ANSI/AAMI/ISO 5841-2:2014 pdf download.Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads.
This part of ISo 5841 specities requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, hereinatter referred to as devices. Devices to be reported have to be market approved in one or more geographies. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate.
Annex A provides requirements for categorizing devices. It also provides normative requirements for statistical calculations, including a discussion of application of the results obtained. As with other statistical methods, the beneft of the analytical methods in this part of Iso 5841 is limited by the size of population under consideration. Annex B gives the rationale for this part of iso 5841.
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 14708- 2:2012, Implants for surgery一Active implantable medical devices一Part 2: Cardiac pacemakers
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14708-2 and the following apply.
3.1 advisory notification
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
3.3complaint
any witen, 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 distributionl"5
3.4confirmed malfunction
malfunction of an implanted device, confirmed by returned product analysis, not including induced malfunctions
3.5 damaged, adj
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 difer 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 atter 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 aplied 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.ANSI/AAMI/ISO 5841-2 pdf download.