Hello phicarre!
phicarre said:
...sterilisation within a hospital...
What is your intention/scope?
Do you want to establish a Quality Management System for the sterilization department of the hospital, or do you want to write SOPs for sterilization.
There are standards especially for sterilization (processes):
- EN 285 Sterilization - Steam sterilizers - Large sterilizers
- EN 550 Sterilization of medical devices - Validation and routine control of ethylene oxide sterilisation
- EN 552 Sterilization of medical devices - Validation and routine control of sterilisation by irradiation
- EN 554 Sterilization of medical devices - Validation and routine control of sterilisation by moist heat
- EN 556 Sterilization of medical devices - requirements for medical devices to be labelled sterile
- EN 867-2 Non-biological systems for use in sterilizers - Part 2 : process indicators (class A)
- EN 867-3 Non-biological systems for use in sterilizers - Part 3 : specification for class B indicators for use in the Bowie and Dick test
- EN 868-1 Packaging materials and systems for medical devices which are to be sterilized - Part 1 : general requirements and test methods
- EN 1174-1 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: requirements
- EN 1174-2 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: guidance
- EN 1174-3 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: guide to the methods for validation of microbiological techniques
- EN 1422 Sterilisers for medical purposes – ethylene oxide sterilisers – requirements and test methods
Maybe some of these standards are helful for you