BS EN ISO 10993-6:2016 Biological evaluation of medical devices. Tests for local effects after implantation

BS EN ISO 10993-6:2016

Biological evaluation of medical devices. Tests for local effects after implantation

Status : Current   Published : December 2016



BS EN ISO 10993-6 infographic

What is this standard about?

This is part six in a series of international standards on the biological evaluation of medical devices. This part specifies tests for assessing local effects after implantation of biomaterials intended for use in medical devices. 

Who is this standard for?

  • Medical device manufacturers
  • Laboratories and testing facilities
  • Regulators

Why should you use this standard?

This part of ISO 10993 applies to materials that are:

  • Solid and non-absorbable
  • Non-solid, such as porous materials, liquids, gels, pastes and particulates
  • Degradable and /or absorbable, which may be solid or non-solid

The objective of the tests is to characterize the history and evolution of the tissue response after implementation of a medical device/biomaterial including final integration or absorption/degradation of the material. 

It can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might have been breached in order to evaluate local tissue responses. 

This standard also supports essential requirements in two European Medical Devices Directives: 93/42/EEC and 90/385/EEC. 

NOTE: This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. 

What’s changed since the last update?

This standard was revised to make it compatible with medical devices that are implanted in the central nervous system or those making contact with peripheral nerves. This use of medical devices is rising because of the increasing use of neuro-stimulation systems to treat the symptoms of Parkinson’s Disease. This revision contains test protocols and guidelines that are specifically designed to fit this purpose. 

Standard NumberBS EN ISO 10993-6:2016
TitleBiological evaluation of medical devices. Tests for local effects after implantation
Publication Date31 December 2016
Normative References(Required to achieve compliance to this standard)ISO 10993-2:2006, ISO 10993-4:2002, ISO 10993-1:2009, EN ISO 10993-2:2006, ISO 10993-16:2010, ISO 10993-12:2012, EN ISO 10993-16:2010, EN ISO 10993-12:2012, EN ISO 10993-4:2009, EN ISO 10993-1:2009
Informative References(Provided for Information)ASTM F763, ISO 6474-2, ISO 10993-9, ASTM F981, 90/385/EEC, ISO 11979-5, ISO 5832-8, ASTM F1983, ISO 10993-11, 93/42/EEC, ASTM F748, ISO 5832-3, BS ISO 6474-1:2019, ISO 5832-5, ISO 7405, ISO 5832-2, ISO 5834-2, ISO 5832-4, ISO 5832-6, ISO 5832-7, ISO 6474-1:2019, ISO 5832-1
ReplacesBS EN ISO 10993-6:2009
International RelationshipsEN ISO 10993-6:2016,ISO 10993-6:2016
Draft Superseded By14/30261590 DC
DescriptorsLaboratory animals, Medical equipment, Biodegradability, Biological analysis and testing, Specimen preparation, Histology, Implants (surgical), Biological hazards, Tissue implantation tests, Test specimens, Dental materials, Testing conditions, Degradation, Medical technology, Compatibility
Title in FrenchÉvaluation biologique des dispositifs médicaux. Essais concernant les effets locaux après implantation
Title in GermanBiologische Beurteilung von Medizinprodukten. Prüfungen auf lokale Effekte nach Implantationen
ISBN978 0 580 78685 3
File Size2.094 MB

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