SS ISO 20857:2018
[Current]
Sterilisation of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilisation process for medical devices
...17
health care product(s)
medical device(s), including in vitro diagnostic medical device(s), or medicinal product(s),
including biopharmaceutical(s)
[ISO/TS 11139:2006, definition 2...
...trument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator,
software, material or other related article intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specifi...
...tration of the effectiveness of the sterilization
process in inactivating all types of microorganisms, identified in this definition, for development, validation
and/or routine control of the sterilization process...