1978, British Journal of Radiology, 51, 751-752
SEPTEMBER
1978
Proceedings of The British Institute of Radiology Safety, radiological equipment and the law Abstracts of papers read at a joint meeting of The British Institute of Radiology, Royal College of Radiologists and the Royal Society of Medicine (Section of Radiology), held on Friday, January 20, 1978 in the Reid-Knox Hall, 32 Welbeck Street, London W1M 7PG. International standards in the UK, by D. T. Kerrisk. International standards in the EEC, by G. R. Higson Health and safety at work, by P. F. Beaver. Panel discussion, led by G. M. Ardran. Reprints of these abstracts can be obtained, free, on application to Mrs. L. Surry, Managing Editor, THE BRITISH JOURNAL OF RADIOLOGY, 32 Welbeck Street, London W1M 7PG (01-935 6867) both the General Standard and IEC 407 (now under revision). A manufacturer's declaration is acceptable evidence of conformity except for the radiation shielding of the X-ray tube housing for which type approval is required. IEC work in the radiotherapy field is well advanced. A standard on the safety requirements for electron accelerators, derived from RASMP 68/2, is almost ready for publication and a UK draft of a corresponding standard for cobalt teletherapy units should not take long to gain acceptance. Work is well advanced on standards for X-ray therapy equipment and it appears that IEC standards will correspond in all important aspects with the requirements of RASMP/75.
INTERNATIONAL STANDARDS IN THE UK
By D. T. Kerrisk Philips Medical Systems, London The British Standards Institute has adopted a policy of full co-operation with the International Electrotechnical Commission in its programme in Technical Committee 62 of drafting standards to cover electrical equipment used in medical practice. UK delegates drawn from many disciplines and nominated by many national bodies participate in all the working groups, together with colleagues from virtually all countries of the world. Aspects covered by the various documents include safety from both electrical and mechanical considerations, radiation protection, installation requirements, performance and methods of test, interchangeability and common markings, etc. for almost all equipment used in a medical environment—including, of course, both X-ray diagnostic and therapeutic generators. When these tasks are completed these documents will also be published as BSI national standards and in this way it is anticipated that there will be compatibility of technical requirements between nations. A survey of progress made in the areas of X-ray generators and associated accessory components was presented. Note: Periodic reports are regularly published giving the latest position by Mr. H. Bertheau, Secretary of IEC TC 62, Postfach 630121, DE-2000 Hamburg 63.
INTERNATIONAL STANDARDS IN THE EEC
By G. R. Higson Department of Health and Social Security, 14 Russell Square, London WC1B 5EP In the search for harmonized standards which can be used as a basis for rules governing international trade, the EEC is looking towards the major international standardization bodies; the International Electrotechnical Commission and the International Standardization Organization. There are currently two EEC directives dealing with trade in medical electrical equipment at an advanced stage of preparation and awaiting only the publication of appropriate IEC standards for their formal adoption. These directives instruct member states that they may not prevent the sale, free movement or use of a defined class of equipment if it complies with certain IEC standards. The first refers to a list of electro-medical equipment and calls up the forthcoming "General Requirements for Safety of Electrical Equipment used in Medical Practice". The second covers X-ray equipment, 10 kV-400 kV, and calls up
HEALTH AND SAFETY AT WORK
By P. F. Beaver Health and Safety Executive 25 Chapel Street, London NE1 5DT Following the report of the Robens Committee on Safety and Health at Work, a major new piece of legislation, the Health and Safety at Work etc. Act, was enacted in 1972. This Act is designed to secure the health, safety and welfare of all persons at work and also to ensure the protection of other persons, not at work themselves, against risks to their health and safety arising out of work activities. The Act envisages that a hierarchy of detailed subordinate requirements will eventually be produced either in the form of regulations or approved codes of practice or a combination of both. Also at this time the United Kingdom, by virtue of its obligations as a member of the EEC, is required to enact legislation to give effect to the Euratom Directive on basic safety standards for health protection against ionizing radiations. In this paper the factors affecting the scope, format and content of this legislation will be outlined and the progress of the work of drafting will be described.
PANEL DISCUSSION
Led by G. M. Ardran Department of Radiology, Old Radcliffe Infirmary, 43 Woodstock Road, Oxford OX2 6HF The papers were followed by a lively panel discussion, questions being asked by many members of the audience and directed to all the speakers. The position regarding the present state of play of impending UK legislation was clarified and the approximate timetable discussed. It was pointed
751
SEPTEMBER
1978
Proceedings of The British Institute of Radiology Safety, radiological equipment and the law Abstracts of papers read at a joint meeting of The British Institute of Radiology, Royal College of Radiologists and the Royal Society of Medicine (Section of Radiology), held on Friday, January 20, 1978 in the Reid-Knox Hall, 32 Welbeck Street, London W1M 7PG. International standards in the UK, by D. T. Kerrisk. International standards in the EEC, by G. R. Higson Health and safety at work, by P. F. Beaver. Panel discussion, led by G. M. Ardran. Reprints of these abstracts can be obtained, free, on application to Mrs. L. Surry, Managing Editor, THE BRITISH JOURNAL OF RADIOLOGY, 32 Welbeck Street, London W1M 7PG (01-935 6867) both the General Standard and IEC 407 (now under revision). A manufacturer's declaration is acceptable evidence of conformity except for the radiation shielding of the X-ray tube housing for which type approval is required. IEC work in the radiotherapy field is well advanced. A standard on the safety requirements for electron accelerators, derived from RASMP 68/2, is almost ready for publication and a UK draft of a corresponding standard for cobalt teletherapy units should not take long to gain acceptance. Work is well advanced on standards for X-ray therapy equipment and it appears that IEC standards will correspond in all important aspects with the requirements of RASMP/75.
INTERNATIONAL STANDARDS IN THE UK
By D. T. Kerrisk Philips Medical Systems, London The British Standards Institute has adopted a policy of full co-operation with the International Electrotechnical Commission in its programme in Technical Committee 62 of drafting standards to cover electrical equipment used in medical practice. UK delegates drawn from many disciplines and nominated by many national bodies participate in all the working groups, together with colleagues from virtually all countries of the world. Aspects covered by the various documents include safety from both electrical and mechanical considerations, radiation protection, installation requirements, performance and methods of test, interchangeability and common markings, etc. for almost all equipment used in a medical environment—including, of course, both X-ray diagnostic and therapeutic generators. When these tasks are completed these documents will also be published as BSI national standards and in this way it is anticipated that there will be compatibility of technical requirements between nations. A survey of progress made in the areas of X-ray generators and associated accessory components was presented. Note: Periodic reports are regularly published giving the latest position by Mr. H. Bertheau, Secretary of IEC TC 62, Postfach 630121, DE-2000 Hamburg 63.
INTERNATIONAL STANDARDS IN THE EEC
By G. R. Higson Department of Health and Social Security, 14 Russell Square, London WC1B 5EP In the search for harmonized standards which can be used as a basis for rules governing international trade, the EEC is looking towards the major international standardization bodies; the International Electrotechnical Commission and the International Standardization Organization. There are currently two EEC directives dealing with trade in medical electrical equipment at an advanced stage of preparation and awaiting only the publication of appropriate IEC standards for their formal adoption. These directives instruct member states that they may not prevent the sale, free movement or use of a defined class of equipment if it complies with certain IEC standards. The first refers to a list of electro-medical equipment and calls up the forthcoming "General Requirements for Safety of Electrical Equipment used in Medical Practice". The second covers X-ray equipment, 10 kV-400 kV, and calls up
HEALTH AND SAFETY AT WORK
By P. F. Beaver Health and Safety Executive 25 Chapel Street, London NE1 5DT Following the report of the Robens Committee on Safety and Health at Work, a major new piece of legislation, the Health and Safety at Work etc. Act, was enacted in 1972. This Act is designed to secure the health, safety and welfare of all persons at work and also to ensure the protection of other persons, not at work themselves, against risks to their health and safety arising out of work activities. The Act envisages that a hierarchy of detailed subordinate requirements will eventually be produced either in the form of regulations or approved codes of practice or a combination of both. Also at this time the United Kingdom, by virtue of its obligations as a member of the EEC, is required to enact legislation to give effect to the Euratom Directive on basic safety standards for health protection against ionizing radiations. In this paper the factors affecting the scope, format and content of this legislation will be outlined and the progress of the work of drafting will be described.
PANEL DISCUSSION
Led by G. M. Ardran Department of Radiology, Old Radcliffe Infirmary, 43 Woodstock Road, Oxford OX2 6HF The papers were followed by a lively panel discussion, questions being asked by many members of the audience and directed to all the speakers. The position regarding the present state of play of impending UK legislation was clarified and the approximate timetable discussed. It was pointed
751
