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CSA ISO 5840 : 0

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES
Available format(s)

Hardcopy , PDF

Withdrawn date

01-03-2008

Language(s)

English

1 Scope
2 Normative references
3 Definitions
4 Valve description
5 Material, component and valve assembly testing
6 Hydrodynamic testing
7 Durability testing
8 Preclinical in vivo evaluation
9 Clinical evaluation
10 Packaging, labelling and instructions
Annexes
A Rationale for the provisions of this International
    Standard
B Materials related to heart valve substitutes
C Physical and material properties of heart valve
    substitutes and their components
D Standards applicable to testing of materials and
    components of heart valve substitutes
E Definitions of components of a heart valve substitute
F Valve description

Defines tests to be performed and requirements for test apparatus to be used in determining the physical, biological and mechanical properties of heart valve substitutes of all types, and of the materials and components of which they are made.

DocumentType
Standard
Pages
50
PublisherName
Canadian Standards Association
Status
Withdrawn

Standards Relationship
ISO 5840:2005 Identical

CSA ISO 7207-1 : 0 IMPLANTS FOR SURGERY - FERMORAL AND TIBIAL COMPONENTS FOR PARTIAL AND TOTAL KNEE JOINT PROSTHESES - PART 1: CLASSIFICATION, DEFINITIONS AND DESIGNATION OF DIMENSIONS
CSA ISO 8319-1 : 0 ORTHOPAEDIC INSTRUMENTS - DRIVE CONNECTIONS - PART 1: KEYS FOR USE WITH SCREWS WITH HEXAGON SOCKET HEADS
CSA ISO 8319-2 : 0 ORTHOPAEDIC INSTRUMENTS - DRIVE CONNECTIONS - PART 2: SCREWDRIVERS FOR SINGLE SLOT HEAD SCREWS, SCREWS WITH CRUCIATE SLOT AND CROSS-RECESSED HEAD SCREWS
CSA ISO 5833 : 0 IMPLANTS FOR SURGERY - ACRYLIC RESIN CEMENTS
CSA ISO 5835 : 0 IMPLANTS FOR SURGERY - METAL BONE SCREWS WITH HEXAGONAL DRIVE CONNECTION, SPHERICAL UNDER-SURFACE OF HEAD, ASYMMETRICAL THREAD-DIMENSIONS
CSA ISO 5832-2 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 2: UNALLOYED TITANIUM
CSA ISO 5832-4 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 4: COBALT-CHROMIUM-MOLYBDENUM CASTING ALLOY
CSA ISO 5832-3 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 3: WROUGHT TITANIUM 6-ALUMINIUM 4-VANDIUM ALLOY
CSA ISO 5832-5 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 5: WROUGHT COBALT-CHROMIUM-TUNGSTEN-NICKEL ALLOY
CSA ISO 7206-2 : 0 IMPLANTS FOR SURGERY - PARTIAL AND TOTAL HIP JOINT PROSTHESES - PART 2: ARTICULATING SURFACES MADE OF METALLIC, CERAMIC AND PLASTICS MATERIALS
CSA ISO 5832-6 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 6: WROUGHT COBALT-NICKEL-CHROMIUM-MOLYBDENUM ALLOY

ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
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 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO/TR 10993-9:1994 Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation

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