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STANDARD

Current

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)

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration. This document does not apply to: - haemodialysers, haemodiafilters or haemofilters; - plasmafilters; - haemoperfusion devices; - vascular access devices.

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General information on ÖNORM EN ISO 8637-2

Format

Paper | 40 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 8637-2 from 1996 til today.

• ÖNORM EN ISO 8637-2

  2024 09 15 Standard ÖNORM EN ISO 8637-2, Edition: 2024 09 15

  Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for ...
• ÖNORM EN ISO 8637-2

  2018 11 15 Standard ÖNORM EN ISO 8637-2, Edition: 2018 11 15

  Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialys...
• ÖNORM EN ISO 8638

  2014 03 01 Standard ÖNORM EN ISO 8638, Edition: 2014 03 01

  Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers...
• ÖNORM EN 1283

  1996 10 01 Standard ÖNORM EN 1283, Edition: 1996 10 01

  Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 10993-1:2018	Titel Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)	Ausgabedatum 2018 08 17	Art Standard	Zur Produktseite
Dokumentnummer ISO 10993-11:2017	Titel Biological evaluation of medical devices — Part 11: Tests for systemic toxicity	Ausgabedatum 2017 09 14	Art Standard	Zur Produktseite
Dokumentnummer ISO 10993-4:2017	Titel Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood	Ausgabedatum 2017 04 12	Art Standard	Zur Produktseite
Dokumentnummer ISO 11607-1:2019	Titel Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems	Ausgabedatum 2019 01 31	Art Standard	Zur Produktseite
Dokumentnummer ISO 11607-2:2019	Titel Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes	Ausgabedatum 2019 01 31	Art Standard	Zur Produktseite
Dokumentnummer ISO 11737-2:2019	Titel Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process	Ausgabedatum 2019 12 02	Art Standard	Zur Produktseite
Dokumentnummer ISO 20417:2021	Titel Medical devices — Information to be supplied by the manufacturer (Corrected version 2021-12)	Ausgabedatum 2021 04 13	Art Standard	Zur Produktseite
Dokumentnummer ISO 7864:2016	Titel Sterile hypodermic needles for single use — Requirements and test methods	Ausgabedatum 2016 08 02	Art Standard	Zur Produktseite
Dokumentnummer ISO 80369-20:2015	Titel Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods	Ausgabedatum 2015 05 11	Art Standard	Zur Produktseite
Dokumentnummer ISO 80369-7:2021	Titel Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications	Ausgabedatum 2021 05 04	Art Standard	Zur Produktseite

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