Cardiovascular implants – Endovascular devices – Part 2: Vascular stents (ISO 25539-2:2008)
DIN EN ISO 25539-2:2013-05 (E)
Cardiovascular implants – Endovascular devices – Part 2: Vascular stents (ISO 25539-
2:2012)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………………………….
Introduction ……………………………………………………………………………………………………………………………………………………
1 Scope ………………………………………………………………………………………………………………………………………………….
2 Normative references ………………………………………………………………………………………………………………………..
3 Terms and definitions ………………………………………………………………………………………………………………………..
4 General requirements ………………………………………………………………………………………………………………………..
4.1 Classification ……………………………………………………………………………………………………………………………………..
4.2 Size ……………………………………………………………………………………………………………………………………………………..
4.3 Intended clinical use designation …………………………………………………………………………………………………….
5 Intended performance ……………………………………………………………………………………………………………………….
6 Design attributes ……………………………………………………………………………………………………………………………….
6.1 General ……………………………………………………………………………………………………………………………………………….
6.2 Delivery system and stent system ……………………………………………………………………………………………………
6.3 Implant ………………………………………………………………………………………………………………………………………………..
7 Materials ……………………………………………………………………………………………………………………………………………..
8 Design evaluation ………………………………………………………………………………………………………………………………
8.1 General ……………………………………………………………………………………………………………………………………………….
8.2 Sampling …………………………………………………………………………………………………………………………………………….
8.3 Conditioning of test samples ……………………………………………………………………………………………………………
8.4 Reporting ……………………………………………………………………………………………………………………………………………
8.5 Delivery system and stent system ……………………………………………………………………………………………………
8.6 Stent ……………………………………………………………………………………………………………………………………………………
8.7 Preclinical in vivo evaluation ……………………………………………………………………………………………………………27
8.8 Clinical evaluation ……………………………………………………………………………………………………………………………..
9 Post-market surveillance …………………………………………………………………………………………………………………..34
10 Manufacturing ……………………………………………………………………………………………………………………………………34
11 Sterilization ………………………………………………………………………………………………………………………………………..34
11.1 Products supplied sterile ………………………………………………………………………………………………………………….34
11.2 Products supplied non-sterile ………………………………………………………………………………………………………….35
11.3 Sterilization residuals ………………………………………………………………………………………………………………………..35
12 Packaging …………………………………………………………………………………………………………………………………………..35
12.1 Protection from damage in storage and transport ………………………………………………………………………….35
12.2 Marking ……………………………………………………………………………………………………………………………………………….35
12.3 Information supplied by the manufacturer ………………………………………………………………………………………36