Welcome and Registration
MICROBIOLOGICAL QUALITY cont..
ISO 11737-1 Bioburden estimation Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements
MICROBIAL INACTIVATION KINETICS
Implications Sterilization of medical devices – Requirements for a terminally-sterilized device to be labelled “sterile”
Pharmacopoeia 'Test for sterility'
'Test of sterility' Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process
BIOLOGICAL and CHEMICAL INDICATORS
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
The nature of ionising radiation and the measurement of dose (gamma, electrons, X-rays)
RADIATION STERILIZATION cont..
RADIATION STERILIZATION (IQ, OQ and PQ)
RADIATION STERILIZATION (IQ, OQ and PQ) cont..
EN ISO 14644 –x:1999 Clean rooms and associated controlled environments
The future direction of sterilization standards.
ISO 14937 General Requirements for Sterilization of Medical Devices
AUDITING TO THE STANDARDS / AUDIT PLANNING
ISO 13485:2003 Quality management systems – Medical devices – Requirements for regulatory compliance
REVIEW OF COURSE
Anette Sjögren & Poul Schmidt-Andersen
Individual revision / Preparation for exam