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AAMI ISO 5840 :2005

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
Available format(s)

Hardcopy , PDF

Superseded date

03-30-2016

Language(s)

English

Published date

01-01-2010

Glossary of equivalent standards
Committee representation
Background on AAMI adoption of ISO 5840:2005
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
      6.2.1 Operational specifications
      6.2.2 Performance specifications
      6.2.3 Packaging, labeling, and sterilization
  6.3 Design outputs
      6.3.1 General
      6.3.2 Examples of components of some heart
            valve substitutes
  6.4 Design transfer (manufacturing qualification)
  6.5 Risk management
      6.5.1 Hazard identification
      6.5.2 Failure mode identification
      6.5.3 Risk estimation
      6.5.4 Risk evaluation
      6.5.5 Risk control
      6.5.6 Risk review
7 Verification testing and analysis/Design validation
  7.1 General requirements
  7.2 In vitro assessment
      7.2.1 Test conditions, sample selection, and
            reporting requirements
      7.2.2 Material property assessment
      7.2.3 Hydrodynamic performance assessment
      7.2.4 Structural performance assessment
  7.3 Preclinical in vivo evaluation
      7.3.1 Overall requirements
      7.3.2 Methods
      7.3.3 Test report
  7.4 Clinical investigation
      7.4.1 Principle
      7.4.2 General
      7.4.3 Number of institutions
      7.4.4 Number of patients
      7.4.5 Duration of the study
      7.4.6 Clinical data requirements
      7.4.7 Clinical investigation report
Annexes
A Rationale for the provisions of this International
  Standard
B Heart valve substitute hazards, associated failure
  modes, and evaluation methods
C Risk assessment guidelines
D Examples and definitions of some physical and material
  properties of heart valve substitutes and their components
E Statistical procedures when using performance criteria
F In vitro procedures for testing unstented or similar
  valves in compliant chambers
G Preclinical in vivo tests
H Echocardiographic protocol
I Description of the heart valve substitute
J Figures of examples of components of some heart valve
  substitutes
K Examples of standards applicable to testing of materials
  and components of some heart valve substitutes
L Guidelines for verification of hydrodynamic performance
M Durability testing
N Examples of design specific testing
O Fatigue assessment
P Packaging
Q Labeling and instructions for use
R Methods of evaluating clinical data
S Sterilization
Bibliography

Pertains to all devices intended for implantation in human hearts, as a heart valve substitute.

Committee
WG 01
DevelopmentNote
Supersedes AAMI CVP3 (07/2002)
DocumentType
Standard
Pages
85
ProductNote
Reconfirmed 2005
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 5840:2005 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

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