IEC 60601-1.

Since the publication of IEC 60601-1, Medical Electrical Equipment Part 1. General requirements for safety, in 1977, the continuing work of IEC Technical Committee No.62 led to the publication of the second edition in 1988. Since 1988 the General Standard has been amended twice (1991 and 1995). In addition several collateral standards have been published. Collateral standards specify general requirements for safety that are applicable to:

1. A group of medical electrical equipment ( eg. radiological equipment)or
2. A specific characteristic of all medical electrical equipment that is not fully addressed in the general standard (eg. electromagnetic compatibility) for example, IEC 60601-1-1 specifies safety requirements for medical electrical systems, 60601-1-2 requirements and tests for electromagnetic compatibility (EMC.), 60601-1-3 requirements for radiation protection in diagnostic X-ray equipment and 60601-1-4 is a standard for devices which uses software but is not a software standard. New collateral standards are presently in preparation.

To date over fifty Part 2, Particular Standards, have been published. These standards specify requirements not covered in the General Standard for particular types of medical electrical equipment eg. IEC 60601-2-25 (1993) Part 2: Particular requirements for the safety of electrocardiographs. Where a Particular Standard is applicable it takes precedence over the General Standard.

The goal of the 60601 series is to improve safety in the use of medical electrical equipment by providing a body of standards that assist:

1. Manufacturers, in designing and assembling safe medical electrical equipment and systems,
2. Manufacturers, test houses, and regulatory authorities in assessing compliance with requirements set forth in the standard; and
3. Health care professionals in managing the risks associated with the use of these products.

The 60601 series has been widely accepted by the above as a tool for demonstrating the basic safety of medical electrical equipment. In order to keep the standard current with the "state of the art" in an area experiencing rapid technological evolution and continued expansion in the scope of application, those responsible for the maintenance of the 60601 series have identified a number of areas in which the General Standard could be improved. Following decisions taken at a meeting of IEC TC/ 62 in Piestany, (Slovakia), the secretary of SC62A circulated a New Work Item Proposal (NWIP) to develop and publish a 3rd edition of IEC 60601-1 on the 2nd September 1995. The NWIP was approved by the National Committees. The report on the voting on the NWIP was circulated on the 26th December 1996 and this was followed by a call from the secretary for experts for several new working groups. These, along with previously established groups are presently working together to develop the 3rd edition. The estimated time from the start of the work to completion was 8 years.

The progress of the work from commencement to the present has been reported as followes :- the first working drafts were completed and submitted to the secretary by the working groups in early 1998 and they completed individual committee drafts by the end of 1998. The Chairman's Advisory Group (CAG) edited and combined individual committee drafts. This was followed by the circulation of the 1st Committee Draft (CD) to the National Committees (NCs) for comment in May 1999. Six months were allowed to submit comments. These were considered by the WGs who developed the 2nd CD. This was circulated for comment in November 2000 with the closing date March 2001. A compilation of these comments ,all 2500 of them, was issued in October 2001. This is the current position. After consideration of the comments a CDV (Committee Draft for Voting) will be issued by March 2002. Voting to be concluded by October 2002. If the vote is positive the WGs will consider any further comments and if all is well will develop an FDIS (Final Draft International Standard) by October 2003 with voting to be completed by mid 2004. Publication of the 3rd edition by the Central Office of the IEC is expected later in 2004. All Part 2s to follow in 2006.

The 3rd edition will address items not covered in the 2nd edition such s risk management, essential performance and environmental protection. Under the heading of environmental protection it is proposed to set out manufacturers responsibilities for protection of the environment in regard to the disposal of equipment by-products and disposable items. There will be a part to deal with protection against biological hazards from non-ionization radiation such as microwaves, light radiation, ultraviolet, infrared radiation, lasers and acoustic energy including ultrasound. Requirements for Programmable Electrical Medical Systems (PEMS) will also be addressed.

Both 1st and 2nd CDs of the 3rd edition incorporated all the collateral standards. 60601-1-1 and 60601 -1-4 will be incorporated in the 3rd edition. However, IEC 60601-1-2 EMC requirements will be maintained as a collateral to the 3rd edition because of its size and the continuing evolution of the EMC requirements.

Of interest to those who may be concerned with the home use of medical electrical equipment I will quote from the introduction to the first committee draft, although part of it, " A long standing concern of several National Committees has been the clarification of the scope of IEC 60601-1 in relation to subjects such as "home use devices". This subject has been discussed for a number of years. Sub-committee 62A is endeavoring to address this concern. However it was decided at an IEC meeting in Toronto (Canada) to work on this in parallel with the 3rd edition so as not to confuse or delay the 3rd edition with what is expected to be a complex and controversial issue" Watch this space.

Whilst more work is required before completion of this most important standard we look forward to its publication.

Charles O'Neill. ETCI TC10.