BS EN ISO 10993-7:2008
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BS EN ISO 10993-7:2008

Biological evaluation of medical devices. Ethylene oxide sterilization residuals

Status : Current, Work in hand   Published : December 2008
Conformity to regulation : Designated



What is BS EN ISO 10993-7:2008?

BS EN ISO 10993 looks at the biological analysis and testing of sterile equipment by specifying the allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrins (ECH). The standard also focuses on measurement procedures and methods to show compliance before the medical equipment is released. By following the specifications of BS EN ISO 10993, organizations can reduce biological and chemical hazards, and implement best practice safety measures. Additional background information, with guidance and a flowchart to demonstrate how to use this standard, is also included.

How does it work?

BS EN ISO 10993 first categorises the medical equipment before looking at the allowable limits and determination of EO and ECH residuals. It explains factors that should be taken into account when releasing products and defines the evaluation of gas chromatograms. Other topics include solvent extraction methods, aqueous extraction methods and the ideal testing conditions.

Who should buy it?

  • Hospitals
  • Health care centres
  • Professionals responsible for the sterilisation of medical equipment
  • Regulatory bodies
  • Inspectors

Why BSI?

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Standard NumberBS EN ISO 10993-7:2008
TitleBiological evaluation of medical devices. Ethylene oxide sterilization residuals
StatusCurrent, Work in hand
Publication Date31 December 2008
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)ISO 10993-10, ISO 10993-12, ISO 10993-17:2002, ISO 10993-1, ISO 10993-3
Informative References(Provided for Information)AAMI ST30-1989, ASTM E691-05, 93/42/EEC, AAMI GVR-1987, AAMI ST29-1988, ISO 11135-1:2007, 90/385/EEC
ReplacesBS EN ISO 10993-7:1996
International RelationshipsISO 10993-7:2008/Cor 1:2009,EN ISO 10993-7:2008/AC:2009
Amended ByCorrigendum, July 2010
DescriptorsBiological hazards, Testing conditions, Determination of content, Sterile equipment, Calibration, Medical equipment, Formulae (mathematics), Sampling methods, Sterilization (hygiene), Gas chromatography, Aqueous extraction methods, Factor of safety, Safety measures, Precision, Solvent extraction methods, Ethylene oxide, Chemical hazards, Conformity, Dose (drug), Biological analysis and testing, Standard solutions, Temperature, Extraction methods of analysis, Chemical analysis and testing
Title in FrenchÉvaluation biologique des dispositifs médicaux. Résidus de stérilisation à l'oxyde d'éthylène
Title in GermanBiologische Beurteilung von Medizinprodukten. Ethylenoxid-Sterilisationsrückstände
ISBN978 0 580 70145 0
File Size2.663 MB

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