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BS ISO 18193:2021

BS ISO 18193:2021

$167.15

Cardiovascular implants and artificial organs. Cannulae for extracorporeal circulation

Published By Publication Date Number of Pages
BSI 2021 42
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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 .

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
12 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
13 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
14 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
15 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
16 5.3.4 Pull strength
5.3.5 Integrity (corrosion, abrasion, degradation)
5.3.6 Radio-detectability
17 5.4 Performance characteristics
5.4.1 Pressure drop
5.4.2 Collapse resistance
5.4.3 Recirculation
18 5.4.4 Blood cell damage
19 5.4.5 Shelf life
6 Information supplied by the manufacturer
6.1 Information to be given on the cannula
20 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
21 6.4 Information to be given in the accompanying documents in a prominent form
7 Packaging
22 Annex A (informative) Examples of connectors
32 Annex B (informative) Test set-up for kink resistance
34 Annex C (informative) Test set-up for recirculation
37 Annex D (informative) Test set-up for blood cell damage
41 Bibliography

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BS ISO 18193:2021
$167.15