We certified Neuron-Spectrum-5, Neuron-Spectrum-5/S, Neuron-Spectrum-4/EPM, Neuron-Spectrum-4/EPM/S, Neuro-MEP, Neuro-ERG, Neuro-MEP-5 и Neuro-MEP-5/2 for compliance to IIb class requirements according to Annex II of Council Directive 93/42/EEC of 14 June 1993 “Concerning Medical Devices”.
Annex I “ESSENTIAL REQUIREMENTS” of this directive states that “The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.”.
Medical devices are divided into safety classes depending on risk hazard. Each medical item can be related to only one class. The degree of potential risk rises with the class number increase (I, IIa, IIb and III). Devices with moderate degree of individual risk and (or) low degree of risk for social health care and environment fall within Class II. It in turn is divided into IIa and IIb classes with moderate and high risk degree correspondingly.
According to classification the devices fall within IIb class “if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient..
Thus, this certificate for compliance to IIb class requirements is an obligatory condition for device use in operating rooms and intensive care units on the territory of European Community.
For equipment manufacturer it results in considerably tightened quality control of development processes.
Recent audit of QMS revealed that the development processes of our company correspond to these high standards and now Neurosoft equipment can be used in operating rooms and special care wards of medical establishments of European Community.