Please see the newsletter from AMDEA and note the comments regarding the Product Regulation and Metrology Bill (IVD’s maybe in scope, and many off the shelf accessories used with IVDs will definitely be in scope). Lithium batteries is one such device that will be in scope, but which is not specifically identified in the present legislation framework.
Note also the new IEC standard proposal for a standard regarding electrical devices connected to mains water. Most large IVD instruments, are not directly connected to mains water, but via a laboratory grade deionised water system. The deionised water systems themselves will require such a water gap/back flow inhibitor system installing in their mains water supply.
