ANSI/AAMI/ISO 15674:2016
Current
The latest, up-to-date edition.
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
English
18-11-2016
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 15674:2016
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests and measurements to determine
compliance with this document
6 Information supplied by the manufacturer
7 Packaging
Annex A (normative) - Factors to be considered
in evaluating performance characteristics
Bibliography
Describes requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-636-8
|
| Pages |
21
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 15674:2016 | Identical |
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