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BS ISO 5841-2:2014

BS ISO 5841-2:2014

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-31-2014

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Particular reporting requirements.
Annex A (normative) - Statistical method for survival
        analysis and discussion of application of results
        obtained
Annex B (informative) - Rationale
Bibliography

Defines 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.

This part of ISO5841 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.

AnnexA 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 ISO5841 is limited by the size of population under consideration. AnnexB gives the rationale for this part of ISO5841.

Committee
CH/150/2
DevelopmentNote
Supersedes BS 6902-2(1987). (01/2001) Supersedes 99/563146 DC. (06/2005) Supersedes 13/30275206 DC. (08/2014)
DocumentType
Standard
Pages
38
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 5841-2:2014 Identical

CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers

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Hardcopy - English
PDF - English
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