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11/30219211 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES
Available format(s)

Hardcopy , PDF

Superseded date

30-04-2013

Language(s)

English

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
7 Verification testing and analysis/Design validation
Annex A (informative) - Rationale for the provisions
        of this International Standard
Annex B (informative) - Minimally invasive heart
        valve substitute hazards, associated failure
        modes and evaluation methods
Annex C (informative) - Examples and definitions of
        some physical and material properties of
        heart valve substitutes and their components
Annex D (informative) - Statistical procedures when
        using performance criteria
Annex E (informative) - In vitro test guidelines for
        paediatric devices
Annex F (informative) - Preclinical in vivo evaluation
Annex G (informative) - Echocardiographic protocol
Annex H (informative) - Valve description
Annex I (informative) - Examples of minimally invasive
        heart valve substitutes, components and
        delivery systems
Annex J (informative) - Examples of standards applicable
        to testing of materials and components of
        some heart valve substitutes
Annex K (informative) - Guidelines for verification of
        hydrodynamic performance
Annex L (informative) - Durability testing
Annex M (informative) - Fatigue assessment
Annex N (normative) - Packaging
Annex O (normative) - Product labels, instructions for
        use, and training
Annex P (normative) - Adverse event classification
        during clinical investigation
Annex Q (normative) - Sterilization
Annex R (informative) - Raw and post-conditioning
        mechanical properties
Annex S (informative) - Corrosion assessment
Bibliography
Annex ZA (informative) - Relationship between this
         International Standard and the Essential
         Requirements of EU Directive 93/42

BS EN ISO 5840-3

Committee
CH/150/2
DocumentType
Draft
Pages
112
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
PREN ISO 5840-3 : DRAFT 2011 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
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
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 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 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
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
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
ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
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 11607:2003 Packaging for terminally sterilized medical devices
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization

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