2020/0147/F
EC/EFTA
FR France
  • S00S - HEALTH, MEDICAL EQUIPMENT
2020-06-24
2020-03-24

Plastic drums and canisters, boxes and pocket collectors for infectious clinical sharps waste.

Draft Order amending the Order of 24 November 2003 on packaging of infectious clinical and similar waste and anatomical parts of human origin

In accordance with Article R. 1335-6 of the French Public Health Code, the Order of 24 November 2003 sets out the requirements for the packaging of infectious clinical and similar waste (DASRI). These standards are aimed at ensuring the safety of packaging and thus contribute to the prevention of accidental exposure to blood by healthcare professionals and those in charge of waste collection. They have been applied by manufacturers marketing this packaging on national territory since 2003.

The draft Order updates the normative reference ISO 23907, published by ISO in 2019, concerning on the one hand plastic drums and canisters and on the other hand boxes and pocket collectors for sharps waste, cited in Articles 5 and 6 of the above-mentioned Order of 24 November 2003. Moreover, in accordance with Decree No 2009-697 of 16 June 2009 on standardisation, which provides that adherence to the standards is voluntary, the draft Order defines the design and marking requirements which cardboard boxes with inner plastic bags must meet (Annex 1 to the draft Order) and establishes a presumption of conformity with standard ISO 23907: 2019. It also sets out production methods for tests designed to verify compliance with these requirements.