ACROBOT GPS

Risk Assessment

Ferdinando Milella (PhD in Electrical Engineering at DEE Politecnico di Bari - Italy (96) ) from September 2002 senior consultant at

(The Advanced Manufacturing Technology Research Institute)

http://www.amtri.co.uk milella@amtri.co.uk

AMTRI is a UK government approved body for checking quality system to ISO 9000 and ISO 14001

GPS
Gross Positioning System

PROJECT REQUIREMENTS
Very high stiffness High accuracy (NOT repeatability) Very low max. velocities + Highly integrated mechatronic structure (i.e. mechanical structure and electrical/electronic devices all coexisting in the same cabinet) + CE marking

Why CE marking?
The purpose of CE Marking is to make it easy to supply goods throughout the European Union. There is a legal duty on machinery manufacturers and suppliers to CE mark their equipment before it is put into use. The CE mark signifies that the machinery complies with all relevant directives and standards for machinery as dictated by EU, plus Iceland, Liechtenstein and Norway. To comply with this legislation, all machinery has to meet the Essential Health and Safety Requirements (EHSRs) contained in the directives.

How to CE mark?
Most machines can be CE marked by the manufacturer (self-certification) but to comply with the EHSRs, a technical file of specified data must be provided to substantiate the certification. Notified Bodies are companies or institutions qualified to examine machinery files for clients. This ensures that manufacturers claims can be substantiated.

WHY DO WE NEED STANDARDS?

What if railway tracks were all different sizes? What if if one type of card only fitted one type of cash machine? Standards mean you would be sure that: the design drawings were done in a certain way, so you (or any other engineer) would be able to read them correctly the parts you ordered were made to the right size the suppliers were sending you safe parts because standard ways of testing would have been used.
Standards interpret the safety objectives and also provide a technical route to compliance.

 The Medical Device Directive Directive 93/42/EEC

(and COLLATERAL STANDARDS)

Applicable since June 1993 and mandatory since June 1998

PROBLEM: there are no specific directives concerning the use of mechatronic systems as medical devices

The Medical Device Directive (MDD) is not applicable to the following products:
In vitro diagnostics (covered by Directive 98/79/EEC) Active Implantable Medical Devices (covered by Directive 90/385/EEC) Medicinal Products (covered by Directive 65/65/EEC) Cosmetic Products (covered by Directive 76/768/EEC) Devices intended for use in clinical investigation and custom-made medical devices must satisfy the requirements of the Medical Device Directive but do not need to affix the CE Marking.

What can we do?

In absence of directives the Manufacturer is entitled to comply by using any appropriate specifications that may demonstrate conformity with the safety objectives[]

RISK ANALYSIS!!

Analysis and assessment of risks

(EEN 1441) 1) 2) 3) 4) 5) 6) 7) 8) 9) Identify the product and describe the intended use Identify characteristics which could affect safety Identify possible hazards Estimate the risk for each hazard for both normal conditions and use in case of failure Determine whether the risk is acceptable Determine whether the risk can be reduced If a risk is reduced (for example by a change in design), determine if other hazards have been generated Evaluate all identified hazards Determine if the device safety is adequate

Risk Quantification - 1
(EN 1050)
Severity 1 2 3 Frequency 1 2 Probability 0 1 2 3 Avoidance 1 2 slight (normally reversible) injury or damage to health may require first aid serious injury or damage to health requiring reporting under RIDDOR death seldom to quite often frequent to continuous extremely low - it can be assumed that occurrence may not be experienced low - unlikely to occur in the course of a year medium - likely to occur once a year high - likely to occur frequently possible under specific conditions scarcely possible

Risk Quantification - 2
Risk Assessment Graph SEV FREQUENCY PROBABILITY

0 1 1 2 2 1 2 3 0 1 3 5 7 1 0 2 4 6 8 2 1 3 5 7 9 1

1 2 4 6 8 10 2 3 5 7 9

2 4 6 8 10 5 7 9

3 6 8 10

11 12 13 14 1 2

11 12 1 2

AVOIDANCE

0-2 5-7 11-14

very low risk; 3-4 medium risk; 8-10 extremely high risk

low risk; high risk;

EXAMPLE OF RISK ASSESSMENT TABLE

ID

Hazar d IDs

Hazard

S F P A R

Protection Measures

S F P A R

Comments

System Performance 1 1 Description of situations involving risks without protection measures 1 1 3 1 7 Description of situations involving risks with protection measures 1 1 2 1 5 Any comment useful to explain how the protection measures work.

R 7 for each possible risk situation!!

Conclusions
Lack of standards involves: Higher designer and development costs for Risk Assessments Unless probabilistic risk assessment techniques (expensive!!) are used risk estimation is basically subjective uncertainties in achieving the required level of safety

A little advise for the future:

More co-operation and more exchange of information among Companies and Research Institutes in order to create a Safety Culture in Surgical Robotics