ISO 25539-3-2011 pdf free.Cardiovascular implants – Endovascular devices – Part 3: Vena cava filters.
This part of ISO 25539 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer, This part of ISO 25539 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
The following are within the scope of this part of ISO 25539:
— vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava (IVC). While this part of ISO 25539 might be useful with respect to filters implanted in other venous locations (e.g. superioi vena cava, iliac veins), it does not specifically address use of fitters in other implantation sites;
— sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrievallconversion of the vena cava filter;
delivery systems, providing that they comprise an integral component of the deployment of the vena cava filter;
optional filters that can be retrieved or converted, and permanent filters together with their associated endovascular systems. While this part of ISO 25539 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning.
The following are outside the scope of this part of ISO 25539:
— temporary filters (e.g. tethered) that need to be removed after a defined period of time; coatings, surface modifications, andloi drugs;
issues associated with viable tissues and non-viable biological materials;
— degradation and other time-dependent aspects of absorbable materials;
– procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edWon of the referenced document (including any amendments) applies.
ISO 10993 (all parts), Biological evaluation of medical devices
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Pail 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 14630, Non-active surgical implants — General requirements
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17665-1 * Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14630 and the following apply.
3.1 access site
vein that is used for accessing the vena cava
EXAMPLE Jugular vein: temoral vein: subclavian vein: antecubital vein.
3.2 adverse event clinical event
complication, failure or device-related observation with preclinical in vivo and clinical use of the endovascular system or endovascular retrieval/conversion system
NOTE 1 This term relates to the definition of a hazardous s4uation that might lead to hami, as found in ISO 14971, when the consequences are to the patient.
NOTE 2 A clinical event might lead to a detrimental clinical effect.ISO 25539-3 pdf download.
Tags: Cardiovascular implants
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