ISO 25539-4:2021 pdf download – Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices.
2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 12417-1:2015, Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements ISO/TS 17137:2021, Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants ISO 17327-1:2018, Non-active surgical implants — Implant coating — Part 1: General requirements ISO 25539-1:2017, Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses ISO 25539-2:2020, Cardiovascular implants — Endovascular devices — Part 2: Vascular stents ISO 25539-3:2011, Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters 3? Terms? and? definitions For the purposes of this document, the terms and definitions given in ISO 12417-1:2015, ISO/ TS 17137:2021, ISO 17327-1:2018, ISO 25539-1:2017, ISO 25539-2:2020, ISO 25539-3:2011 and the following apply.
4.3 Endovascular prostheses The requirements for vascular stents provided in 4.2 also apply to endovascular prostheses. References to ISO 25539-2 requirements and test methods in 4.2 shall be replaced with the ISO 25539-1 references. The simulated use and fatigue and durability in vitro testing methods provided in ISO 25539-1 do not specifically mention coatings. However, these methods may be augmented with appropriate inspections for coating damage. ISO 25539-1 lists particulate generation as a potential failure mode but does not contain a specific requirement or test method regarding particulate generation. Particulate generation is included and is evaluated as part of the simulated use test method. ASTM F2743 [1] is not directly applicable to endovascular prostheses. However, the content can inform testing for coated endovascular prostheses. 4.4? Vena? cava? filters The requirements for stents provided in 4.2 also apply to vena cava filters. References to ISO 25539-2 requirements and test methods in 4.2 shall be replaced with the ISO 25539-3 references. The simulated use and fatigue/durability testing methods provided in ISO 25539-3 do not specifically address coatings. However, these methods may be augmented with appropriate coating inspections. ISO 25539- 3 does not contain a specific requirement or test method regarding particulate generation. If deemed necessary through the device evaluation strategy, the method provided in ISO 25539-2 may be used as appropriate to evaluate particulate generation of coated filters. ASTM F2743 [1] is not directly applicable to vena cava filters. However, the content can inform testing for coated vena cava filters.