AAMI ISO 5841-2 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS
English
21-07-2014
15-06-2020
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Superseded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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