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AAMI
AAMI ISO 5841-2 : 2014

AAMI ISO 5841-2 : 2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS

Available format(s)

Hardcopy , PDF

Superseded date

06-15-2020

Language(s)

English

Published date

07-21-2014

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 5841-2:2014
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
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.

Committee
JWG 1
DocumentType
Standard
ISBN
1-57020-552-3
Pages
36
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

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 - DRM
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