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ISO 15675 : 2016

M00029483

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ISO 15675 : 2016

CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS

International Organization for Standardization

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Table of Contents

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
Bibliography

Abstract

This document specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 150
Supersedes
  • ISO 15675 : 2009
  • ISO/FDIS 15675 : 60.00 (2016)