Name: ANSI/AAMI/ISO 15676:2016
Brand: AAMI
Price: 123.55 GBP

CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

18-11-2016

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
ISO 15676:2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests and measurements
6 Information supplied by the
manufacturer
7 Packaging
Bibliography

Describes requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO).

Committee	ISO/TC 150
DocumentType	Standard
ISBN	978-1-57020-638-2
Pages	19
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current

Standards	Relationship
ISO 15676:2016	Identical

ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ASTM D 792 : 2013 : REDLINE	Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
ISO 9352:2012	Plastics — Determination of resistance to wear by abrasive wheels
ISO 34-1:2015	Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces
ISO 10993-11:2017	Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-7:2008	Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 11137-2:2013	Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ASTM D 638 : 2014 : REDLINE	Standard Test Method for Tensile Properties of Plastics
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 527-1:2012	Plastics Determination of tensile properties Part 1: General principles
ISO 868:2003	Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore hardness)

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ANSI/AAMI/ISO 15676:2016

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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