From the 15th June 1998, each medical device placed on the market has to comply with directive No. 93/42/EEC, and must therefore be officially certified and bear the relevant CE Medical Devices mark.

An RO unit intended for the purpose of Haemodialysis is considered a medical device. Does anybody know whether this also applies to a water distribution loop used to circulate RO water is used for Haemodialysis?

I am not absolutely positive on this topic, but I believe the RO system are considered medical devices because they are actually manufacturing a medical product (ie. our water used to make dialysate). The piping and distribution system is a delivery system therefore I do not believe it needs certifications.

I'm not absolutely sure but I think it may be considered as an accessory to a Medical device i.e. an necessary part of the process involved with the device.

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If your in Europe,you may be right...In the only non third world country (USA)no CE mark is required.


TE]Originally posted by Mark Gatt:
From the 15th June 1998, each medical device placed on the market has to comply with directive No. 93/42/EEC, and must therefore be officially certified and bear the relevant CE Medical Devices mark.

An RO unit intended for the purpose of Haemodialysis is considered a medical device. Does anybody know whether this also applies to a water distribution loop used to circulate RO water is used for Haemodialysis?

[/QUOTE]