Sterile Devices
Overview
Class Is devices are medical devices that are supplied in a sterile condition by the manufacturer. Unlike standard Class I devices, Class Is requires notified body involvement specifically for the sterility aspects of the conformity assessment procedure, even though they remain Class I overall.
NB Involvement for Class Is
Under MedDO Annex IV (for the sterility aspects), the manufacturer must engage an NB to assess:
- The sterilisation process validation
- The sterile barrier system
- Transportation and storage maintaining sterility
The NB issues a certificate covering only the sterility aspects. The overall DoC remains the manufacturer's.
Key Standards
- EN ISO 11135 — Sterilisation of health-care products: ethylene oxide
- EN ISO 11137 — Sterilisation by radiation
- EN ISO 11607 — Packaging for terminally sterilised medical devices
- ISO 17665 — Sterilisation by moist heat (steam)
Official Sources
Disclaimer
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