Document TRS 89

TECHNICAL REQUIREMENTS FOR THE SUPPLY AND INSTALLATION OF EQUIPMENT FOR DIAGNOSTIC IMAGING AND RADIOTHERAPY(1989)

Crown Copyright 1989

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TRS 89

TECHNICAL REQUIREMENTS FOR THE SUPPLY AND INSTALLATION OF EQUIPMENT FOR DIAGNOSTIC IMAGING AND RADIOTHERAPY (1989)

Diagnostic Imaging & Electromedical Product Group (PG4A) Supplies Technology Division NHS Procurement Directorate Department of Health 14, Russell Square London, WC1B 5EP

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PREFACE TRS 89 replaces TRS 86. It is the sixth edition in the "TRS" series, which started with RS 76. Most of the changes in the new edition arise from the publication of relevant new international and British standards, also the "Guidance Notes for the Protection of persons against Ionising Radiations arising from Medical and Dental Use". The latter has replaced the familiar "Code of Practice", and provides a new documentary basis for radiation protection measures. By citing the new standards in TRS 89, they become part of the total package of requirements to be taken into account in achieving compliance with TRS 89. In consequence, a number of requirements specifically stated in TRS 86 that have exact or close counterparts in the new standards, have been deleted from the text of TRS 89. It is of course no coincidence that requirements stated in earlier TRS editions have found their way into the new standards. A number of purely editorial changes have been made. Among these is the replacement of "apparatus" with the more commonly used term "equipment". By introducing the phrase "SHALL (subject to declared VARIATION)" it has been possible to abolish the device of assigning different meanings to the word "SHOULD", depending on whether or not it was underlined in the text. Other editorial changes have been directed towards increased clarity and more helpful annotation. As usual, a list of the principal changes is included (page iv). In the presentation of TRS 89, the practice has been continued of retaining certain paragraph numbers and subject headings established in earlier editions, even when they contain no current requirements. This is done to assist cross referencing. Where appropriate, references are given to the paragraphs in which equivalent requirements are currently to be found (usually because they have been assimilated into cited standards).

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PRINCIPAL DIFFERENCES BETWEEN TRS 89 AND TRS 86

Paragraph No. Nature of change 1.2 New terms introduced and others redefined. 1.4.1 Revised. 1.4.2 Note added. 1.6 Address updated. 2.1.1 Note added. 2.1.2 Four Particular Standards added. 2.1.3 Revised (cites BS 5850). 2.1.4 Not used (requirement assimilated in 2.1.2). 2.2.1 Revised (now based on GUIDANCE NOTES). 2.2.2 Not used (replaced by contents of 2.2.1). 2.2.3 Not used (replaced by contents of 2.2.1). 2.2.4 Not used (no longer relevant). 2.2.6 Not used (no longer relevant). 2.4.2 Revision of first sentence. 2.10.1 Revised (requirements separated into new sub-paragraphs). 2.10.2 New paragraph (contains requirement formerly in 2.1 0.1). 2.10.3 New paragraph (states requirement formerly implied in 2.10.1). 2.10.4 New paragraph (contains requirement formerly in 2.1 0.1). 2.10.5 New paragraph (contains requirement formerly in 2.1 0.1). 2.11.1 Redrafted to improve clarity. 2.14.1 Revised (wearing parts specifically mentioned). 2.18.1 Revised (specific reference to mild steel parts deleted). 2.20.3 Note added. 2.22.1 Redrafted to improve clarity. 3.1 Not used (requirement assimilated in 2.1). 3.3 Not used (requirements assimilated in 2.1). 3.4.1 Note added. 3.5 Not used (requirements assimilated in 2.1 and 2.2). 3.6.2 Notes revised. 3.7.2 Not used (requirement assimilated in 2.2.1). 4.2 Not used (requirement assimilated in standards now cited). 5.3 Not used (latching requirement deleted).

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SPECIAL NOTE CONCERNING THE HEALTH AND SAFETY AT WORK ETC ACT (1974) Nothing in TRS 89 is to be construed as permitting, encouraging or condoning the violation of the Health and Safety at Work etc. Act (1974). Attention is drawn to The Ionising Radiations Regulations 1985 and to the Approved Code of Practice "The Protection of Persons against Ionising Radiation arising from any Work Activity", which are especially relevant to articles and services falling within the scope of TRS89. The obligation to comply with the Act may compel the implementation of measures additional to those described in TRS89.

INTRODUCTION ............................................................................................... 1 1.1 Scope ............................................................................................................ 1 1.2 Definitions ..................................................................................................... 1 1.3 References to this Document ........................................................................ 5 1.4 VARIATIONS and CONCESSIONS .............................................................. 5 1.5 Interpretations ............................................................................................... 6 1.6 Communication with THE DEPARTMENT .................................................... 6 1.7 Metrication use of SI Units ......................................................................... 7 2 GENERAL REQUIREMENTS ............................................................................ 7 2.1 ITEM SPECIFICATIONS and Safety Standards ........................................... 7 2.2 Radiation Protection...................................................................................... 8 2.3 Electrical Safety ............................................................................................ 9 2.4 Requirements concerning PRE-INSTALLATION WORK .............................. 9 2.5 Electrical Supply Connections to Equipment............................................... 10 2.6 Immunity to Supply Failure.......................................................................... 10 2.7 Protective Earthing...................................................................................... 10 2.8 Earth Leakage Current ................................................................................ 11 2.9 Mechnical Safety......................................................................................... 12 2.10 Electric Cables......................................................................................... 12 2.11 Power-driven movements ........................................................................ 12 2.12 Marking.................................................................................................... 14 2.13 Marking of Controls etc............................................................................ 14 2.14 Accessibility ............................................................................................. 14 2.15 Fuses....................................................................................................... 14 2.16 Wheeled Equipment ................................................................................ 15 2.17 Hand switches and Foot switches ....................................................... 15 2.18 Protection against Corrosion ................................................................... 15 2.19 Protection of Ventilation Holes................................................................. 16 2.20 Documentation ........................................................................................ 16 2.21 Provision and Storage of Service Documents ......................................... 16 2.22 Graduation of Positional Scales............................................................... 16 2.23 Diaphragm plates, Cones and Applicators............................................... 16 3 PARTICULAR REQUIREMENTS FOR DIAGNOSTIC X-RAY EQUIPMENT AND RADIOTHERAPY TREATMENT SIMULATORS ........................................... 16 3.1 Exposure Indicator ...................................................................................... 16 3.2 Light Beam Diaphragms.............................................................................. 17 3.3 Features of MOBILE X-ray UNITS .............................................................. 17 3.4 Exposure Counters ..................................................................................... 17 3.5 Exposure terminating Circuits ..................................................................... 17 3.6 Over-pressure Protection of X-ray Tube Housings...................................... 17 3.7 X-ray Tube Filtration.................................................................................... 18 3.8 X-ray Tube focal spot position..................................................................... 18 3.9 Fluoroscopy interlock .................................................................................. 18 3.10 Interlock for compression procedures etc. ............................................... 19 3.11 Time-sharing Control Systems ................................................................ 19 4 PARTICULAR REQUIREMENTS FOR RADIOTHERAPY EQUIPMENT ........ 19 4.1 Elapsed Time Indicator ............................................................................... 19 4.2 Compliance with RASMP/75 ....................................................................... 19 4.3 Additional Protection against Electric Shock ............................................... 19

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PARTICULAR REQUIREMENTS FOR FILM PROCESSING UNITS .............. 20 5.1 Thermal Cuts-Outs...................................................................................... 20 5.2 Prevention of contact with moving parts...................................................... 20 5.3 Access Covers ............................................................................................ 20 5.4 Control of Water Flow ................................................................................. 20 5.5 Emergency Switching.................................................................................. 20

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1 INTRODUCTION
1.1 Scope These requirements are intended for incorporation in contracts for the supply and installation in premises of the National Health Service of equipment for diagnostic Imaging and radiotherapy, including diagnostic X-ray equipment and accessories, radiotherapy equipment, radiotherapy treatment simulators, radioisotope gamma cameras and scanners, magnetic resonance imaging equipment and ultrasonic scanners. 1.2 Definitions Defined terms in this document are printed in capital letters. These are listed below in alphabetical order, with their meanings: BS 5724: PART 1: BS 5724: PART 1: 1979. Specification for Safety of Medical Electrical Equipment. Part 1: General Requirements Published by the British Standards Institution. BS 5724: Section 2.1: 1984 Safety of Medical Electrical Equipment Specification for medical electron accelerators in the range 1 MeV to 50 MeV Bs 5724: Section 2.7: 1987 Medical Electrical Equipment Part 2 Particular Requirements for Safety Section 2.7 Specification for High Voltage Generators of Diagnostic X-ray Generators. BS 5850: 1981 Specification for safety of electrically energised office machines. BS 6059: 1981 Essential data to be supplied with X-ray tubes and X-ray tube assemblies for medical use A body having responsibility for co-ordinating the supply of particular categories of goods and services to the National Health Service on behalf of a group of PURCHASERS and empowered to act on behalf of the group in respect of functions assigned to a CENTRE OF RESPONSIBILITY in TRS 89.

BS 5724: SECTION 2.1::

BS 5724: SECTION 2.7:

BS 5850:

BS 6859:

CENTRE OF RESPONSIBILITY:

CONCESSION:

An agreement made with THE CONTRACTOR whereby an obligation to comply with a specific requirement of TRS 89 is waived subject to conditions specified in the agreement. The grant of a CONCESSION has no effect on the measures necessary to achieve compliance with TRS 89. Goods and services supplied under a CONCESSION therefore cannot properly be claimed to comply in full, although they may be acceptable to THE PURCHASER under circumstances specified in the CONCESSION. An organisation or body supplying goods and services to THE PURCHASER under contract conditions that include the obligation to comply with TRS 89. Supplies Technology Division, NHS Procurement Directorate, Department of Health, acting through a duly authorised representative. A room primarily intended for patients to be present for the purpose of diagnosis involving the use of any equipment, which is subject to the requirements of TRS 89. A terminal forming part of the protective earth system in a room and designated as a reference or datum for the purpose of defining and measuring resistance values An ITEM OF EQUIPMENT or selection of interrelated ITEMS OF EQUIPMENT that when installed constitutes the means for carrying out specific functions in the diagnosis or treatment of patients. Guidance Notes for the protection of persons against lonising Radiations arising from Medical and Dental Use published by the National Radiological Protection Board, the Health and Safety Executive, the Department of Health and Social Security, the Department of Health and Social Services (Northern Ireland), Scottish Home and Health Department and the Welsh Office ISBN 0 85951 299 1 (on Sale through Her Majestys Stationery Office). The person or organisation appointed by THE PURCHASER and notified to THE CONTRACTOR as being empowered to receive goods and services at a particular site and to perform the functions assigned to THE HOSPITAL AUTHORITY in TRS 89. If no such appointment is notified, the PURCHASER is deemed to be also THE HOSPITAL AUTHORITY.

THE CONTRACTOTR:

THE DEPARTMENT

DIAGNOSTIC ROOM:

EARTH REFERENCE TERMINAL:

EQUIPMENT ASSEMBLY:

GUIDANCE NOTES

THE HOSPITAL AUTHORITY:

IEC 601-1

Publication 601-1 Safety of Medical Electrical Equipment. Part 1: General Requirements. Published by Bureau Central de la Commission Electrotechnique Internationale. Particular Requirements for the Safety of Therapy Xray Generators First Edition 1987. Published by Bureau Central de la Commission Electrotechnique Internationale Particular Requirements for the Safety of Gamma Beam Therapy Equipment First Edition 1987 Published by Bureau Central de la Commission Electrotechnique Internationale. Particular Requirements for the Safety of Capacitor Discharge X-ray Generators First Edition 1988. Published by Bureau Central de la Commission Electrotechnique Internationale Regulations for Electrical Installations Fifteenth Edition 1981, published by the institution of Electrical Engineers. The person or organisation appointed by THE PURCHASER and notified to THE CONTRACTOR as being empowered to perform the functions assigned to THE INSPECTOR in TRS 89. If no such appointment is notified, THE PURCHASER is deemed to be also THE INSPECTOR. Any equipment identified by its inclusion as an individual entry in a list or schedule of articles to be supplied, associated with a contract to which the requirements of TRS 89 apply. The specification agreed between THE PURCHASER and THE CONTRACTOR describing the content and characteristics of an ITEM OF EQUIPMENT. Indicates a permissible method or procedure for complying with a requirement in TRS 89.

IEC 601-2-8:

IEC 601-2-11

IEC 601-2-15

IEE REGULATIONS:

THE INSPECTOR

ITEM OF EQUIPMENT:

ITEM SPECIFICATION:

MAY:

MOBILE EQUIPMENT:

TRANSPORT EQUIPMENT Intended to be moved from one location to another between periods of use while supported by its own wheels or equivalent means of support, such as a

trolley. MOBILE X-RAY UNIT: MOBILE EQUIPMENT intended to be used for the radiographic examination of patients and intended for this purpose to be moved routinely into various parts of a hospital complex. Document PD 5686: 1978, The use of SI Units, published by the British Standards Institution. Work done in preparation for installation of equipment for which responsibility is taken by the HOSPITAL AUTHORITY but for which the requirements are specified by THE CONTRACTOR. An organisation or body entering into a contract for the supply of goods and services under conditions that include the obligation to comply with TRS 89. Indicates a requirement necessarily to be satisfied for compliance with TRS 89. When qualified by the phrase (subject to declared VARIATION) the requirement is one for which compliance can also be achieved by means have been declared by THE DEPARTMENT to be acceptable under the procedure for VARIATIONS (see paragraph 1.4.1). Indicates a requirement to be satisfied as far as practicable.

PD 5686

PRE-INSTALLATION WORK:

THE PURCHASER:

SHALL:

SHOULD:

STATIONARY EQUIPMENT: Equipment that is fastened or otherwise secured at a specific location in a building or a vehicle, or equipment that is not intended to be moved from one place to another, except within a course or area restricted by means such as rails, guides, pivots etc. TRANSPORTABLE EQUIPMENT: Equipment intended to be moved easily from one place to another whether or not connected to the supply and without and appreciable restriction of range. A room primarily intended for patients to be present for the purpose of treatment or the planning of treatment involving the use of any equipment that is subject to the requirements of TRS 89. This document (abbreviated form of title) . A declaration made by THE DEPARTMENT (with or without a request having been made) concerning

TREATMENT ROOM:

TRS 89 VARIATION:

compliance with requirement of TRS 89 by means other than the means described in TRS 89 itself. VARIATIONS will usually apply to requirements allowing scope for alternative means of compliance because their degree require of requirement is SHALL (subject to declared VARIATION). Exceptionally, a VARIATION may be used to resolve difficulties in the application or interpretation of other requirements also. Where compliance with a requirement is achieved under the terms of a VARIATION the resulting status of compliance with TRS 89 is as it would have been if the requirement have been if The requirement had been met in the terms actually stated in TRS89.

1.3

References to this Document

The numbered parts of this document are described as paragraphs. Where it is necessary to refer to a particular paragraph, the recommended forms are as follows: Example: Full form: To refer to this paragraph:Technical Requirements for the supply and installation of Equipment for Diagnostic Imaging and Radiotherapy (1989), paragraph 1.3 TRS 89/1.3

Abbreviated form: 1.4

VARIATIONS and CONCESSIONS

1.4.1 Details of current VARIATIONS are available on request to THE DEPARTMENT and may also be published at the discretion of THE DEPARTMENT. Note: In all cases, applications are treated as confidential until a Variation has been declared and the matter thus becomes relevant to THE PURCHASER. In order to facilitate early application, applicants for VARIATIONS may request THE DEPARTMENT not to disclose details for a period prior to the product concerned being offered on sale, in order to protect commercial confidentiality. Where it is agreed to proceed on this basis, THE DEPARTMENT will not disclose details of any consequently declared VARIATION to any third party until either the applicant has agreed

to disclosure or details of the product concerned have been released by the applicant. 1.4.2 Requests to consider the declaration of new VARIATIONS may be made to THE DEPARTMENT by THE CONTRACTOR, THE PURCHASER, THE INSPECTOR concerned in any particular transaction, or by others having reasonable cause to be concerned about the means of securing compliance with the requirements of TRS 89. Only THE DEPARTMENT is enabled to declare a VARIATION. Note: Prospective contractors are advised that applications for VARIATIONS are appropriately made before, rather than after, a contractual commitment has arisen to comply with TRS 89 in respect of the product(s) concerned. 1.4.3 Applications for CONCESSIONS should be addressed by THE CONTRACTOR to THE DEPARTMENT. THE DEPARTMENT will deal with them in accordance with arrangements for the time being force with the CENTRE OF RESPONSIBILITY concerned. The details of any relevant CONCESSIONS granted SHALL be disclosed by THE CONTRACTOR when offering to supply goods or services against a requirement to comply with TRS 89. The details may also be made known by THE DEPARTMENT or by the CENTRE OF RESPONSIBILITY to persons or bodies having reasonable cause to require such information in connection with the procurement of goods and services for National Health Service. 1.5 Interpretations

In the event of THE CONTRACTOR being in doubt about the way in which the requirements of TRS 89. (Including requirements in the cited documents) will be interpreted for the purposes of determining compliance, he may make a request for interpretation in writing to THE DEPARTMENT. The advice of THE DEPARTMENT is available to any party making use of TRS 89. This may extend to mediation or arbitration in a dispute if all the parties concerned have agreed with THE DEPARTMENT on such a course. 1.6 Communication with THE DEPARTMENT

Communications with THE DEPARTMENT concerning TRS 89 should be addressed to: Mr I R F Hendra Supplies Technology Division NHS Procurement Directorate Department of Health Room 614A, 14 Russell Square London WC1B 5EP

(Telephone: 01-636 6811 Ext. 3151) 1.7 Metrication use of SI Units

SI units SHOULD be used in accordance with PD 5686 for the expression of all quantities including radiation quantities. In order to avoid the difficulty that there is no special SI name for a unit exposure corresponding to the roentgen, it is preferred that the quantity exposure be avoided. The quantity air Kerma (measured in air) is one of the acceptable alternatives. For the energy range encountered in diagnostic radiology an exposure of 1 roentgen may be taken to correspond to an air kerma of 8.7 milligrays.

2 GENERAL REQUIREMENTS
2.1 ITEM SPECIFICATIONS and Safety Standards

2.1.1 Each ITEM OF EQUIPMENT SHALL comply with its ITEM SPECIFICATION. The standards of manufacture of all equipment (including design, construction, testing, installation and documentation) SHALL be to the satisfaction of THE PURCHASER. Note: The nature of the requirements in TRS 89 is such that it is necessary for all stages of manufacture to take place under the control of effective quality systems. THE PURCHASER may require compliance with appropriate standards of manufacturing practice. 2.1.2 ITEMS OF EQUIPMENT falling within the defined scope of BS 5724: PART 1 SHALL comply with the requirements of that standard taken together with the relevant requirements of that standard taken together with relevant requirements of the following Particular Standards applied in accordance with sub clause 1.3 BS 5724: PART 1:BS 5724: SECTION 2.1 medical electron accelerators BS 5724: SECTION2.7-high voltage generators IEC 601 2-8 therapeutic X-ray generators IEC 601-2-11-gamma beam Therapy equipment IEC 601-2-15-capacitordischarge X-ray generators Such ITEMS OF EQUIPMENT SHOULD also comply with the advisory statements in the above standards, where applicable, unless exempted by any other paragraph in TRS 89.

2.1.3 ITEMS OF EQUIPMENT failing outside the scope of BS 5724: Part 1 MAY comply with BS 5850,otherwise they SHALL (subject to declared VARIATION) comply with BS 5724: Part 1. Notes: (i) The intended effect of paragraph 2.1.3 is to commit. THE CONTRACTOR to agreed and relevant alternative safety standards where BS 5724: PART1 is not automatically invoked under paragraph 2.12 and is seen to be inappropriate for the ITEM OF EQUIPMENT under consideration. (ii) The requirements of IEC 601 1 are regarded as equivalent to those of BS 5724: PART1 excepting those given IEC 601 1 on page 38 in lines 17 to 20 and 25 to 30 (concerning the colours of insulation of conductors), and on page 74 in lines 14 to 16 (concerning radiation protection).

2.1.4 Not used 2.2 Radiation Protection

2.2.1 Compliance with the GUIDANCE NOTES:Equipment shall comply with recommendations in the GUIDANCE NOTES that relate to its design, construction and installation and SHALL be so designed, constructed and installed as to facilitate its use in accordance with all relevant recommendations in the GUIDANCE NOTES. Note: A number of specific requirements relating to radiation protection are contained in the published standards cited in TRS 89. The obligation to comply with these is governed by paragraphs 2.1, 2.12.2 and 2.20.2. In general, compliance with relevant prevailing published standards is among the recommendations of the GUIDANCE NOTES.

2.2.2 2.2.3

Not used. Not used.

2.2.4 Not used. 2.2.5 The minimum lead equivalent SHALL be permanently and clearly marked on the protective glass of all fluorescent screens and on all protective barriers, cubicles and clothing. 2.2.6 Not used 2.2.7 Excess filtration: Equipment assemblies should be so constructed that they can be operated to their intended purposes without the total beam filtration significantly exceeding the minimum value required to comply with the relevant stands cited in TRS 89. 2.2.8 Not used. 2.3 Electrical Safety This subject is addressed in the standards currently cited in TRS 89/2.1 2.4 Requirements concerning PRE-INSTALLATION WORK

2.4.1 THE CONTRACTOR SHALL specify to THE HOSPITAL AUTHORITY any required PRE-INSTALLATION WORK including for example, the provision of electrical and other supply points, electrical interconnections, ceiling fixings and floor mountings, and all features necessary to enable the installation to comply with TRS 89. THE CONTRACTOR SHALL also include in the specification for PRE-INSTALLATION WORK the requirement that those parts of the electrical supply system that are relevant to the proposed installation are to comply with IEE REGULATIONS, unless otherwise specified. Note: Several of the requirements in TRS 89 relate to features of installations which in certain cases will properly form part of PREINSTALLATION WORK. The responsibility of THE CONTRACTOR for compliance with such requirements MAY be discharged wholly or in part by the appropriate specification of PRE-INSTALLATION WORK in accordance with this paragraph.

2.4.2 THE CONTRACTOR SHOULD inspect the PRE-INSTALLATION WORK and SHALL not proceed with an installation if he believes or has reason to suspect that its condition in incompatible with safety and reliability in the completed installation. THE CONTRACTOR MAY consult THE DEPARTMENT in the event of difficulty in reaching agreement with THE PURCHASER or with THE HOSPITAL AUTHORITY on measures to be taken to enable installation to proceed. 2.4.3 Copies of all documentation provided to the HOSPITAL AUTHORITY by THE CONTRACTOR in connection with an installation SHALL be provided to THE DEPARTMENT if THE DEPARTMENT so requests. 2.5 Electrical Supply Connections to Equipment Note: See also paragraph 5.5 concerning film processors. 2.5.1 Means for isolation and switching of electrical supplies to equipment SHALL be provided in accordance with the requirements of the IEE REGULATIONS. 2.5.2 For each EQUIPMENT ASSEMBLY installed in a DIAGNOSTIC ROOM or TREATMENT ROOM a single master control SHOULD be provided, in a position conveniently accessible from normal operating position, to enable operating staff switch off that EQUIPMENT ASSEMBLY entirely as a routine procedure (except those parts requiring continuity of supply, e.g. clocks, vacuum pumps and data storage systems). Where appropriate this requirement MAY be met by suitable choice and location of the means for isolation and/or switching of supplies provided under paragraph 2.5.1 2.5.3 STATIONARY EQUIPMENT SHALL be connected by means of permanent connections using fixed wiring protected against mechanical damage. 2.6 Immunity to Supply Failure This subject is addressed in the standards currently cited in TRS 89/2.1 Protective Earthing

2.7

2.7.1 The protective earthing of all parts of every installation SHALL be of a standard not inferior to that required for compliance with IEE REGULATIONS. 2.7.2 Earth continuity between equipment and the associated mains isolator(s) SHALL not depend solely upon the continuity of conduits, ducts or trunking. 2.7.3 An EARTH REFERENCE TERMINAL SHALL be provided or designated for every DIAGNOSTIC ROOM and TREATMENT ROOM. THE EARTH REFERENCE TERMINAL SHALL comply with the following requirements. i. It SHALL be directly connected by means satisfying the requirements of the nearest convenient point in the protective earthing system of the circuit of largest current carrying capacity among those supplying equipment in the room, so as to become a part of that system.

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ii. It SHALL be of appropriate size and form to accommodate the additional conductors (if any) that are to be connected to it, and for this purpose it MAY be a multiple connection device. Where the circuit identified in (I) is a circuit supplying only socket outlets in the room and no additional conductors have to be connected, the EARTH REFERENCE TERMINAL MAY be the earth contact of any selected one of the socket outlets.

iii. It SHALL be labelled Earth Reference Terminal or ERT 2.7.4 The protective earthing system of socket outlets in DIAGNOSTIC ROOM intended for procedures involving electrically conducting connections to the patient (including catheterisation procedures) SHALL be bonded to the EARTH REFERENCE TERMINAL by means of a copper conductor of cross section not less than 6 square millimetres or the equivalent. 2.7.5 In a DIAGNOSTIC ROOM or TREATMENT ROOM all STATIONARY EQUIPMENT SHALL be protectively earthed by means of a network of permanently connected conductors so that resistance of not more than 0.1 ohm exists through this network between the protective earth terminal of each installed unit and the EARTH REFERENCE TERMINAL. Note: The term network in this paragraph allows the conductors to be wired radically, or in a ring, or in a combination of radical and ring connections. It is not essential for separate connection to be made between each protective earth terminal and the EARTH REFERENCE TERMINAL. 2.7.6 The method of verifying that earthing is in accordance with paragraph 2.7.5 on a completed installation SHALL be as follows:i. By visual inspection it SHALL be verified that a network has been connected using conductors complying with the IEE REGULATIONS and of such lengths and cross-sectional areas that the resistance requirement in paragraph 2.7.5 is likely to be satisfied. ii. The resistance SHALL be measured between each protective earth terminal (see BS5724: Part 1 sub-clause 2.6.8) and the EARTH REFERENCE TERMINAL. The maximum acceptable resistance in this test SHALL be 0.1 ohm.

Note: The measurement in (ii) alone does not prove compliance with paragraph 2.7.5 because paths additional to that deliberately provided through the network could exist and could obscure the fact of inadequate conductivity in the qualifying path. Inspection of design and construction as in (I) is an essential step in the verification process. 2.8 Earth Leakage Current This subject is addressed in the standards cited in TRS 89/2.1

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2.9

Mechnical Safety This subject is addressed in the standards cited in TRS 89/2.1

2.9.1 Not used 2.9.2 All components SHALL be used in accordance with any ratings or application data recommended or agreed by their manufacturers for the intended purpose. Where no relevant information exists, components SHOULD be used in accordance with recognised good practice supplemented by appropriate tests. THE CONTRACTOR SHALL provide evidence of the adequacy of any component if requested to do by THE INSPECTOR or THE DEPARTMENT. 2.9.3 The security of all attachments and fastenings SHOULD be safeguarded by the use of appropriate locking devices to prevent them from loosening or becoming detached after assembly. 2.10 Electric Cables 2.10.1 Cables associated with the installation of ITEMS OF EQUIPMENT SHALL be used within their electrical, mechanical and environmental ratings. 2.10.2 Cables SHALL be suitably protected against undue wear, accidental damage, excessive temperature, the effects of ionising and non-ionising radiations and chemical attack. 2.10.3 The numbers of cables drawn into, or laid in, a conduit or trunking SHALL not be such that damage is caused to the cables during their installation. 2.10.4 Cable entries to conduit and trunking systems SHALL be effectively bushed or flared to prevent abrasion. 2.10.5 Unenclosed cables SHALL be provided with effective strain relief at connection points and all cables SHALL be of adequate length to prevent strain arising in any available configuration of the equipment. 2.11 Power-driven movements The following requirements apply to power-driven movements that are intended to be used in the presence of a patient located o n or close to the equipment: -

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2.11.1 Unless excepted below, power-driven movements SHALL (subject to declared VARIATION) be provided with supplementary independent means to enable the movement to be stopped by the operator, in the event of failure of the means of control normally used. Exception: The powered movement of an X-ray tube with its associated structure, normally made during, or in preparation for tomographic examination and having a duration not exceeding 10 seconds. Notes: Where supplementary means of stopping powered movements are not incorporated in the design of the equipment itself, the requirements of paragraph 2.11.1 can often be met by the use of one or more suitably placed emergency off push buttons arranged to switch off the electrical supply. Provided that no hazard would be introduced by the use of such devices, it is unnecessary to have a separate device for each movement or to confine the switching action to the circuits actually feeding the movements. Importance should, however be attached to locating the devices where they can be reached and used immediately by the operator, and to marking them distinctively.

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2.11.2 Each movement in which motion is intended to be stopped in normal operation at a stage observed by the operator while motion is in progress, SHALL be controlled in such a way that motion is not possible except by the continuous actuation of a controlling device (e.g. a switch biased to the stop position). 2.11.3 In all systems in which a failure could result in a patient being trapped or suspended in a position from which he could not quickly and safely be removed from the equipment, means SHOULD be provided to enable the configuration to be suitably adjusted under manual control. 2.12 Marking 2.12.1 Each ITEM OF EQUIPMENT SHOULD be permanently and clearly marked with serial number and the month and year of supply or manufacture. Such markings SHOULD be placed where they can be seen without removing covers etc. If labels are used they SHOULD be of durable type and SHOULD be firmly attached. 2.12.2 X-ray tube assemblies SHALL (subject to declared VARIATION) be marked so that the markings taken together with the accompanying documentation (see paragraph 2.20) will constitute compliance with BS 6059. 2.12.3 All controls, instruments and indicating devices SHALL be permanently and clearly marked to indicate their functions. Markings in plain language SHALL be in English. Markings by symbols SHOULD follow established international practice and their meanings SHALL be described in the operating instructions. 2.12.4 The purposes of any electrical connectors provided for the connection of accessories, if not marked on the equipment adjacently, SHALL be fully described in the operating instructions. 2.13 Marking of Controls etc. 2.13.1 See paragraph 2.12.3. 2.14 Accessibility 2.14.1 Equipment SHOULD be designed and installed so as to be accessible for servicing and inspection, especially the inspection of components that are subject to progressive deterioration with use, such as wire rope cables. Where the periodic replacement of components for reasons of safety is foreseen, it SHOULD be practicable to effect the replacement on site. 2.15 Fuses See also paragraph 2.1

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2.15.1 Not used 2.15.2 Where cartridge fuses are employed, at least one spare fuse-link of each type and rating used, SHALL be provided. Spare fuse-links SHOULD be mounted on the equipment with accessibility corresponding to that of the fuseholder concerned (i.e. if the fuseholder is accessible to the operator so also SHOULD be the spare fuse-link). 2.16 Wheeled Equipment 2.16.1 Wheel-locks, or other devices to prevent accidental movement while in use, SHALL be fitted to patient trolleys, to mobile image intensifiers, to MOBILE X-RAY UNITS (unless fitted with brakes), and to MOBILE EQUIPMENT that is intended to be electrically connected or otherwise attached to a patient. The locks or other devices SHOULD be constructed so that their application and release is at the discretion of the operator. 2.16.2 MOBILE EQUIPMENT SHOULD be equipped with appropriate buffering or other energy absorbing means to prevent damage to the fabric of buildings within which it is intended to be moved in the course of normal use.

2.17 Hand switches and Foot switches 2.17.1 Hand-switches and foot-switches connected to equipment by flexible cords SHALL not contain conductors or components operating at voltages greater than 24 V ac or 50 V dc 2.18 Protection against Corrosion 2.18.1 Metal parts that are susceptible to corrosion SHALL be suitably protected.

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2.19 Protection of Ventilation Holes 2.19.1 Ventilation holes in equipment enclosures SHOULD be protected by louvres or other effective means to prevent the ingress of fluids or other matter, particularly those associated with normal use. 2.20 Documentation 2.20.1 All equipment SHALL be provided with explicit and comprehensive operating instructions in English. 2.20.2 The documentation supplied with X-ray tube assemblies SHALL (subject to declared VARIATION) be such as to constitute compliance with BS 6059 when taken together with the marking (see paragraph 2.12.2). 2.20.3 With all equipment, circuit diagrams and other documents that might reasonably be required to facilitate service and maintenance SHALL be provided. This documentation SHALL be in English or, in the case of diagrams and illustrations, MAY be furnished with translations of the legends and annotations into English. The documents SHOULD be stored by arrangement with the HOSPITAL AUTHORITY concerned, in a fixed lockable container near the equipment to ensure safe custody and ease of access for any person having reasonable need to consult them. THE CONTRACTOR SHOULD amend the documents when appropriate to conform with any modifications carried out on the equipment. Note: The practice of storing documents in equipment racks, not properly adapted for the storage of combustible material, is deprecated. 2.21 Provision and Storage of Service Documents This subject is addressed in TRS 89/2.20.3 2.22 Graduation of Positional Scales 2.22.1 Linear scales SHALL be graduated in metric units (e.g. centimetres). The graduations of angular scales SHALL be based on the angular degree. 2.23 Diaphragm plates, Cones and Applicators 2.23.1 All diaphragm plates, cones and applicators SHALL be permanently and clearly marked with field coverage details.

3 PARTICULAR REQUIREMENTS FOR DIAGNOSTIC X-RAY EQUIPMENT AND RADIOTHERAPY TREATMENT SIMULATORS
3.1 Exposure Indicator This subject is addressed in the standards currently cited in TRS 89/2.1

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3.2

Light Beam Diaphragms

3.2.1 Light beam diaphragms SHALL (subject to declared VARIATION) be fitted with time-limiting switches controlling the light source supply, so that the ontime following a setting of the switch does not exceed 2 minutes. 3.3 Features of MOBILE X-ray UNITS This subject is addressed in the standards currently cited in TRS 89/2.1 Exposure Counters

3.4

3.4.1 Exposure counters SHALL be fitted to allow the total number of exposures made with each rotating anode tube to be recorded separately. Note: Exposure counting devices need to be able to hold their accumulated count indefinitely. This is a factor to be taken into account particularly with digital electronic counters. 3.5 Exposure terminating Circuits This subject is addressed in the standards currently cited in TRS 89/2.1 and TRS 89/2.2 Over-pressure Protection of X-ray Tube Housings

3.6

3.6.1 Every sealed housing containing an X-ray tube SHALL (subject to declared VARIATION) be fitted with a switch arranged to open as a result of the accumulation of energy within the housing to an extent such that further accumulations might cause an excessive pressure to develop within the housing. 3.6.2 Any switch fitted in accordance with paragraph 3.6.1 SHALL be connected so that any sources of electrical energy are disconnected if their continued application might cause an excessive pressure to develop within the housing. Notes: i. It is the essence of the requirements in TRS 89/3.6.1 that an overpressure protection device should be fitted to the X-ray tube assembly and that protection should not depend solely on the electrical control system of the generator. However, it is recognised that the need for disconnection of energy sources does not arise where there is inherent limitation of the possible rate of energy input to a value not exceeding the natural cooling rate of the housing. ii. In view of the impracticability of verifying compliance with TRS 89/3.6.1 by inspection or test after manufacture, THE CONTRACTOR should be prepared to provide evidence of tests carried out to verify the effectiveness of the device fitted.

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iii.

It is recognised that a device of the kind described cannot prevent a rise of pressure following failure of the X-ray tube itself, with oil coming into contact with an incandescent tube target. X-ray Tube Filtration

3.7

3.7.1 Marking of inherent filtration is addressed in the standards currently cited in TRS 89/2.2.1 and TRS 89/2.12.2. 3.7.2 Marking of filters is addressed in the standard currently cited in TRS 89/2.2.1 3.7.3 THE CONTRACTOR, when installing an X-ray tube or tubehead, SHALL ensure that any necessary additional filter is fitted to provide the appropriate total filtration according to the recommendations in the GUIDANCE NOTES applying to the techniques and purposes for which the X-ray tube has been supplied. 3.8 X-ray Tube focal spot position This subject is addressed in the standard currently cited in TRS 89/2.12.2 Fluoroscopy interlock

3.9

3.9.1 A fluoroscopic exposure SHALL not be possible unless the image receptor is correctly positioned with respect to X-ray tube. Expect for radiotherapy treatment simulators installed in a shielded room with control of fluoroscopic exposures solely from outside the room, the image receptor SHALL (subject to declared VARIATION) intercept the entire cross section of the useful beam.

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3.10 Interlock for compression procedures etc. 3.10.1 Interlocks SHALL (subject to declared VARIATION) be provided to prevent powered relative movement between a patient and component which is locked in contact with patients body as, for example, during compression procedures. 3.11 Time-sharing Control Systems 3.11.1 In a time sharing control system used on equipment that has fluoroscopic facilities, the means SHALL be provided to enable continuous access to the generator to be obtained for the entire duration of an examination that includes fluoroscopy.

4 PARTICULAR REQUIREMENTS FOR RADIOTHERAPY EQUIPMENT

4.1 Elapsed Time Indicator

4.1.1 Every radiotherapy installation utilising an X-ray tube SHALL be provided with an elapsed time indicator to record the accumulated working hours of the tube 4.2 Compliance with RASMP/75 Requirements under this heading have been replaced by those in the relevant standards cited in paragraph 2.1 and in the GUIDANCE NOTES cited in paragraph 2.2. Additional Protection against Electric Shock The following protective measures (4.3.1 and 4.3.2) apply to medical electron accelerators where regular tasks such as servicing or calibration require the removal of access covers, thereby giving access to live parts with which accidental contact would be possible: -

4.3

4.3.1 Where the live parts are at high voltage (exceeding 650 v), access covers SHALL (subject to declared VARIATION) be interlocked with a dual system embodying safety switches of approved design and operating in a fail-safe mode. In addition, manual earthing facilities SHALL be provided for the high voltage parts. 4.3.2 Where live parts operating at mains voltage (240 V) are in close proximity to parts to which access is required for routine test and/or adjustment the live parts SHALL be covered to prevent accidental contact. If the necessary access requires the removal of covers also such live parts, the live parts SHALL be independently shrouded.

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5 PARTICULAR REQUIREMENTS FOR FILM PROCESSING UNITS

5.1 Thermal Cuts-Outs

5.1.1 Every system employing a heating element SHALL be provided with a thermal cut-out in addition to any device used to maintain normal operating temperatures, arranged to disconnect the supply to the element in order to prevent danger or damage in the event of absence (or partial absence) of liquid or reduction of air flow or modification of any other condition on which the maintenance of normal temperatures is dependent. The cut-out MAY be of a self-resetting type but the circuit SHALL (subject to declared VARIATION) be such that restoration of the disconnected supply is possible only the deliberate operation of a control. 5.2 Prevention of contact with moving parts

5.2.1 Film processors SHALL be constructed so that no danger arises from accidental contact with moving parts or the opening of covers provided to give access without the aid of tools for routine procedures such as film clearance, replenishment or cleaning. Protection MAY be afforded by shielding of the moving parts or by appropriate interlocking to inhibit movement when the covers are not fully closed or by preventing possibility of injury. 5.3 Access Covers Not used Control of Water Flow

5.4

5.4.1 Where correct operation requires a particular flow rate of water, the means to maintain the flow rate automatically within the required limits SHALL (subject to declared VARIATION) be included in the installation. 5.5 Emergency Switching

5.5.1 Film processors SHALL be provided or installed with means for switching off in an emergency. These means SHALL be in accordance with the requirements of the IEE REGULATIONS and SHALL be readily accessible from the vicinity of both the input and output sections of the processor. Note: See also paragraph 2.5 concerning general requirements for the electrical supply connections to equipment.

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