UNI EN ISO 5840 : 2009

Name: UNI EN ISO 5840 : 2009
Brand: UNI

Superseded

View Superseded by

CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES

Superseded date

10-09-2022

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
  6.1 Intended use
  6.2 Design inputs
  6.3 Design outputs
  6.4 Design transfer (manufacturing qualification)
  6.5 Risk management
7 Verification testing and analysis/Design validation
  7.1 General requirements
  7.2 In vitro assessment
  7.3 Preclinical in vivo evaluation
  7.4 Clinical investigation
Annex A (informative) - Rationale for the provisions of
        this International Standard
Annex B (informative) - Heart valve substitute hazards,
        associated failure modes and evaluation methods
Annex C (informative) - Risk assessment guidelines
Annex D (informative) - Examples and definitions of some
        physical and material properties of heart valve
        substitutes and their components
Annex E (informative) - Statistical procedures when using
        performance criteria
Annex F (informative) - In vitro procedures for testing
        unstented or similar valves in compliant chambers
Annex G (informative) - Preclinical in vivo tests
Annex H (informative) - Echocardiographic protocol
Annex I (informative) - Description of the heart valve
        substitute
Annex J (informative) - Figures of examples of components
        of some heart valve substitutes
Annex K (informative) - Examples of standards applicable
        to testing of materials and components of some heart
        valve substitutes
Annex L (informative) - Guidelines for verification of
        hydrodynamic performance
Annex M (informative) - Durability testing
Annex N (informative) - Examples of design specific testing
Annex O (informative) - Fatigue assessment
Annex P (normative) - Packaging
Annex Q (normative) - Labelling and instructions for use
Annex R (normative) - Methods of evaluating clinical data
Annex S (normative) - Sterilization
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC
Bibliography

Applies to all devices intended for implantation in human hearts, as a heart valve substitute. Also applies to both newly developed and modified heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.

DevelopmentNote	Supersedes UNI EN 12006-1. (03/2006)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 5840-2 : 2015
Supersedes	UNI EN ISO 5840 : 2006

Standards	Relationship
NF EN ISO 5840 : OCT 2009	Identical
DIN EN ISO 5840:2009-08	Identical
NBN EN ISO 5840 : 2009	Identical
EN ISO 5840:2009	Identical
BS EN ISO 5840:2009	Identical
NS EN ISO 5840 : 2009	Identical
NEN EN ISO 5840 : 2009	Identical
ISO 5840:2005	Identical
I.S. EN ISO 5840:2009	Identical
SN EN ISO 5840 : 2009	Identical
UNE-EN ISO 5840:2009	Identical

EN 12442-3 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
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
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 14630:2012	Non-active surgical implants General requirements
ISO/IEC Guide 51:2014	Safety aspects Guidelines for their inclusion in standards
ISO 8601:2004	Data elements and interchange formats Information interchange Representation of dates and times
ISO 532:1975	Acoustics Method for calculating loudness level
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11607:2003	Packaging for terminally sterilized medical devices
EN 12442-1 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
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
MIL-STD-1629 Revision A:1980	PROCEDURES FOR PERFORMING A FAILURE MODE, EFFECTS AND CRITICALITY ANALYSIS
ISO 11137:1995	Sterilization of health care products Requirements for validation and routine control Radiation sterilization
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV	Sound level meters
EN 12442-2 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING