CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
7 Design verification testing and analysis/design
  validation
Annex A (informative) - Heart valve substitute
        hazards, associated failure modes, and
        evaluation methods
Annex B (informative) - In vitro procedures for
        testing unstented or similar valves in
        compliant chambers
Annex C (informative) - Preclinical in vivo
        evaluation
Annex D (informative) - Description of the
        surgical heart valve substitute
Annex E (informative) - Examples of components
        of some surgical heart valve substitutes
Annex F (informative) - Guidelines for verification
        of hydrodynamic performance
Annex G (informative) - Durability testing
Annex H (informative) - Examples of design
        specific testing
Annex I (informative) - Fatigue assessment
Annex J (normative) - Methods of evaluating
        clinical data
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on medical devices
Bibliography

Pertains to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.

DevelopmentNote	Supersedes DIN EN ISO 5840 E. (02/2016)
DocumentType	Standard
Pages	65
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
EN ISO 5840-2:2015	Identical
ISO 5840-2:2015	Identical

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 14160:2011	Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ASTM F 2503 : 2013 : REDLINE	Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
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
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 5840-1:2015	Cardiovascular implants Cardiac valve prostheses Part 1: General requirements
ISO 25539-1:2017	Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
ISO 14630:2012	Non-active surgical implants General requirements
ASTM F 2052 : 2015 : REDLINE	Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ISO 16061:2015	Instrumentation for use in association with non-active surgical implants General requirements
ISO 8601:2004	Data elements and interchange formats Information interchange Representation of dates and times
ISO 532:1975	Acoustics Method for calculating loudness level
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ASTM F 2213 : 2017 : REDLINE	Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO/TS 12417:2011	Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007	Medical devices Application of risk management to medical devices
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV	Sound level meters
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
DIN EN ISO 5840-1 E : 2015	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015)

View more information

$300.70

Including GST where applicable

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

Get in touch with us

Log into your Account

DIN EN ISO 5840-2 E : 2016

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

Access your standards online with a subscription