🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
AAMI 8637 2 2018

AAMI 8637 2 2018

$93.55

ANSI/AAMI/ISO 8637-2: 2018, Extracorporeal systems for blood purification-Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Published By Publication Date Number of Pages
AAMI 2018 24
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Category:

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

AAMI adoption: This first edition of ISO 8637-2:2018 cancels and replaces the third edition (ISO 8638:2010), which has been technically revised.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 8637-2:2018; Extracorporeal systems for blood purification—Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
3 Title page
4 AAMI Standard
5 Copyright information
Contents
6 Committee representation
8 Background of AAMI adoption of ISO 8637-2:2018
9 Foreword
10 Introduction
11 1 Scope
2 Normative references
12 3 Terms and definitions
13 4 Requirements
4.1 Biological safety
4.2 Sterility
4.3 Non-pyrogenicity
4.4 Mechanical characteristics
4.4.1 Structural integrity
4.4.2 Connectors to haemodialyser, haemodiafilter or haemofilter
4.4.3 Connectors to vascular access device
4.4.4 Connectors to ancillary components
4.4.5 Colour coding
14 Figure 1 — Main fitting dimensions of extracorporeal blood circuit connector to blood ports of haemodialyser, haemodiafilter or haemofilter
15 4.4.6 Access ports
4.4.6.1 Needle access ports
4.4.6.2 Needleless access ports
4.4.7 Blood pathway volume
4.4.8 Air capture chamber fill level
4.4.9 Transducer protectors
4.4.9.1 Integral transducer protectors
4.4.9.2 Non-integral transducer protectors
4.4.10 Blood pathway flow dynamics
4.4.11 Pump segment performance
4.5 Expiry date
16 4.6 Tubing compliance
5 Test methods
5.1 General
5.2 Biological safety
5.3 Sterility
5.4 Non-pyrogenicity
5.5 Mechanical characteristics
5.5.1 Structural integrity
5.5.1.1 Positive pressure
17 5.5.1.2 Negative pressure
5.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter
5.5.3 Connector to vascular access device
5.5.4 Connectors to ancillary components
5.5.5 Colour coding
18 Figure 2 — Gauge for measuring length of engagement of the male cone of blood inlet and outlet ports
5.5.6 Access ports
5.5.6.1 Needle access ports
19 5.5.6.2 Needleless access ports
5.5.7 Blood pathway volume
5.5.8 Air capture chamber fill level
5.5.9 Transducer protectors
5.5.10 Blood pathway flow dynamics
5.5.11 Pump segment performance
20 Figure 3 — Test device used for ISO blood port connectors
5.6 Expiry date
5.7 Tubing compliance
21 6 Labelling
6.1 Labelling on the device
6.2 Labelling on unit containers
6.3 Labelling on the outer containers
22 6.4 Information to be given in the accompanying documentation
24 Bibliography

Related products

AAMI 8637 2 2018
$93.55