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ISO 5840-2:2015

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

28-01-2021

Language(s)

English, French

Published date

11-09-2015

ISO 5840-2:2015 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.

ISO 5840-2:2015 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.

ISO 5840-2:2015 outlines an approach for qualifying the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.

ISO 5840-2:2015 defines performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and ISO 58403 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis.

ISO 5840-2:2015 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.

ISO 5840-2:2015 excludes homografts.

DevelopmentNote
Supersedes ISO/DIS 5840-2. Together with ISO 5840-1 & ISO 5840-3, it supersedes ISO 5840. (09/2015)
DocumentType
Standard
Pages
55
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

ISO 5910:2018 Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
AAMI ISO 5840-1 : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
I.S. EN ISO 5840-1:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)
ASTM F 3211 : 2017 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
EN ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
BS EN ISO 5840-1:2015 Cardiovascular implants. Cardiac valve prostheses General requirements
UNE-EN ISO 5840-1:2016 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
DIN EN ISO 5840-1:2015-12 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
DIN EN ISO 5840-1 E : 2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015)
16/30310949 DC : 0 BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
ONORM EN ISO 5840-1 : 2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)
ISO 5840-1:2015 Cardiovascular implants Cardiac valve prostheses Part 1: General requirements

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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
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