ISO 18193:2021
Cardiovascular implants and artificial organs — Cannulae for extracorporeal circulation
This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients’ blood during cardiopulmonary bypass (CPB) up to 6 h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques. This standard does not apply to:
— introducers (e.g., guidewires) as addressed in ISO 11070,
— isolated organ perfusion cannulae, and
— intravascular catheters as addressed in ISO 10555-3.
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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 Connectors
4.2.3 Kink resistance
4.2.4 Pull strength
4.2.5 External surface
4.2.6 Integrity (corrosion, abrasion, degradation)
4.2.7 Radio-detectability
4.2.8 Distance markings
4.2.9 Lumen markings
4.3 Performance characteristics
4.3.1 Pressure drop
4.3.2 Collapse resistance
4.3.3 Recirculation
4.3.4 Blood cell damage
4.3.5 Shelf life
5 Tests and measurements for conformity to 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 Connectors
5.3.3 Kink resistance
5.3.4 Pull strength
5.3.5 Integrity (corrosion, abrasion, degradation)
5.3.6 Radio-detectability
5.4 Performance characteristics
5.4.1 Pressure drop
5.4.2 Collapse resistance
5.4.3 Recirculation
5.4.4 Blood cell damage
5.4.5 Shelf life
6 Information supplied by the manufacturer
6.1 Information to be given on the cannula
6.2 Information to be given on the packaging
6.2.1 Unit container
6.2.2 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
Annex A (informative) Examples of connectors
Annex B (informative) Test set-up for kink resistance
Annex C (informative) Test set-up for recirculation
Annex D (informative) Test set-up for blood cell damage
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 Connectors
4.2.3 Kink resistance
4.2.4 Pull strength
4.2.5 External surface
4.2.6 Integrity (corrosion, abrasion, degradation)
4.2.7 Radio-detectability
4.2.8 Distance markings
4.2.9 Lumen markings
4.3 Performance characteristics
4.3.1 Pressure drop
4.3.2 Collapse resistance
4.3.3 Recirculation
4.3.4 Blood cell damage
4.3.5 Shelf life
5 Tests and measurements for conformity to 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 Connectors
5.3.3 Kink resistance
5.3.4 Pull strength
5.3.5 Integrity (corrosion, abrasion, degradation)
5.3.6 Radio-detectability
5.4 Performance characteristics
5.4.1 Pressure drop
5.4.2 Collapse resistance
5.4.3 Recirculation
5.4.4 Blood cell damage
5.4.5 Shelf life
6 Information supplied by the manufacturer
6.1 Information to be given on the cannula
6.2 Information to be given on the packaging
6.2.1 Unit container
6.2.2 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
Annex A (informative) Examples of connectors
Annex B (informative) Test set-up for kink resistance
Annex C (informative) Test set-up for recirculation
Annex D (informative) Test set-up for blood cell damage
Bibliography