Title: Robotic Systems and Surgical Applications:Standards and Certification
Author: prof. Alberto Rovetta N. AF-2
References:

MEDDEV: Guidelines to the classification of medical devices , 10/93

Objectives
The use of robotic equipment in medical environments, especially in operating rooms is frequent. Such equipment is used both to support the surgeon activity and to substitute the surgeon operation in different application. Each equipment must be certified by means of a notified body, in order to be able to operate in such environment. In order to do that, it is necessary to design and to build the robotic system according to specific standard which specify the design of such equipment

Contents

  • Any kind of European standard existing;
  • analyzing the existing European standard about the medical devices, with particular attention to the robotic system to be used to make the prostate biopsy and the sample of the bone marrow. The scope is to give to the robotic system customer an overview about the set of standard needed for the certification of the robotic system;
  • robotic system description;
  • discrepancies between the robot system constructive characteristics and the standard requirements, by means of the comparison between the constructive robotic system features and the standard requirements for a medical equipment built in such a way;
  • use of an industrial robot with six degrees of freedom, which presents suitable technical characteristics
  • EC Directive 93/42/CEE: The primary reference for medical devices within Europe is the European Community Directive 93/42/CEE ‘Medical Devices’ issued on 14-06-1993 (MDD). Within Member States all medical devices on the market shall comply with MDD since 14-06-1998.
  • CE certification and marking: The CE certification and marking for medical devices of any class, excluding some types of class I devices, can be obtained only through a Notified Body that are designated in each member State by the competent authorities and have specific check and verification tasks during the certification procedure.
  • classification of the robot;
  • a very important concept is the intended use, because depending on it the device is classified and therefore the whole certification procedure is defined. The exact identification of the product class is fundamental to find out the appropriate certification procedure. The surgical robot is a medical device and it can be intended to be used for treatment of a disease (for biopsy) or for replacement of a physiological process.

Results
Procedures to obtain the conformity assessment:
Alternative procedures to obtain the CE conformity, depending on the device class. For a device of class IIb the following alternative procedures are applicable, indicated by the Annex where they are described. For those parts of the robotic equipment that are not regulated by any standard it is necessary to make opportune tests in order to satisfy the requirements of the Annex I of the EC Directive 93/42/CEE and then to have the CE certification.
The risk analysis is to be used for identifying the hazards that the device can generate during its use and therefore for taking the appropriate measures to minimize the risks.
The robotic equipment, constituted from all its parts connected among them so they perform the intended use of the robotic equipment itself, must satisfy the requirements of the Annex I of the EC Directive 93/42/CEE in order to have the CE certification. The satisfaction of such requirements is obtained by means of opportune tests.
In order to design the robotic equipment that is able to satisfy the requirements above mentioned it needs to carry out a risk analysis related to the robotic equipment.

Future possible developments
a) Analyzing the existing European standard about the robotic equipment in order to identify the standard tests useful to evaluate the satisfaction of the requirements of the EC Directive 93/42/CEE
b) Carrying out the risk analysis together with the application of the European standard about the robotic equipment in order to evaluate its technical characteristics, so to satisfy the requirements of the EC Directive 93/42/CEE
c) The point a) together with b) allow to design and test the robotic equipment in order to have the CE certification (by means of the satisfaction of the requirements of the EC Directive 93/42/CEE)