CSA ISO 5840 : 0
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
01-03-2008
English
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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Withdrawn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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