BS EN ISO 10993-5:2009

BS EN ISO 10993-5:2009

Biological evaluation of medical devices. Tests for in vitro cytotoxicity

Status : Current   Published : July 2009
Conformity to regulation : Designated



BS EN ISO 10993-5:2009 Biological evaluation of medical devices. Tests for in vitro cytotoxicity (ISO 10993-5:2009)

BS EN ISO 10993-5 has been revised and now contains informative annexes that identify the sections of the standard that conform to the Medical Devices Directives 93/42/EEC and 90/385/EEC, for medical devices and active implantable medical devices.

BS EN ISO 10993-1 is part of the ISO 10993 series that consists of the following parts, under the general title Biological evaluation of medical devices:

Due to the general applicability of in vitro cytotoxicity tests and their widespread use in evaluating a large range of devices and materials, it is the purpose of this part of ISO 10993, rather than to specify a single test, to define a scheme for testing which requires decisions to be made in a series of steps. This should lead to the selection of the most appropriate test.

Three categories of test are listed: extract test, direct contact test, indirect contact test.

The choice of one or more of these categories depends upon the nature of the sample to be evaluated, the potential site of use and the nature of the use.

This choice then determines the details of the preparation of the samples to be tested, the preparation of the cultured cells, and the way in which the cells are exposed to the samples or their extracts.

At the end of the exposure time, the evaluation of the presence and extent of the cytotoxic effect is undertaken.

It is the intention that BS EN ISO 10993-5 leaves open the choice of type of evaluation. Such a strategy makes available a battery of tests, which reflects the approach of many groups that advocate in vitro biological tests.

The numerous methods used and endpoints measured in cytotoxicity determination can be grouped into the following categories of evaluation:

  • Assessments of cell damage by morphological means
  • Measurements of cell damage
  • Measurements of cell growth
  • Measurements of specific aspects of cellular metabolism.

There are several means of producing results in each of these four categories. The investigator should be aware of the test categories and into which category a particular technique fits, in order that comparisons be able to be made with other results on similar devices or materials both at the intra- and interlaboratory level.

Examples of quantitative test protocols are given in annexes. Guidance for the interpretation of the results is also provided.

Contents of BS EN ISO 10993-5 include:

  • Introduction
  • Scope
  • Normative references
  • Terms and definitions
  • Sample and control preparation
  • Preparation of liquid extracts of material
  • Preparation of material for direct-contact tests
  • Preparation of controls
  • Cell lines
  • Culture medium
  • Preparation of cell stock culture
  • Test procedures
  • Number of replicates
  • Test on extracts
  • Test by direct contact
  • Test by indirect contact
  • Determination of cytotoxicity
  • Test report
  • Assessment of results
  • Neutral red uptake (NRU) cytotoxicity test
  • Colony formation cytotoxicity test
  • MTT cytotoxicity test
  • XTT cytotoxicity test
  • Bibliography

BS EN ISO 10993-5:2009 replaces BS EN ISO 10993-5:1999, which has been withdrawn.

Standard NumberBS EN ISO 10993-5:2009
TitleBiological evaluation of medical devices. Tests for in vitro cytotoxicity
Publication Date31 July 2009
Conformity to regulationDesignated
Confirm Date09 February 2017
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
ReplacesBS EN ISO 10993-5:1999
International RelationshipsEN ISO 10993-5:2009,ISO 10993-5:2009
Draft Superseded By07/30160957 DC
DescriptorsLaboratory testing, Bioassay, Biological analysis and testing, Dental equipment, Specimen preparation, Cells (biology), Test specimens, Cytotoxicity tests, Extraction methods of analysis, Toxicity, Test equipment, Medical equipment, Dental materials, Culture techniques, Testing conditions
Title in FrenchÉvaluation biologique des dispositifs médicaux. Essais concernant la cytotoxicité in vitro
Title in GermanBiologische Beurteilung von Medizinprodukten. Prüfungen auf In-vitro-Zytotoxizität
ISBN978 0 580 58259 2
File Size849 KB

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