ISO 7199:2016
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.
ISO 7199:2016 does not apply to
- implanted oxygenators,
- liquid oxygenators,
- extracorporeal circuits (blood tubing),
- separate heat exchangers,
- separate ancillary devices, and
- separate arterial line filter.
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Foreword
Introduction
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 Blood pathway integrity
4.2.2 Heat exchanger fluid pathway integrity
4.2.3 Blood volumes
4.2.4 Connectors
4.3 Performance characteristics
4.3.1 Oxygen and carbon dioxide transfer rates
4.3.2 Heat exchanger performance factor
4.3.3 Integral arterial filtration efficiency
4.3.4 Integral arterial filter flow rate capacity
4.3.5 Integral arterial filter air handling capability
4.3.6 Blood cell damage
4.3.7 Time-dependent performance changes
4.3.8 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
5.3.2 Heat exchanger water pathway integrity
5.3.3 Blood volumes
5.3.4 Connectors
5.4 Performance characteristics
5.4.1 Oxygen and carbon dioxide transfer rates
5.4.2 Heat exchanger performance factor
5.4.3 Blood cell damage
5.4.4 Shelf life
5.4.5 Filtration efficiency
5.4.6 Integral arterial filter flow rate
5.4.7 Air-handling capability of integral arterial filter
6 Information supplied by the manufacturer
6.1 Information on the oxygenator
6.2 Information on the packaging
6.2.1 Unit container
6.2.2 Shipping container
6.3 Information in the accompanying documents
6.4 Information in the accompanying documents in a prominent form
7 Packaging
Bibliography
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Foreword
Introduction
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 Blood pathway integrity
4.2.2 Heat exchanger fluid pathway integrity
4.2.3 Blood volumes
4.2.4 Connectors
4.3 Performance characteristics
4.3.1 Oxygen and carbon dioxide transfer rates
4.3.2 Heat exchanger performance factor
4.3.3 Integral arterial filtration efficiency
4.3.4 Integral arterial filter flow rate capacity
4.3.5 Integral arterial filter air handling capability
4.3.6 Blood cell damage
4.3.7 Time-dependent performance changes
4.3.8 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
5.3.2 Heat exchanger water pathway integrity
5.3.3 Blood volumes
5.3.4 Connectors
5.4 Performance characteristics
5.4.1 Oxygen and carbon dioxide transfer rates
5.4.2 Heat exchanger performance factor
5.4.3 Blood cell damage
5.4.4 Shelf life
5.4.5 Filtration efficiency
5.4.6 Integral arterial filter flow rate
5.4.7 Air-handling capability of integral arterial filter
6 Information supplied by the manufacturer
6.1 Information on the oxygenator
6.2 Information on the packaging
6.2.1 Unit container
6.2.2 Shipping container
6.3 Information in the accompanying documents
6.4 Information in the accompanying documents in a prominent form
7 Packaging
Bibliography