Determination of sterilization residues by ETO according to ISO 10993-7

Industrials of the Health sector, you wish to verify the conformity of your devices to ISO 10993-7

What is ISO 10993-7?

Ethylene oxide and ethylene chlorate sterilization are widely used sterilization methods for their microbiological effectiveness. These sterilizations are used in particular for medical devices and pharmaceutical products that cannot withstand traditional high-temperature steam sterilization (such as single-use medical devices for example).

Thus, the ISO 10993-7 standard “Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residues” is an international regulation related to the sterilization of finished products. It allows the determination of residues from ethylene oxide and ethylene chlorate sterilization of medical devices and verifies the maximum elimination of residues of these chemicals.

Why measure ethylene oxide sterilization residues according to ISO 10993-7?

ISO 10993-7 specifies the procedures for the determination of ethylene oxide and ethylene hydrochloride and the allowable limits (expressed as average daily patient dose (mg/day)) of these residues per device.

In addition, the ISO 10993-7 standard specifies the procedures and criteria for product release. As a result, three categories of exposure based on the duration of contact have been defined:

  • <24h, for limited contact,
  • <30 days, for prolonged contact,
  • > 30 days, for permanent contact.

Thus, in order to optimize your products according to the ISO 10993-7 standard, the support of a specialized laboratory is a considerable asset

FILAB supports you in the determination of ethylene oxide according to ISO 10993-7

As an expert in the field of trace organic substance analysis, FILAB assists you at every stage of the validation of your industrial processes, particularly sterilization processes.

Our specialists have developed specific methods for the determination of Ethylene Oxide and Ethylene Hydrochloride on medical devices, using exhaustive extraction to recover all residues.  The assay is performed by HS/GCMS (Headspace Injection followed by Gas Chromatography coupled to a Mass Spectrometer).

Nos spécialistes ont développé les méthodes de dosages spécifiques de l’Oxyde d’Ethylène et du Chlorhydrate d’Ethylène sur Dispositifs Médicaux, par extraction exhaustive afin de récupérer la totalité des résidus.  Le dosage est réalisé par HS/GCMS (Injection par Espace de Tête suivi d’une Chromatographie en phase Gazeuse couplée à un Spectromètre de Masse).

Did you know that?

On 10/09/2015, a health policy decision setting specific conditions for the marketing and distribution of certain medical devices sterilized with ethylene oxide was issued by the ANSM (National Agency for Health and Medicines): http://ansm.sante.fr/S-informer/Points-d-information-Points-d-information/Dispositifs-medicaux-utilises-en-neonatalogie-et-en-pediatrie-sterilises-a-l-oxyde-d-ethylene-Mise-en-aeuvre-de-la-norme-NF-EN-ISO-10993-7-Point-d-Information

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Thank you !

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