Please select and order
€109.76
excl. VAT
Add to cart
Norm

ÖNORM EN ISO 8637-2

Issue date: 2018 11 15

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemo...
Withdrawn: 2024 09 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 27 Pages
Language:
German | English | Download GER/ENG
Optionally co-design standards:
This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This document does not apply to: — haemodialysers, haemodiafilters or haemofilters; — 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.
ÖNORM EN ISO 8637-2
2024 09 15
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for ...
Norm
ÖNORM EN ISO 8637-2
2018 11 15
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialys...
Norm
ÖNORM EN ISO 8638
2014 03 01
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers...
Norm
ÖNORM EN 1283
1996 10 01
Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
Norm
Expand
Norm
ISO 7864:2016
Issue date : 2016 08 02
Sterile hypodermic needles for single use — Requirements and test methods
Norm
ISO 10993-1:2018
Issue date : 2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Norm
ISO 10993-4:2017
Issue date : 2017 04 12
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
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
ÖNORM EN ISO 8637-2
Issue date : 2024 09 15
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
Norm
ISO 8637-2:2018
Issue date : 2018 07 20
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters