Dear,
As for CE-marking, it is not sufficient to say "it's CE-marked". It must state CE-marked to WHAT. There are all sorts of different CE marking eg anything electric must be CE-marked as electrically safe: this does not mean that a medical product is CE-marked for medical use, just that it is safe from an electric stand point.
It must be CE-marked to the Medical devices Directive (93/42/ECC), or other medical directive depending on device use.
The CE-mark is a declaration BY THE MANUFACTURER that the product meets appropriate provisions of relevant legislation relating to safety. Once CE-marked, the product can be freely marked anywhere in the EU without further control.
Items that do not need CE-marking include devices undergoing clinical investigation and custom made devices.
As for STERIS EO canisters: they are CE-marked. We have 3 versions: one for Domestic use, one for Canadian use and meeting EC regulations (that is CE-marked).
Both STERIS EO Steriliser and consumables are fully CE-marked to the necessary directives.
Best regards,
Christine Zeiss
STERIS limited
Healthcare Division
The Stable Block
Cornbury Park, Charlbury,
Oxfordshire, OX7 3 EH
tel: 01608 811822
fax: 01608 811854
NOTE: Chapter 1, Article 1 of the Medical Device Directive defines a "medical device". (Wim Renders)
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