Verkkokauppa
SFS-EN ISO 1135-4:en
Transfusion equipment for medical use. Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
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ISO 1135-4:2015 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
Secondary aims of ISO 1135-4:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
ISO 1135-4:2015 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
Secondary aims of ISO 1135-4:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
ISO 14644-1:1999 Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness
ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
ISO 14644-1:1999 Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness
Tekninen komitea
Direktiivi
Vahvistuspäivä
31.12.2015
Julkaisupäivä
19.01.2016
Painos
5
Sivumäärä
23
Julkaisun kieli
englanti