I am looking for some input for what approvals are mandatory, if any, for the following piece of equipment: The product is a hand held analyzer used in laboratories (IVD) which is powered by a non-rechargeable standard 9V battery. The unit incorporates a microprocessor and does not have any moving parts. The product is destined for the EU, USA, Canada, and Japan. Any advice, especially that which can be cited, would be greatly appreciated. Thanks.
J. Hinderlider [email protected] Courtesy of RCIC http://uc.com/compliance_engineering/
