informations à fournir par le fabricant. STANDARD. ISO. Second edition . Reference number. ISO (E). Provläsningsexemplar. ISO Implants for Surgery – Active Implantable Medical Devices – Part 1: General Requirements for Safety, Marking and for Information to be Provided. It is most important that the objectives and potential uses of an. AAMI product standard or recommended practice are clearly understood. The objectives of.
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Infections should be assessed by culturing and identifying pathogens. Both the implanted product and non-implantable supporting equipment require testing and evaluation to specific standards. Combatting problems early in the design phase can save costly redesigns and additional testing later, and can allow you to avoid delays to market.
A general description of the implantable cardiac lead should be provided, including its principles of operation and the materials used in its manufacture, construction and packaging. Identify the drug substances and provide the brand or trade names of their corresponding drug products, and Drug Identification Numbers DIN.
Once implemented, Health Canada will expect manufacturers to meet the specifications listed in this guidance document. Electrical data should confirm satisfactory lead position, attachment and performance. Get a quote for certification of systems, products or services, and get certified.
Guidance Document – Medical Device Applications for Implantable Cardiac Leads
Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements. Implantable infusion pumps SFDA.
The following information should be provided for drug eluting leads:. Long-term studies may be required to assess the durability of new insulation and other materials. This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents. Alternatively, provide the name and address of the drug substance supplier DMF number and drug product manufacturer, as well as an attestation that the drug substance complies with a Schedule B pharmacopeial standard or monograph.
The following information is to be provided in an application for an investigational testing authorization, a device licence, or a licence amendment for implantable cardiac leads. General requirements for safety, marking and for information to be provided by the manufacturer SFDA.
It is intended to supplement the guidance available on general application processes and procedures for Class IV and other medical devices see Bibliography.
Guidance Document – Medical Device Applications for Implantable Cardiac Leads –
Comments from stakeholders have been considered in producing this final version. The maximum pressure that the lead tip can exert should be determined. Information technology equipment – Safety – Part 1: Drug Identification and Quantification: The defibrillation threshold in joules [J] and impedance in ohms should be measured if the device is designed for cardioversion or defibrillation.
14708- thresholds and lead impedances should be measured if the device is designed for cardioversion or defibrillation. There should also be evidence provided that confirms adequate resistance to crevice and pitting corrosion for lead connector contacts.
Where claims are made regarding lead polarization, data from bench testing should be provided to support these claims. The following validation testing is recommended:. Device deliverability may be sufficiently demonstrated through animal studies.
Implants for surgery – Active implantable medical devices – Part 2: Testing should be performed to ensure that lead functions sensing, pacing, etc. Discover also Certification, assessment, diagnosis Get a quote for certification of systems, products or services, and get certified. Implants for surgery 147088-1 Active implantable medical devices — Part 1: It is recommended that threshold values for atrial leads and ventricular leads should be determined at implantation and at appropriate intervals following implantation.
Where there are discrepancies between the Regulations and the standards referenced herein, the Regulations apply. The following sections outline recommended tests to be performed for a new implantable cardiac lead. Reporting of clinical performance of populations of pulse isso or leads SFDA.
A drug eluting component may be placed at the distal tip of the lead or on an electrode 17408-1 reduce post-implantation local inflammatory reactions in order to reduce peak pacing thresholds and increase pulse generator battery life. Anchoring Suture Sleeve Performance Test: Ensure that oso anchoring sleeves, provided premounted or as accessories, securely attach the lead when used according to the instructions for use.
William Stearns is an associate senior engineer at Interteka London, U. Legal notices Photo credits FAQ. Although the canine model is isp used to evaluate pacemaker leads, the choice of animal models is the responsibility of the manufacturer. Thank you for your help! Lead Tip Pressure and Stiffness Test: The signal obtained with the lead should not exhibit under- or over-sensing and the signal should be sufficiently stable over prolonged periods of time.
Testing izo be carried out in accordance with the methods and test flex fixtures described and illustrated in Section Testing should use fully assembled leads for a range of pulse scenarios varying amplitudes and durations. It is recommended that specimens be preconditioned by subjecting them to conditions simulating the physiological environment e.
The requirements of each subsequent part take priority over those of Part 1, as they indicate requirements, procedures, and methods of uso compliance specific to their product type.
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Pacing lead impedances should be measured. A link, button or video is not working. Clinical safety indicators include adverse events and complications associated with conductor failure, extracardiac stimulation, insulation failure, low or high pacing impedance, loss of capture, sensing problems loss, over-sensing or under-sensinglead dislodgement, perforation and other lead-related adverse events, including death.
ISO Clinical investigation of medical devices for human subjects – Good clinical practice. It is recommended that the manufacturer also verify that the 14078-1 passes through its introducer without bond delamination or insulation damage. Biological evaluation of medical devices – Part 1: