Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

ISO 14708-5:2010

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Implants for surgery Active implantable medical devices Part 5: Circulatory support devices
Available format(s)

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

Withdrawn date

14-05-2020

Language(s)

English

Published date

26-01-2010

ISO 14708-5:2010 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps.

ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.

DevelopmentNote
Supersedes ISO/DIS 14708-5. (01/2010)
DocumentType
Standard
Pages
47
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy

Standards Relationship
ANSI/AAMI/ISO 14708-5: 2010(R2015) Identical
AAMI ISO 14708-5 : 2010 Identical
NEN ISO 14708-5 : 2010 Identical

ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
15/30290736 DC : 0 BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
ASTM F 3020 : 2016 Performance Standard for Hand-Worn Metal Detectors Used in Safety and Security
ASTM F 2401 : 2016 : REDLINE Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
BS EN ISO 10993-4:2017 Biological evaluation of medical devices Selection of tests for interactions with blood
UNE-EN ISO 10993-4:2018 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
ASTM F 3278 : 2017 Standard Performance Specification for Hand-Held Metal Detectors Used in Safety and Security
I.S. EN ISO 10993-4:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017)

IEC 60068-1:2013 Environmental testing - Part 1: General and guidance
IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
AAMI TIR26 : 2000 VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO/TR 14283:2004 Implants for surgery Fundamental principles
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 5198:1987 Centrifugal, mixed flow and axial pumps Code for hydraulic performance tests Precision grade
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

View more information
$118.72
Including GST where applicable

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.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more