Projekta Nr.ISO 25539-3:2024
Nosaukums<p class="MsoBodyText"><span lang="EN-GB">This document specifies the requirements for the evaluation of vena cava filter systems (filters and delivery systems) and the requirements with respect to nomenclature, design attributes and information supplied by the manufacturer. Guidance for the development of in vitro test methods is included in Annex D. This document is intended to be used in conjunction with ISO 14630, which specifies general requirements for the performance of non-active surgical implants.</span></p> <p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;">       </span>Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, a revision of this document will be necessary.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is applicable to vena cava filters intended to prevent symptomatic pulmonary embolism by capturing blood clots in the inferior vena cava (IVC). While this document can be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address the use of filters in other implantation sites.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is also applicable to permanent filters together with their associated delivery systems, optional filters that can be retrieved and their associated retrieval systems, and convertible filters and their associated conversion systems. While this document can be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is not applicable to </span></p> <p class="MsoBodyText"><span lang="EN-GB">—<span style="mso-tab-count: 1;">           </span>temporary filters (e.g. tethered) that need to be removed after a defined period of time,</span></p> <p class="MsoBodyText"><span lang="EN-GB">—<span style="mso-tab-count: 1;">           </span>issues associated with viable tissues and non-viable biological materials, and</span></p> <p class="MsoBodyText"><span lang="EN-GB">—<span style="mso-tab-count: 1;">           </span>procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.</span></p> <p class="MsoBodyText"><span lang="EN-GB">Although absorbable filters and filters with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these devices.</span></p> <p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;">       </span>Absorbable implants are covered in ISO/TS 17137.</span></p> <p class="MsoBodyText"><span lang="EN-GB">Although coated filters and coated filter systems are within the scope of this document, this document is not comprehensive with respect to coatings.</span></p> <p class="Note"><span lang="EN-GB">NOTE 3<span style="mso-tab-count: 1;">       </span>Vascular device-drug combination products are covered in ISO 12417-1 and some coating properties are covered in ISO 25539-4.</span></p>
Reģistrācijas numurs (WIID)80225
Darbības sfēra<p class="MsoBodyText"><span lang="EN-GB">This document specifies the requirements for the evaluation of vena cava filter systems (filters and delivery systems) and the requirements with respect to nomenclature, design attributes and information supplied by the manufacturer. Guidance for the development of in vitro test methods is included in Annex D. This document is intended to be used in conjunction with ISO 14630, which specifies general requirements for the performance of non-active surgical implants.</span></p> <p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;">       </span>Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, a revision of this document will be necessary.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is applicable to vena cava filters intended to prevent symptomatic pulmonary embolism by capturing blood clots in the inferior vena cava (IVC). While this document can be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address the use of filters in other implantation sites.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is also applicable to permanent filters together with their associated delivery systems, optional filters that can be retrieved and their associated retrieval systems, and convertible filters and their associated conversion systems. While this document can be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is not applicable to </span></p> <p class="MsoBodyText"><span lang="EN-GB">—<span style="mso-tab-count: 1;">           </span>temporary filters (e.g. tethered) that need to be removed after a defined period of time,</span></p> <p class="MsoBodyText"><span lang="EN-GB">—<span style="mso-tab-count: 1;">           </span>issues associated with viable tissues and non-viable biological materials, and</span></p> <p class="MsoBodyText"><span lang="EN-GB">—<span style="mso-tab-count: 1;">           </span>procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.</span></p> <p class="MsoBodyText"><span lang="EN-GB">Although absorbable filters and filters with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these devices.</span></p> <p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;">       </span>Absorbable implants are covered in ISO/TS 17137.</span></p> <p class="MsoBodyText"><span lang="EN-GB">Although coated filters and coated filter systems are within the scope of this document, this document is not comprehensive with respect to coatings.</span></p> <p class="Note"><span lang="EN-GB">NOTE 3<span style="mso-tab-count: 1;">       </span>Vascular device-drug combination products are covered in ISO 12417-1 and some coating properties are covered in ISO 25539-4.</span></p>
StatussStandarts spēkā
ICS grupa11.040.40