|Company:||Matrix Information Service|
|City, State, Zip:||Mountain View. CA|
|Project Name:||Compliance Testing (UL/IEC) for UV Cabinet|
|Expertise:||Requires Multiple Disciplines|
|Description:||I have a client who is developing a cabinet unit to disinfect hospital equipment using UV-C. I'm developing documentation for the unit, but he also needs help with compliance to the following standards and tests. |
I would like to hear from consultants who can help with part or all of the following issues. Once we discuss it, if it seems a good fit then I'll just pass you directly to my client and get out of the deal.
IEC 61010+IEC 61010-2-40
Additionally, the following tests have to be performed:
(i) The chamber's ability to control the UV radiation dose during operation.
(ii) Evidence that the equipment intended to be processed is UV compatible.
(iii) Validation of the cleaning and disinfection procedures.
(iv) The ability of the device to continue to perform to all specification after cleaning and disinfection.
(vi) Whether the device generates ozone (if so, 21 CFR 801.415, Maximum acceptable level of ozone, applies).
(2) Appropriate software verification, validation, and hazard analysis must be performed.
(3) Appropriate analysis and/or testing must validate electrical safety, mechanical safety, and electromagnetic compatibility of the device in its intended use environment.
(4) The labeling must include:
(i) UV hazard warning labels.
(ii) Explanation of all displays and/or labeling on user interface.
(iii) Explanation of device safety interlocks.
(iv) Explanation of all disinfection cycle signals, cautions and warnings.
|Date:||November 1, 2016|