PRICES include / exclude VAT
Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.40 Implants for surgery, prosthetics and orthotics>BS ISO 5841-2:2014 Implants for surgery. Cardiac pacemakers Reporting of clinical performance of populations of pulse generators or leads
Sponsored link
immediate downloadReleased: 2014-08-31
BS ISO 5841-2:2014 Implants for surgery. Cardiac pacemakers Reporting of clinical performance of populations of pulse generators or leads

BS ISO 5841-2:2014

Implants for surgery. Cardiac pacemakers Reporting of clinical performance of populations of pulse generators or leads

Format
Availability
Price and currency
English Secure PDF
Immediate download
325.33 USD
You can read the standard for 1 hour. More information in the category: E-reading
Reading the standard
for 1 hour
32.53 USD
You can read the standard for 24 hours. More information in the category: E-reading
Reading the standard
for 24 hours
97.60 USD
English Hardcopy
In stock
325.33 USD
Standard number:BS ISO 5841-2:2014
Pages:38
Released:2014-08-31
ISBN:978 0 580 81385 6
Status:Standard
DESCRIPTION

BS ISO 5841-2:2014


This standard BS ISO 5841-2:2014 Implants for surgery. Cardiac pacemakers is classified in these ICS categories:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, hereinafter referred to as devices. Devices to be reported has 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 benefit 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.