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Standards and tests

STERIPLUS™ 40 has CE mark and was designed specially to respond to one of the strictest standards for waste decontamination equipment (French standard NF X 30-503).

Tests were performed by Dr. Marie-Florence Gireaudot-Liepmann from the independent lab Biorisk Expertise (www.biorisk.fr),former chief of service at the Institut Pasteur (Lille) and expert in national committees of organizations such as AFNOR, SFM (French Microbiology Society) and SF2H (French Society for Hospital Hygiene).

The sterilization cycle has been validated according to international standards NF EN 554 and EN ISO 17665-1.

The reports for the tests performed are available on request.

Regulation in Francenormes

In France, there is a specific regulatory and prescriptive framework for biohazardous waste management:

  • Articles R. 1335-1 to R. 1335-8 of the French Public Health Code.
  • Ruling of September 7, 1999 regarding the conditions of storage for biohazardous waste and anatomical parts.
  • Ruling of September 7, 1999 regarding the control of disposal procedures for biohazardous waste and anatomical parts.
  • Ruling of November 24, 2003 regarding the packaging of biohazardous waste and human anatomical parts.
  • Decree 2011-763 of June 28, 2011, regarding the management of biohazardous waste sharps generated by self-treatment patients.
  • Standards regarding packaging of medical waste: Boxes and small collectors for sharps (standard NF X 30-500); Plastic drum and jerry cans for biohazardous waste (standard NF X 30-505); Bags for soft biohazardous waste (standard NF X 30-501).
  • Decree 2010-1263 of October 22, 2010, regarding the disposal of biohazardous waste generated by self-treatment patients.
  • Tesalys is proud to announce the acquisition of the standard NF X30-503-1 February 2016 – Waste of care activities – Reduction of the microbiological and mechanical risks of the waste of care activities with infectious risks and assimilated by the devices of pretreatment by disinfection for the SteriplusTM80, delivered by the National Laboratory of Metrology and Tests.
    This standard details the design and testing specifications of DASRI pretreatment devices that are alternative to incineration before they are placed on the market.

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