Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
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1 Scope
This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of EN 566 specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
Product Details
Descriptors
Marking
Sterile equipment
Medical instruments
Quality assurance
Quality control
Sterilization (hygiene)
Medical equipment
Microorganisms
ICS Codes
11.080.01 Sterilization and disinfection in general