ANSI AAMI ISO 5841-2 pdf free download

ANSI AAMI ISO 5841-2 pdf free download.Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads.
2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1 4708-2:201 2, Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1 4708-2 and the following apply. 3.1 advisory notification <of a device> any action taken to inform the clinicians concerned by a manufacturer who has become aware that a device might fail to conform to any claims made relating to effectiveness, benefits, performance characteristics, or safety 3.2 clinical performance period calendar period, defined by the reporting party, during which the clinical performance of a specific population sample of devices is assessed 3.3 complaint any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution [ 1 5 ] 3.4 confirmed malfunction malfunction of an implanted device, confirmed by returned product analysis, not including induced malfunctions 3.5 damaged, adj <of a device> having characteristics which have changed outside the limits stated by the manufacturer, due to some external agency 3.6 device cardiac pulse generators or leads, intended for long-term implantation 3.7 device family specified group of device model numbers with the same indications for use and designs that differ only with respect to parameters not reasonably expected to significantly affect malfunction incidence or longevity, such as pulse generator header differences or lead length 3.8 follow-up center medical center, hospital, clinic, or individual responsible for the care of a patient after the implantation of a device 3.9 implanted status of a device after the surgical incisions are closed (implant pocket closed); if relevant clinical details are not available to the manufacturer, at least one calendar day shall have passed after the implant date in order to classify the device as implanted 3.10 implant damage — leads damage which occurred after opening the lead package and during an attempt to implant the lead, i.e. the implant was not completed using the lead in question 3.11 induced malfunction — pulse generators device malfunction caused by external factors (e.g. therapeutic radiation, excessive physical damage, etc.) including but not limited to hazards addressed in product labeling Note 1 to entry: Damage to a pulse generator caused by a lead malfunction will be reported as a lead malfunction. 3.12 induced malfunction — leads lead malfunction caused by use error or other external factors (e.g. scalpel cuts, damage caused during implant, sutures applied directly to lead body, explant or after explant etc.) including applications outside of labeling recommendations or addressed in product labeling as cautions or hazards in product labeling Note 1 to entry: Damage to a lead caused by a pulse generator malfunction will be reported as a pulse generator malfunction. 3.13 in service <of a device> functioning in such a manner as to provide potential medical benefits to the patient Note 1 to entry: This term can apply to a device that may be out of specification (see 3.23 ). 3.14 in specification <of a device> having characteristics within the limits recommended by the manufacturer for clinical use.ANSI AAMI ISO 5841-2 pdf download.