ISO/IEC JWG for medical robot safety standards

After the Medical Robotics workshop at PoliMi, the 4th meeting of the medical robot safety study group was held.

Just as before, I took part in the ISO/TC 184/SC 2/JWG 9 work as a national deleguate. This is the standing joint committee of the International Standardization Organization (ISO) and the International Electrotechnical Commission (IEC) aiming to develop a new collateral standard for medical robot safety. The rest stands for:

• TC 184: Technical Committee on Automation Systems and Integration
• SC 2: Sub-Committee on Robots and Robotic Devices
• JWG 9: Joint Work Group on Standard for Medical Robots (with WG 7 & IEC/SC 62A).

Most of the discussions were about the identification of additional risks and hazards the Degree of Autonomy (DoA) introduces in the OR. (DoA being defined along the ALFUS workgroup's concept.) It is essential to define the risks in the future standard  to provide strategies for risk mitigation. For personal care robots, the proposed safety requirements (created by the ISO TC 184/ SC2 / JWG7) are based on machine safety guidelines (defined by the EC’s Machinery Directive in Europe) whereas medical robots’ standardization guidelines (are defined by the EC’s Medical Device Directive in Europe) need basic safety and essential performance requirements—yet to be formulated. The key difference is that some analysis of risk–benefit posed to the patient needs to be carried out in medical applications. Especially with invasive systems (surgical robots), this can be a major factor. One example could be the delicate and accurate dissection and handling of advanced stage brain tumors.

The next meeting will be held in Seoul, Korea:

• ISO TC 184/SC 2/WG 7 (Personal care safety), Oct. 15(Mon) – 19(Fri)
• ISO TC 184/SC 2 and IEC SC 62A JWG 9 (Medical electrical equipment and systems using robotic technology), Oct. 22(Mon) – 24(Wed)
• ISO TC 184/SC 2/WG 8 (Service robots), Oct. 22(Mon) – 23(Tue) AM
• ISO TC 184/SC 2/WG 8/Study Group on Modularity, Oct. 23(Tue) PM – 24(Wed)
• ISO TC 184/SC 2/WG 1 (Vocabulary and characteristics), Oct. 24(Wed).

If you are interested joining the meetings, contact you national ISO liasion officer.