DIN EN ISO 13485 certification according to KRINKO/BfArM

The Robert Koch Institute regularly publishes updated guidelines which are developed by the Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute (RKI). These form the basis for measures to prevent nosocomial infections (hospital infections) and combat antibiotic resistance.

The KRINKO recommendations are based on the German Protection against Infection Act (IfSG) Section 23.1 and are therefore regulatory in nature. This is particularly true of the KRINKO recommendation regarding hygiene requirements when reprocessing medical devices (Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten) as published in the Federal Health Bulletin (Bundesgesundheitsbl 2012 - 55:1244-1310 / DOI 10.1007/500103-012-1548-6) © Springer-Verlag 2012), as these were taken up into Section 8 of the German Medical Device Operators Ordinance (Medizinprodukte – Betreiberverordnung – MPBetreibV). This means that the KRINKO recommendations directly apply to the operation and use of medical devices, including necessary reprocessing.

Certification of quality management for reprocessing of medical devices is above all suitable for institutions which operate a reprocessing unit for medical devices.

The risk classification of medical devices provides for three (3) categories which are based on the risk of infection transmission via a device.

Devices are categorized as uncritical, semi-critical or critical. Critical medical devices place the most stringent demands on reprocessing, as they are intended for use in invasive procedures and therefore come into direct contact with body tissue or with bodily fluids such as blood. Instruments in the critical C category present the highest risk.