2019/0074/B
EC/EFTA
BE Belgien
  • S10S - Medizinprodukte
2019-05-21
2019-02-26

Delivery of reusable medical devices and sterilisation of reusable medical devices

Royal Decree on the preparation and delivery of medicines and the treatment and distribution of medical devices in health care establishments

The purpose of the draft is to lay down rules concerning sterilisation in hospitals, namely:

- The distribution and delivery of medicines

- The distribution and provision of medical devices

- The regulation of the sterilisation of reusable medical devices

Annexes IIa and IIb comprise technical standards which must be met by the equipment used for sterilisation:

IIa: ISO 14644-1; EN ISO 13485; EN ISO 15883; EN ISO 868-1 to 8; EN
ISO 11607 – 1; EN ISO 11607 – 2; ISO TS 16775; EN 867-1; EN ISO 14937;
EN 1422 (environment); EN 285; EN 17665 (554); EN 11140-3; EN 867-4; EN
13060; EN ISO 17665; ISO 16664; ISO 11138-1; ISO 11140-1; EN ISO 17664;
ISO 11228-1.

IIb: French Standard NF S98-030; EN ISO 15883.