BS EN ISO 10993-4:2017 Biological evaluation of medical devices. Selection of tests for interactions with blood

BS EN ISO 10993-4:2017

Biological evaluation of medical devices. Selection of tests for interactions with blood

Status : Current   Published : May 2017



What is this standard about?

It is a specification stating general requirements for evaluating the interactions of medical devices with blood. 

Who is this standard for?

Test laboratories and medical devices manufacturers.

Why should you use this standard?

Because it describes: 

  • A classification of medical devices intended for use in contact with blood, based on the intended use and duration of contact defined in BS EN ISO 10993-1
  • The fundamental principles governing the evaluation of the interaction of devices with blood
  • The rationale for structured test selection according to specific categories, together with the principles and scientific basis of these tests

What’s changed since the last update?

The 2009 version was updated to match the current tools and techniques used to evaluate medical device blood material interactions. This includes a more current description of in vitro techniques that rely less on the use of animals and generate more predictive results.

Standard NumberBS EN ISO 10993-4:2017
TitleBiological evaluation of medical devices. Selection of tests for interactions with blood
Publication Date25 May 2017
Normative References(Required to achieve compliance to this standard)ISO 10993-1:2009, ISO 10993-12:2012
Informative References(Provided for Information)ISO 10993, 93/42/EEC, ANSI/AAMI RD16:2007, ISO 5840, GB/T 16175, ISO/IEC 17025:2005, ISO 15675:2016, ISO 8637:2010, ASTM F1841 - 97(2013), ASTM F2065 - 00(2010), ISO 7198:2016, ISO 7199:2016, ASTM F2888 - 13, ISO 3826-3:2006, ISO 15674:2016, ASTM F1984 - 99(2013), ISO 14708-2:2012, ASTM F2382 - 04(2010), ASTM F1830 - 97(2013), ISO 12891-1:2015, ISO 5841-3:2013, ISO 14708-5:2010
ReplacesBS EN ISO 10993-4:2009, BS EN ISO 10993-4:2002
International RelationshipsISO 10993-4:2017,EN ISO 10993-4:2017
Draft Superseded By15/30290736 DC
DescriptorsMedical equipment, Biological analysis and testing, Medical instruments, Medical technology, Blood, Blood coagulation, Haematology, Dental materials, Dental equipment, Biological hazards
Title in FrenchÉvaluation biologique des dispositifs médicaux Choix des essais pour les interactions avec le sang
Title in GermanBiologische Beurteilung von Medizinprodukten Auswahl von Prüfungen zur Wechselwirkung mit Blut
ISBN978 0 580 84457 7
File Size3.243 MB

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