STANDARDS

The BEAI would like to thank Mr. C. O'Neill who has taken time to write this and previous articles on behalf of the committee of the Electro-technical Council of Ireland which deals with electromedical equipment, that is TC10. The BEAI is grateful for the working relationship with ETCI - TC10, and hope to continue to publish similar material and to develop communicative links with other standards bodies.

The development and updating of standards is an ongoing process. Since the publication in 1977 of IEC 60 1 - 1, Medical electrical equipment Part 1: General requirements for safety, which sets out the requirements for the safety of Medical electrical equipment, the continuing work of IEC Technical Committee No. 62 led to the publication of the second edition in 1988. Since 1988 two amendments have been added, one in 1991 and one in 1995 and in addition four collateral standards. The first collateral, numbered 601-1-1-2 the requirements and tests for Electromagnetic Compatibility, 601-1-3 requirements for radiation protection in diagnostic XRay equipment and 601-1-4 is a standard for devices which uses software but is not a software standard. To date approximately fifty Part 2: Particular Standards have been published. These specify requirements in the General Standard for particular types of medical electrical equipment e.g. 601-2-25 (1993) Part 2: Particular requirements for the safety of electrocardiographs. The purpose of this series of standards is to assist manufacturers in the production of safe medical electrical equipment and for use by test houses and regulatory authorities when assessing compliance with the requirements.

To take account of the rapid growth and advances in technology and the expansion in the scope of application, IEC sub-committee No. 62A realised that the General Standard 601-1 should be updated and improved. Following a positive voting result by the national committees of the IEC the decision to proceed with the development of the third edition of 601-1 was taken. It is proposed that the title of the new document will be IEC-601 Medical electrical equipment - Part 1: General requirements for safety and essential performance. Whilst it is also proposed that only the minimum necessary changes will be made, with the scope remaining the same, the new edition will consist of fifteen in contrast with the second edition which consists of ten parts. In the original proposal it was suggested that the new documentation be re numbered to become the IEC 2000 series as it will be launched sometime after the year 2000.

The proposal for the new work outlined the possible format to be followed but it is to be emphasised that no decision on the content, format or numbering will be taken until after the publication of the irst committee draft.

It is proposed that the third edition should be based on the philosophy of IEC 513 (1994). The first edition of IEC 513 was published in 1976 and the revised second edition in 1984. The first edition formed the basis for developing the first and second editions of IEC 601-1 with its series of collateral and particular standards. It is now replaced by the second edition which contains two major changes. The concept of 'safety' has been broadened from the basic safety considerations in the first and second editions of 601 -1 to include essential performance matters (e.g. the accuracy 1 of physiological monitoring equipment).

Secondly it specifies minimum safety requirements in assessing the safety of new technologies such as programmable electronic systems.

Based on this it is proposed that the third edition will address new items not covered in the second edition such as risk management, environmental protection and essential performance. Under the heading of environmental protection it is proposed to set out manufacturers responsibilities for environmental protection in regard to the disposal of equipment by-products and disposable supplies. There will be a section to deal with protection against biological hazards from non-ionising radiation, such as microwave and light radiation including lasers, UV, IR radiation and acoustic energy including ultrasound. It is also proposed to set out requirements for programmable electronics and software. The existing sections of the second editions will be revised and updated. This new work will require close liaisons with the technical committees and working groups of IEC, ISO, CENELEC and CEN and the setting up of new working groups. The first committee draft is expected to be ready in about two years and the final document in about eight years. Some changes from the original proposals can be expected and in its final form it may differ from the outline given here, but the new document should mark another step forward in the continuing efforts to make medical electrical equipment and its use more safe.

C.O'Neill, ETCI TC10.