Please select and order
€109.76
excl. VAT
CONFIGURE NOW
Norm
ÖNORM EN ISO 8637-1
Issue date: 2020 10 01
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for u...
Read more
Valid
Publisher:
Austrian Standards International
Format:
Digital | 29 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
This document does not apply to:
— extracorporeal blood circuits;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— pressure monitors for the extracorporeal blood circuit;
— air detection devices;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
— reprocessing procedures and equipment.
ÖNORM EN ISO 8637-1
2020 10 01
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilter...
Norm
↖
ÖNORM EN ISO 8637
2014 03 01
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters a...
Norm
ÖNORM EN 1283
1996 10 01
Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
Norm
Norm
ISO 10993-7:2008
Issue date :
2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Norm
ISO 10993-11:2017
Issue date :
2017 09 14
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Norm
ISO 80369-7:2021
Issue date :
2021 05 04
Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
Norm
ISO 8637-1:2017
Issue date :
2017 11 28
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators