ISO 15674:2016
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
ISO 15674:2016 specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery.
It applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.
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Foreword
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 Blood cell damage
4.3.2 Air-handling capacity
4.3.3 Priming volume of the reservoirs in accordance with the manufacturer’s quality control management system
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
4.3.9 Minimum and maximum volumes
4.3.10 Shelf life
5 Tests and measurements to determine compliance with this document
5.1 General
5.2 Biological characteristics
5.2.1 Sterility and non-pyrogenicity
5.2.2 Biocompatibility
5.3 Physical characteristics
5.3.1 Blood pathway integrity for soft venous reservoir bags
5.3.2 Blood pathway integrity for sealed hard-shell reservoirs
5.3.3 Connectors
5.3.4 Blood cell damage
5.3.5 Filtration efficiency
5.3.6 Shelf life
6 Information supplied by the manufacturer
6.1 Information on the reservoir (labelling)
6.2 Information on the packaging
6.2.1 Information on the unit container
6.2.2 Information on the shipping container
6.3 Information in the accompanying documents
6.4 Information in the accompanying documents in a prominent form
7 Packaging
Annex A (normative) Factors to be considered in evaluating performance characteristics
Bibliography
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Foreword
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 Blood cell damage
4.3.2 Air-handling capacity
4.3.3 Priming volume of the reservoirs in accordance with the manufacturer’s quality control management system
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
4.3.9 Minimum and maximum volumes
4.3.10 Shelf life
5 Tests and measurements to determine compliance with this document
5.1 General
5.2 Biological characteristics
5.2.1 Sterility and non-pyrogenicity
5.2.2 Biocompatibility
5.3 Physical characteristics
5.3.1 Blood pathway integrity for soft venous reservoir bags
5.3.2 Blood pathway integrity for sealed hard-shell reservoirs
5.3.3 Connectors
5.3.4 Blood cell damage
5.3.5 Filtration efficiency
5.3.6 Shelf life
6 Information supplied by the manufacturer
6.1 Information on the reservoir (labelling)
6.2 Information on the packaging
6.2.1 Information on the unit container
6.2.2 Information on the shipping container
6.3 Information in the accompanying documents
6.4 Information in the accompanying documents in a prominent form
7 Packaging
Annex A (normative) Factors to be considered in evaluating performance characteristics
Bibliography