugular intrahepatic portosystemic shunting (TIPS)]. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses (e.g. dissections, transections, shunts) are within the scope of this document, the specific requirements and testing are not described. Similarly, specific prosthesis configurations (e.g. fenestrated, branched) are within the scope, but specific requirements and testing are not described for these devices.
This document is not applicable to vascular occluders, with the exception of contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis. Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices.
Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system. This document provides requirements beyond the requirements of ISO 10555-4, specific to the use of balloons with endovascular prostheses.
This document is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.
The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices.
NOTE 1 Cardiac valved conduits are within the scope of ISO 5840-1.
Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.
NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417.
This document does not address the requirements for, and the evaluation of, viable tissues and nonviable biologic materials used in the construction of endovascular prostheses.
The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.
NOTE 3 Absorbable materials are within the scope of ISO/TS 17137 and ISO/TR 37137.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 6 | Annex ZA(informative)Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered |
| 14 | Foreword |
| 15 | Introduction |
| 17 | 1 Scope |
| 18 | 2 Normative references 3 Terms and definitions |
| 20 | 4 General requirements for endovascular system 4.1 Type of endovascular prosthesis 4.2 Materials and construction for endovascular system |
| 21 | 4.3 Configuration and size designation for endovascular prosthesis 4.4 Intended clinical use for endovascular system |
| 22 | 4.5 Balloon designation 5 Intended performance 6 Design attributes 6.1 General 6.2 Endovascular system 6.3 Endovascular prosthesis |
| 23 | 6.4 Endovascular system and endovascular prosthesis 7 Materials 8 Design evaluation 8.1 General |
| 24 | 8.2 Sampling |
| 25 | 8.3 Conditioning of test samples 8.4 Reporting |
| 26 | 8.5 Bench and analytical tests 8.5.1 Endovascular system and delivery system |
| 28 | 8.5.2 Endovascular prosthesis |
| 34 | 8.6 Preclinical in vivo evaluation 8.6.1 Purpose 8.6.2 Specific aims |
| 35 | 8.6.3 Protocol considerations 8.6.4 Data acquisition |
| 37 | 8.6.5 Test report and additional information 8.7 Clinical evaluation 8.7.1 Purpose |
| 38 | 8.7.2 Specific aims 8.7.3 Protocol considerations |
| 39 | 8.7.4 Data acquisition |
| 42 | 8.7.5 Final report |
| 43 | 9 Post-market surveillance 10 Manufacturing 11 Sterilization 11.1 Products supplied sterile 11.2 Sterilization residuals |
| 44 | 12 Packaging 12.1 Protection from damage in storage and transport 12.1.1 General 12.1.2 Unit container 12.1.3 Outer container 12.1.4 Shipping container 12.1.5 Maintenance of sterility in transit 12.2 Labelling 12.2.1 Container label |
| 45 | 12.2.2 Record label 12.3 Instructions for use 12.3.1 General 12.3.2 Information and instructions for use for endovascular systems |
| 47 | Annex A (informative) Relationship between testing requirements and device attributes and potential failure modes |
| 61 | Annex B (informative) Description of clinical and device effects of failure |
| 65 | Annex C (informative) Bench and analytical tests |
| 73 | Annex D (informative) Test methods |
| 137 | Bibliography |
