BS EN 60601-1-3:1995 Medical electrical equipment. Part 1. General requirements for safety - Section 1.3 Collateral standard. General requirements for radiation protection in diagnostic X-ray equipment
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BS EN 60601-1-3:1995 is a European standard that specifies the general requirements for the safety and essential performance of medical electrical equipment used in the treatment of hearing impairment. The standard applies to both diagnostic and therapeutic equipment used in hospitals, clinics, and other medical facilities.
The standard covers several aspects of safety, including electrical safety, mechanical safety, and fire safety. It also specifies requirements for electromagnetic compatibility, acoustic output, and environmental conditions. The standard provides guidance on the testing procedures for these safety requirements.
In addition, the standard specifies requirements for the labeling and documentation of medical electrical equipment used in the treatment of hearing impairment, including information on their safety features and operating instructions.
It is important to note that this standard has been superseded by the updated version, EN 60601-1-3:2013. This newer version includes additional safety requirements and updated testing procedures to reflect advances in technology and changes in industry practices.
This British Standard has been prepared by Technical Committee HCC/74. It is the English language version of EN 60601‑1‑3 : 1994Medical electrical equipment — Part 1 : General requirements for safety — 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment, published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC 601‑1‑3 : 1994 published by the International Electrotechnical Commission (IEC).
The requirements of this Collateral Standard are in addition to those of BS 5724 Part 1 : 1989 hereinafter called the General Standard.
As in the General Standard, the requirements are followed by compliance tests. The numbers of the sections and clauses in this standard refer to the related sections and clauses in the General Standard. Clauses, subclauses or figures that are additional to those of the General Standard are numbered starting from 201; additional annexes are lettered AAA, BBB, etc.
A rationale giving recommendations for the provision of information concerning stray radiation is given in annex AAA. This annex does not form a normative part of the standard.
Cross-references
Publication referred to Corresponding British Standard HD 356 Sl : 1977
(IEC 406 : 1975)
BS 7534 : 1991Specification for radiographic cassettes IEC 627 : 1978 BS 5913 : 1980Method for measuring and defining the characteristics of anti-scatter grids used in X-ray equipment IEC 658 : 1979 BS 6126 : 1981Specification for dimensions of radiographic intensifying screens for medical use HD 501 Sl: 1988
(IEC 788 : 1984)
BS 6641 : 1985Glossary of medical radiology terms
The ICRP publications referred to in annex ZA are prepared by the Commission for Radiological Protection, Clifton Avenue, Sutton, Surrey SM2 5PU, and are available from Pergamon Press Ltd, Headington Hill Hall, Oxford OX3 OBW.
Additional information. The following print types are used in this standard.
Requirements, with which compliance can be tested, and definitions: in roman type.
Explanations, advice, general statements, execptions and references: in small roman type.
Test procedures: in italic type.
Terms defined in clause 2 of BS 5724 : Part 1 or in BS 6641: in small capitals.
For the purposes of this British Standard, any references to IEC page numbers in the text should be ignored.
Compliance with a British Standard does not of itself confer immunity from legal obligations.
The requirements in this Collateral Standard concern protective measures to be taken by the manufacturer in the design and construction of medical diagnostic X-ray equipment and its subassemblies. They relate to the application of the X-radiation generated, both deliberately and incidentally, in fulfilling the medical purpose of the equipment. Additional measures are necessary to regulate the generation processes themselves. These are described in the general requirements for safety, IEC 601‑1. and, where appropriate, in particular requirements for the equipment concerned.
The recommended principles governing the use of radiation for medical purposes, as stated in Publication 60 of the International Commission on Radiological Protection (ICAP), Chapter 4, have been taken into account. The implementation of these principles is essentially determined in the prevailing circumstances at the point of use. It requires judgements to be made by the user and the establishment of measures and working practices that are not necessarily connected with the construction of equipment. The requirements in this Collateral Standard are intended to be consistent with generally accepted good practice in the administration of X-radiation in medicine. In respect of economic factors, it is recognized that certain relatively inexpensive types of equipment are sometimes justifiably preferred on grounds of cost. For these, this Collateral Standard avoids imposing requirements that would unduly restrict their medical effectiveness or would add disproportionately to the cost.
In some cases, the formulation of the requirements is deliberately designed to provide scope for accommodating local laws and regulations at the time of installation and commissioning. Several of the requirements include provisions for relevant technical information to be included in accompanying documents.
Users of medical diagnostic X-ray equipment should be aware that effective protection against ionizing radiation requires the consideration of many aspects additional to the construction of the equipment. Among these are the following:
— compatibility of components and correct installation of equipment.
— the protective properties of rooms where X-ray equipment is installed;
— measures for monitoring and maintaining the safety and effectiveness of equipment throughout its life, with particular attention to components that can deteriorate progressively with time and use;
— the need in appropriate circumstances for protective clothing to be worn by staff and for suitable devices to be used to protect patients;
— the keeping of appropriate records concerning the usage of the equipment and the results of tests, with systematic review and the application of corrective action when necessary;
— the training of staff in the principles of radiation protection and in the correct use of equipment. including any protective devices provided.
Further advice on these aspects can be found in ICAP Publications 33, 34 and 60.
Readers of this Collateral Standard are reminded that, in accordance with IEC 601‑1, clause 4, all the test procedures described are type tests, intended to be carried out in a dedicated testing environment in order to determine compliance. Tests to be carried out by manufacturers to ensure compliance during production or installation and tests for detecting non-compliance subsequently to delivery, are not included.
BS EN 60601-1-3:1995 Medical electrical equipment. Part 1. General requirements for safety - Section 1.3 Collateral standard. General requirements for radiation protection in diagnostic X-ray equipment
