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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Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
Ensure that the anchoring sleeves, provided premounted or as accessories, securely attach the lead when used according to the instructions for use. Other useful information in this regard can be obtained in the following:.
Although the canine model is frequently used to evaluate pacemaker leads, the choice of animal models is the responsibility of the manufacturer. Other useful information in this regard can be obtained in the following: Provide supporting data indicating the maximum quantity of the active ingredient that could be provided with the lead.
This guidance document applies to applications for an investigational testing authorization, a 1708-1 licence or a licence amendment and is intended to be used by manufacturers of permanent endocardial transvenous leads with active or passive fixation mechanisms hereafter referred to as implantable cardiac leads. Report a problem or mistake on this page. An alternative approach may be used if such approach satisfies the requirements of the Regulations, and 1478-1 be discussed with the Medical Devices Bureau 14708- to filing an application.
A final report should include a summary of autopsy and histology findings for all animals used during the testing as well as the pre-operative condition of each animal and the surgical techniques used. It is intended to supplement the guidance available on general application processes and procedures for Class IV and other medical devices see Bibliography.
General requirements for safety, marking and for information to be provided by the manufacturer SFDA.
It is possible that additional testing may be required based on the specific nature of the lead. It covers devices 147081 for electrical stimulation of the central or peripheral nervous system. Equivalent validation testing is required in support of adaptors.
Gaming the Healthcare System.
Guidance Document – Medical Device Applications for Implantable Cardiac Leads
Evaluating the implantable and non-implantable equipment simultaneously has several advantages, including savings in time and costs, so manufacturers should consider an approach that incorporates both testing types.
Clinical Safety and Effectiveness Requirements: If a novel fixation feature is present, evidence should be provided that demonstrates that lead extraction is possible when required e. An examination of the factors impacting growth, or lack thereof, of reprocessing in the current healthcare environment. Both the implanted product and non-implantable supporting equipment require testing and evaluation to specific standards.
Guidance Document – Medical Device Applications for Implantable Cardiac Leads –
Identify the drug substances and provide the brand or trade names of their corresponding drug products, and Drug Identification Numbers DIN. Code s Theme s William Stearns is an associate senior engineer at Interteka London, U. Sufficient numbers of leads should be implanted into animals to draw clear conclusions. Get a quote 1478-1 certification of systems, products or services, and get certified.
Lists of National Standards
Implants for surgery – Active implantable medical devices – Part 2: Specifically, manufacturers are referred to ISO and ISO for general guidance on labelling and validation of testing in support of packaging, recommended storage conditions and resistance to 147081 during transport and handling.
This standard replaces ISO Defibrillation thresholds and lead impedances should be measured if the device is designed for cardioversion or defibrillation. Include illustrations of the device and its internal components in the form of diagrams, photographs or drawings.