Table of Contents

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

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150
Supersedes	ISO/DIS 5841-2 : 60.00 (2014)