ISO 15674:2001
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
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Cardiovascular implants and artificial organs— Hard-shell cardiotomy/venous reservoir systems (w...
Contents Page
Foreword
Cardiovascular implants and artificial organs— Hard-shell cardiotomy/venous reservoir systems (w...
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Biological characteristics
4.1.1 Sterility and non-pyrogenicity
4.1.2 Biocompatibility
4.2 Physical characteristics
4.2.1 General
4.2.2 Blood volumes
4.2.3 Connectors
4.3 Performance characteristics
4.3.1 Cell damage
4.3.2 Air-handling capacity
4.3.3 Priming volume of the filters (where applicable)
4.3.4 Defoaming characteristics
4.3.5 Volume calibration
4.3.6 Filtration efficiency
4.3.7 Break-through volume
4.3.8 Dynamic priming volume
5 Tests and measurements to determine compliance with this International Standard
5.1 General
5.1.1 Tests and measurements shall be performed with the device under test prepared according ...
5.1.2 Operating variables shall be those specified by the manufacturer for intended clinical u...
5.1.3 Unless otherwise stated, the temperature of test liquids shall be
5.1.4 If the relationship between variables is non-linear, sufficient determinations shall be ...
5.1.5 The test or measurement procedures shall be regarded as reference procedures. Other proc...
5.2 Biological characteristics
5.2.1 Sterility and non-pyrogenicity
5.2.2 Biocompatibility
5.3 Physical characteristics
5.3.1 Determination of blood pathway integrity for soft venous reservoir bags
5.3.2 Determination of blood pathway integrity for sealed hard-shell reservoirs
5.3.2.1 Perform the test with air or water at the appropriate pressures.
5.3.2.2 Subject the blood pathway of the device to a negative or positive pressure of 1,5time...
5.3.3 Test liquid
5.3.4 Connectors
6 Information supplied by the manufacturer
6.1 Information to be given on the reservoir (labelling)
6.2 Information to be given on the packaging
6.2.1 Information to be given on the unit container
6.2.2 Information to be given on the shipping container
6.3 Information to be given in the accompanying documents
6.4 Information to be given in the accompanying documents in a prominent form
7 Packaging
Factors to be considered in evaluating performance characteristics
Bibliography
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Cardiovascular implants and artificial organs— Hard-shell cardiotomy/venous reservoir systems (w...
Contents Page
Foreword
Cardiovascular implants and artificial organs— Hard-shell cardiotomy/venous reservoir systems (w...
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Biological characteristics
4.1.1 Sterility and non-pyrogenicity
4.1.2 Biocompatibility
4.2 Physical characteristics
4.2.1 General
4.2.2 Blood volumes
4.2.3 Connectors
4.3 Performance characteristics
4.3.1 Cell damage
4.3.2 Air-handling capacity
4.3.3 Priming volume of the filters (where applicable)
4.3.4 Defoaming characteristics
4.3.5 Volume calibration
4.3.6 Filtration efficiency
4.3.7 Break-through volume
4.3.8 Dynamic priming volume
5 Tests and measurements to determine compliance with this International Standard
5.1 General
5.1.1 Tests and measurements shall be performed with the device under test prepared according ...
5.1.2 Operating variables shall be those specified by the manufacturer for intended clinical u...
5.1.3 Unless otherwise stated, the temperature of test liquids shall be
5.1.4 If the relationship between variables is non-linear, sufficient determinations shall be ...
5.1.5 The test or measurement procedures shall be regarded as reference procedures. Other proc...
5.2 Biological characteristics
5.2.1 Sterility and non-pyrogenicity
5.2.2 Biocompatibility
5.3 Physical characteristics
5.3.1 Determination of blood pathway integrity for soft venous reservoir bags
5.3.2 Determination of blood pathway integrity for sealed hard-shell reservoirs
5.3.2.1 Perform the test with air or water at the appropriate pressures.
5.3.2.2 Subject the blood pathway of the device to a negative or positive pressure of 1,5time...
5.3.3 Test liquid
5.3.4 Connectors
6 Information supplied by the manufacturer
6.1 Information to be given on the reservoir (labelling)
6.2 Information to be given on the packaging
6.2.1 Information to be given on the unit container
6.2.2 Information to be given on the shipping container
6.3 Information to be given in the accompanying documents
6.4 Information to be given in the accompanying documents in a prominent form
7 Packaging
Factors to be considered in evaluating performance characteristics
Bibliography