The LNE Laboratory was recently certified by France's Health Ministry (by decree issued on April 28th 2017) to deliver compliance certificates for first-stage treatment devices to disinfect waste generated by healthcare activities involving infectious risks (French designation: DASRI). This honor stems from extensive collaboration between LNE and the Health Directorate (DGS) initiated in 2013 via a campaign undertaken in the French Standardization Commission entitled "Packaging of healthcare industry waste".
At that time and based on its expertise in tests conducted on packaging for cutting, slicing and perforating objects that carry infectious risks (needle boxes, mini-collectors and plastic barrels for syringes, blades, scalpels, etc.), LNE determined that the recently published ISO 23907:2012 international standard failed to provide a level of safety commensurate with the two mandatory national standards already on the books.
At the request of the National Health Directorate, LNE contributed to creating the new French Standard NF X30-511, published in 2015, that defined the set of safety requirements for the packaging of objects dedicated to cutting, slicing or perforating objects, as a complement to the ISO 23907 Standard.
Subsequent to this process, LNE was in 2015 appointed to head the French delegation tasked with monitoring the revision of Standard ISO 23907 on the ISO international standardization committee for the purpose of incorporating all missing safety requirements.
This standardization effort between the Health Directorate and LNE on packaging for healthcare industry waste carrying infectious risks (or DASRI) has brought us recognition by the Directorate as a body capable of issuing compliance certificates for first-stage treatment devices dedicated to disinfecting DASRI. In seeking to modernize the certification process by means of administrative streamlining, the Directorate has asked LNE to develop a benchmark that, once achieved by a manufacturer for a given product, triggers issuance of a compliance certificate (as per regulations). This type of first-stage treatment device offers an alternative to the specialized protocol for treating healthcare industry waste.
The above example illustrates the pivotal role played by LNE in dealings with public authorities, as a technical expert able to guarantee that the standards referenced in regulations display a minimum level of safety, as well as with industry as a certification body able to propose a regulatory product verification process that confirms the compliance of an industrial product with both a benchmark and a regulation.
This result could be derived thanks to LNE's multidisciplinary and complementary professions in the areas of product testing, standardization and certification, which have been merged to ensure a fully successful result.