Conclusions drawn from 9th ACOS safety workshop
As announced in the March 2009 e-tech, ACOS (the IEC Advisory Committee on Safety) held its ninth international workshop on the use of safety standards in a regulatory environment on 18-19 May 2009 in Milan, Italy, in the context of the celebrations for the 100th anniversary of the Italian National Committee of the IEC.
Vision of relationship between IEC standardizers and regulators shows a flowchart of
close dialogue and cooperation
Entitled "Risk assessment in IEC safety standardization work supporting regulations", the workshop was attended by some 100 participants from 15 countries and covered the following topics:
- the emerging global safety regulatory environment, with presentations from representatives of the European and national regulatory authorities;
- a brief overview of the IEC International Standards development process and the role of ACOS;
- safety-related risk assessment in the area of low-voltage equipment;
- practical applications of IEC Safety Standards from low-voltage equipment areas in the support of regulatory requirements;
- four breakout sessions set up around specific equipment to underline the possible ways of fulfilling the requirements presented on the first day.
The workshop was organized in response to Goal 1 of the IEC Masterplan 2006, which seeks closer cooperation between IEC standardizers and other stakeholders such as regulators. Safety is the subject of substantial regulation in many regions of the world.
The main conclusions included:
Risk assessment
During the workshop it was shown that risk assessment for low-voltage equipment is already widely used for many purposes by test houses, market inspectors, authorities for safety regulations etc. in China, the European Union, Japan, the United States of America and other regions. It was also stated that the use of a risk assessment guide for low-voltage equipment in the IEC would be beneficial for achieving harmonization and, in the long term, possibly for the harmonization of the working methods among different authorities.
Consistent requirements for products and Conformity Assessment
Technical requirements for a product and the requirements for its CA (Conformity Assessment) need to be consistent. Risk management in technical product safety considerations and CA procedures should be aligned and adapted to regulatory requirements. For instance, the ISO/IEC Draft International Standard 31010, Risk Management – Risk Assessment Techniques, should be aligned with ISO/IEC Guide 51.
Accident monitoring and assessment also duty of political authorities
Market monitoring and assessment of accidents are not only a duty of manufacturers but also of governments in order to allow for feedback to the IEC. Market surveillance by authorities is also necessary.
Increased transparency of consistent international risk assessment
Implementation of IEC International Standards at a national level is highly desirable. Consistent approaches for risk assessment and risk reduction among countries are necessary and improve transparency.
Inclusion of standards in regulatory measures
Regulation should indicate how standards can be helpful to fulfil legal requirements, such as in the New Approach in the European Union, and which additional measures are necessary in order to reflect the state of the art.
Common legal framework for low-voltage equipment and systematic risk assessment
The legal framework in different areas of technical products differs significantly. One example is that of LV (low-voltage) equipment versus medical products.
There should be a common approach to systematic risk assessment and risk reduction of LV equipment of whatever type. Basic IEC Safety Publications and Group Safety Publications and some of the IEC Horizontal Standards can be used effectively for reaching this objective.
Systematic risk assessment was successfully implemented in other fields such as machine safety a number of years ago.
Additional training required
The breakout sessions of the ACOS workshop specific to individual devices showed that implementing standardization is relatively easy provided that the experts involved have received sufficient training.
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