ISO 25539-3-2011 pdf free download.Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters. 4 General requirements 4.1 Classification A vena cava filter system shall be designated by its access site (see 3.1), orientation (see 3.12), implantation site (see 3.13), type (see 3.18), materials of construction, and any surface modifications, coatings, and/or drugs. 4.2 Size The size of a filter shall be designated by the sizes of vena cava intended to be treated, if applicable. 5 Intended performance The requirements of ISO 14630 apply. 6 Design attributes 6.1 General The requirements of ISO 14630 apply. The design attributes for vena cava filters are listed in Tables A.3 to A.9, with reference to the preclinical testing necessary for evaluation of the design. It is recognized that not all tests identified in a category will be necessary or practical for any given filter and/or system. The tests considered and the rationale for selection and/or waiving of tests shall be recorded. 6.2 Sheath/dilator kit for endovascular filter system The design attributes needed to meet consistently the intended performance of the sheath/dilator shall also take into account at least the following: a) the ability to permit safe access to the intended deployment location; b) the ability to permit safe withdrawal of the dilator; c) the ability to perform cavagrams. 6.3 Filter system The design attributes needed to meet consistently the intended performance of the filter system shall also take into account at least the following: a) the ability to permit safe deliverability of the filter to the intended deployment location; b) the ability to permit accurate and safe deployment of the filter; c) the ability to permit safe withdrawal of the delivery system and introducer sheath following deployment. 6.4 Filter The design attributes needed to meet consistently the intended performance of the filter shall also take into account at least the following: a) the ability to ensure effective fixation in the intended location within the vena cava; b) the ability to maintain adequate integrity;ISO 25539-3 pdf download.
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