Delivery of reusable medical devices and sterilisation of reusable medical devices

ANNEX I - PRINCIPLES AND GENERAL GUIDELINES

ANNEX IIa - GOOD PRACTICES FOR THE STERILISATION OF REUSABLE MEDICAL DEVICES

ANNEX IIb - Good practices for the maintenance of heat sensitive
flexible endoscopic instruments and for the prevention of infections

ANNEX III - PIC/S GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS

==> Annexes to NOTIFICATION 2019/0074/B - 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.