UNI EN ISO 5840-3 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
07-01-2014
01-01-2013
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) - Rationale for the provisions
of this part of ISO 5840
Annex B (informative) - Examples of transcatheter heart
valve substitutes, components and delivery systems
Annex C (normative) - Packaging
Annex D (normative) - Product labels, instructions for
use and training
Annex E (normative) - Sterilization
Annex F (informative) - Valve description
Annex G (informative) - Transcatheter heart valve substitute
hazards, associated failure modes and
evaluation methods
Annex H (informative) - In vitro test guidelines for
paediatric devices
Annex I (informative) - Statistical procedures when
using performance criteria
Annex J (informative) - Examples and definitions of
some physical and material properties of
transcatheter heart valve substitutes and
their components
Annex K (informative) - Examples of standards applicable
to testing of materials and components of
transcatheter heart valve substitutes
Annex L (informative) - Raw and post-conditioning
mechanical properties for support structure
materials
Annex M (informative) - Corrosion assessment
Annex N (informative) - Guidelines for verification of
hydrodynamic performance
Annex O (informative) - Durability testing
Annex P (informative) - Fatigue assessment
Annex Q (informative) - Preclinical in vivo evaluation
Annex R (normative) - Adverse event classification
during clinical investigation
Annex S (informative) - Echocardiographic protocol
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Specifies an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 5840-3:2013 | Identical |
| EN ISO 5840-3:2013 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| 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 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 |
| ISO 5840:2005 | Cardiovascular implants Cardiac valve prostheses |
| 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 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| ISO 1135-1:1987 | Transfusion equipment for medical use Part 1: Glass transfusion bottles, closures and caps |
| 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 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ASTM F 2213 : 2017 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| 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 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO/TS 11135-2:2008 | Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| 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 |
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