2019/0151/F
EC/EFTA
FR France
  • S00S - HEALTH, MEDICAL EQUIPMENT
2019-07-03
2019-04-09

Cardboard boxes with plastic bags (combined packaging) for clinical waste with infection risks (DASRI [déchets d’activités de soins à risques infectieux]) that is solid or soft

Order amending the order of 24 November 2003 on the packaging of clinical waste with infection risks and similar waste and anatomical parts of human origin

In accordance with Article article R.1335-6 of the French Public Health Code, the Order of 24 November 2003 defines the standards with which packaging of clinical waste with infection risks comply. 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 objective of this draft amending Order is to update the reference to standard NF X 30-507 on cardboard boxes with plastic bags (combined packaging) for DASRI that is solid or soft referred to in Article 4 of the Order of 24 November 2003, the new version of which was published in July 2018. 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 the cardboard boxes with inner plastic bags must meet (Annex 1 of the draft Order) and establishes a presumption of conformity with standard NF X 30-507: 2018. It also provides productions methods for tests designed to verify compliance with these requirements.