• 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

DIN EN ISO 5840-1 E : 2015

Current
Current

The latest, up-to-date edition.

CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

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) - Rationale for the provisions
        of this part of ISO 5480
Annex B (normative) - Packaging
Annex C (normative) - Product labels, instructions for
        use, and training
Annex D (normative) - Sterilization
Annex E (informative) - In vitro test guidelines for
        paediatric devices
Annex F (informative) - Statistical procedures when
        using in vitro performance criteria
Annex G (informative) - Examples and definitions
        of some physical and material properties
        of heart valve systems
Annex H (informative) - Examples of standards applicable
        to testing of materials and components of heart
        valve systems
Annex I (informative) - Raw and post-conditioning
        mechanical properties for support
        structure materials
Annex J (informative) - Corrosion assessment
Annex K (informative) - Echocardiographic protocol
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 human implantation and provides general requirements.

DocumentType
Standard
Pages
66
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
ISO 5840-1:2015 Identical
EN ISO 5840-1:2015 Identical

DIN EN ISO 5840-2 E : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
DIN EN ISO 25539-1:2017-09 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)

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 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the 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
DIN EN ISO 5840-2:2016-05 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
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
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 532:1975 Acoustics Method for calculating loudness level
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 5840-3:2013 Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques
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 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 14971:2007 Medical devices Application of risk management to medical devices
ISO 5840-2:2015 Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV Sound level meters

View more information
£158.32
Excluding VAT

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.