Medical Device Sterilization Validation Services
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作者:admin
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Date: 2025-06-26
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Sterilization is a process to make products free from viable microorganisms. Some semi - critical and all critical medical devices should be sterilized before next use. Reference standards include FDA guidance, AAMI TIR 12: 2020, ISO 17664 - 1: 2021 and others. Sterilization efficacy test methods involve microbiological method and various sterilization types like moist heat, EO, hydrogen peroxide, dry heat and liquid chemical sterilization. Thermal distribution in moist heat sterilization (gravity replacement, pulsating vacuum) has a test duration of 4 - 6 weeks and requires at least 8 test articles.
Sterilization is a validated process used to render product free from viable microorganisms. Depending on the intended use, some semi-critical and all critical medical devices should be sterilized before next use.
Reference standard:
FDA Guidance for industry and Food and Drug Administration Staff Reprocessing medical devices in healthcare setting: Validation Methods and Labeling
AAMI TIR 12: 2020
ISO 17664-1: 2021
ISO 17665-1: 2006
ISO 14937:2009
ISO 11138-1:2017
ASTM E1766-2015
YY/T 0802-2020
GB 18278.1-2015
WS/T 367-2012
WS 310.1-2016
WS 310.2-2016
WS 310.3-2016
Sterilization efficacy test methods |
Microbiological method | Moist heat (steam) sterilization, EO sterilization, Hydrogen peroxide sterilization, Dry heat sterilization, Liquid chemical sterilization etc. |
Thermal distribution | Moist heat sterilization (gravity replacement, pulsatingvacuum) |
Test duration: 4~6 weeks
Need at least 8 pcs test articles
