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AAMI 8637 1 2017

AAMI 8637 1 2017

$115.49

ANSI/AAMI/ISO 8637-1:2017, Extracorporeal systems for blood purification-Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

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AAMI 2017
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AAMI adoption: This first edition of ISO 8637-1:2017 cancels and replaces the third edition of ISO 8637:2010 and ISO 8637:2010/Amd1:2013, which has been technically revised.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 8637-1:2017; Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
3 Title page
4 AAMI Standard
Copyright information
5 Contents
6 Committee representation
8 Background of AAMI adoption of ISO 8637-1:2017
9 Foreword
10 Introduction
11 1 Scope
2 Normative references
12 3 Terms and definitions
14 4 Requirements
4.1 Biological safety
4.2 Sterility
4.3 Non-pyrogenicity
15 4.4 Mechanical characteristics
4.4.1 Structural integrity
4.4.2 Blood compartment integrity
4.4.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports
16 Figure 1 — Main fitting dimensions of blood inlet and outlet ports
17 4.4.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports
18 Figure 2 — Main fitting dimensions of dialysis fluid inlet and outlet ports
4.4.5 Haemofilter filtrate ports
4.4.6 Haemoconcentrator blood and filtrate ports
4.5 Performance characteristics
4.5.1 Solute clearance of haemodialysers and haemodiafilters
4.5.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators
19 4.5.3 Ultrafiltration coefficient
4.5.4 Volume of the blood compartment
4.5.5 Pressure drop of the blood compartment
4.6 Expiry date
5 Test methods
5.1 General
5.2 Biological safety
20 5.3 Sterility
5.4 Non-pyrogenicity
5.5 Mechanical characteristics
5.5.1 Structural integrity
5.5.1.1 General
5.5.1.2 Positive-pressure test
5.5.1.3 Negative pressure test
5.5.2 Blood compartment integrity
5.5.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports
5.5.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports
5.5.5 Haemofilter filtrate ports
5.5.6 Haemoconcentrator blood and filtrate ports
21 Figure 3 — Gauge for measuring length of engagement of the male cone of blood inlet and outlet ports
22 5.6 Performance characteristics
5.6.1 Clearance
5.6.1.1 General
5.6.1.2 Test solutions
Table 1 — Reference concentrations of test solutions
5.6.1.3 Clearance test procedure
23 Figure 4 — Diagram of open-loop system for measuring clearance of haemodialyser or haemodiafilter
5.6.1.4 Equation for calculating clearance
24 5.6.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators
5.6.2.1 General
5.6.2.2 Test solution
5.6.2.3 Sieving coefficient test procedure
5.6.2.4 Equation for sieving coefficient
25 Figure 5 — Diagram of system for measuring ultrafiltration or sieving coefficients of a haemodialyser, haemodiafilter, haemofilter or haemoconcentrator
5.6.3 Ultrafiltration coefficient
5.6.3.1 Test solution
26 5.7 Expiry date
5.6.3.2 Ultrafiltration coefficient test procedure
5.6.4 Volume of the blood compartment
5.6.5 Pressure drop of the blood compartment
5.6.5.1 General
5.6.5.2 Test fluids
5.6.5.3 Pressure drop test procedure
5.7 Expiry date
6 Labelling
6.1 Labelling on the device
27 6.2 Labelling on unit containers
28 6.3 Labelling on the outer containers
6.4 Information to be given in the accompanying documentation
31 Bibliography

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AAMI 8637 1 2017
$115.49