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 France
In France, there is a specific regulatory and prescriptive framework for biohazardous waste management:
- Articles R. 1335-1 to R. 1335-8 of the Public Health Code.
- Order of September 7, 1999 relating to the storage methods of infectious waste and anatomical parts.
- Order of September 7, 1999 relating to the control of disposal systems for infectious waste and anatomical parts.
- Order of November 24, 2003, as amended, relating to the packaging of infectious waste and anatomical parts of human origin.
- Decree 2011-763 of June 28, 2011 relating to the management of perforating infectious waste produced by patients undergoing self-treatment.
- Standards relating to the packaging of healthcare waste: boxes and mini collectors for perforating waste (standard NF X 30-500), plastic drums and jerry cans for infectious waste (standard NF X 30-505), bags for soft healthcare waste with infectious risks (standard NF X 30-501).
- Decree no. 2010-1263 of October 22, 2010 relating to the disposal of infectious waste produced by patients undergoing self-treatment.
- Infectious waste directly on site.
- Standard NF X30-503-1 February 2016 – Waste from healthcare activities – Reduction of microbiological and mechanical risks of healthcare waste with infectious risks and assimilated by disinfection pre-treatment equipment, which details the design and testing specifications of equipment for pre-treatment of infectious waste alternative to incineration, before they are placed on the market.
- Articles R. 1335-1 to R. 1335-8 of the Public Health Code
- Decree no. 2016-1590 of November 24, 2016 amending the Public Health Code and relating to waste assimilated to waste from healthcare activities with infectious risks and to disinfection pre-treatment equipment published in the Official Journal of November 26, 2016 (JORF no. 275), which makes it mandatory for disinfection pre-treatment equipment to comply with the latest version of standard NFX 30-503-1 (February 2016), for better safety of infectious waste pre-treatment facilities.
- The decree of April 20, 2017 relating to the pre-treatment by disinfection of healthcare waste with infectious risks and similar activities published in the Official Journal of April 23, 2017 (JORF No. 96), which simplifies the formalities for the on-site pre-treatment of DASRI by alternative methods to incineration (no longer requiring a prefectoral authorization) and details the procedures for monitoring these facilities for the safety of personnel and the environment.
Will all these evolutions enable the development of on-site pre-treatment technologies for infectious waste, so that soon there will no longer be any infectious risk waste on the road?
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