BS EN ISO 10993-6:2009 - Biological evaluation of medical devices. Tests for local effects after implantation – BSI British Standards

BS EN ISO 10993-6:2009

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

Status : Superseded, Withdrawn   Published : June 2009 Replaced By : BS EN ISO 10993-6:2016

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BS EN ISO 10993-6:2009 Biological evaluation of medical devices. Tests for local effects after implantation

BS EN ISO 10993-6 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.

BS EN ISO 10993-6 applies to materials that are:

Solid and non-biodegradable
Degradable and/or resorbable
Non-solid, such as porous materials, liquids, pastes and particulates.

The test specimen is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test specimen in terms of mechanical or functional loading. BS EN ISO 10993-6 may also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining may have been breached, in order to evaluate local tissue responses.

The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by control materials used in medical devices of which the clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or resorption/degradation of the material. In particular for degradable/resorbable materials the degradation characteristics of the material and the resulting tissue response should be determined.

BS EN ISO 10993-6 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects may provide insight into some of these properties. Systemic toxicity studies conducted by implantation may satisfy the requirements of BS EN ISO 10993-6.

Contents of BS EN ISO 10993-6:2009

  • Foreword
  • Scope
  • Normative references
  • Terms and definitions
  • Common provisions for implantation test methods
  • General
  • Preparation of specimens for implantation
  • Test methods, general aspects
  • Tissue and implantation site
  • Animals
  • Test periods
  • Surgery and testing conditions
  • Evaluation
  • Test report
  • General considerations regarding implantation periods and tissue responses to
  • degradable/resorbable materials
  • Test methods for implantation in subcutaneous tissue
  • Test method for implantation in muscle
  • Test method for implantation in bone
  • Examples of evaluation of local biological effects after implantation
  • Bibliography



Standard NumberBS EN ISO 10993-6:2009
TitleBiological evaluation of medical devices. Tests for local effects after implantation
StatusSuperseded, Withdrawn
Publication Date30 June 2009
Withdrawn Date31 December 2016
Normative References(Required to achieve compliance to this standard)ISO 10993-16, ISO 10993-1:2003, ISO 10993-2, ISO 10993-11, ISO 10993-12
Informative References(Provided for Information)ISO 5832-8, ASTM F981, ASTM F1983, ASTM F763, ASTM F748, 93/42/EEC, 90/385/EEC, ISO 10993-9, ISO 5832-6, ISO 6474, ISO 5832-3, ISO 5832-1, ISO 5832-5, ISO 5832-4, ISO 5834-2, ISO 5832-7, ISO 5832-2, ISO 7405
Replaced ByBS EN ISO 10993-6:2016
ReplacesBS EN ISO 10993-6:2007
International RelationshipsEN ISO 10993-6:2009,ISO 10993-6:2007
DescriptorsDegradation, Histology, Biodegradability, Test specimens, Medical technology, Laboratory animals, Compatibility, Specimen preparation, Testing conditions, Medical equipment, Biological analysis and testing, Implants (surgical), Dental materials, Biological hazards, Tissue implantation tests
ICS11.100.20
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
CommitteeCH/194
ISBN978 0 580 65662 0
PublisherBSI
FormatA4
DeliveryNo
Pages32
File Size382 KB
Price£182.00


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