IRR17 (32) - Duties of manufactures etc of articles for use with work with ionising radiation.

Some definitions (supplier, article, substances)

This regulation extends the provisions of the Health and Safety at Work etc. Act 1974 (HSWA). In relation to work involving ionising radiation, this regulation requires that an appropriate critical examination of equipment is undertaken after installation. This regulation applies to suppliers of material goods, i.e. ‘articles’ or radioactive substances.

The aim of this regulation is to ensure that consideration if given to radiation protection throughout the supply chain, from design, through to manufacture, during supply and at the point of installation. The RPS and Radiation Protection Adviser are likely to be involved, with the installer, during the critical examination.

For the purposes of this regulation, and its link with HSWA, a supplier can be defined as:

• someone who supplies articles or substances by sale, lease or hire (regardless of being a principle or agent in the supply chain), and will include designers, manufactures, importers, installers and erectors etc

In addition, an article can be defined as:

• any plant, machinery, equipment or appliance that is designed for use by persons at work, and this will also extend to any component of any article

In the above definition is should be noted that an article will include equipment that produces adventitious radiation as well as intentional radiation. An example of this might be a radar installation which produces radar waves, but where the equipment may also produce adventitious x-rays.

Substances will mean:

• a sealed or unsealed radioactive substance, which could also include radioactive contamination

The regulation requires that radiation protection considerations are incorporated into the design and construction stages of manufacture and are not left to the end user.

Critical examinations

There is no legal requirement for the Radiation Protection Adviser (RPA) to be directly involved in any critical examination. However, it is a requirement that the RPA:

• advises on the nature, scope and extent of the critical examination
• gives advice on the results of any examination; ensuring that the safety features and devices designed to restrict exposure are functioning as intended
• advises on how the results should be presented and retained

Generally it is Ionactive experience that:

• For simple uses of ionising radiation (e.g. bench top x-ray QA unit) the installation / service engineer of the suppler will set up the equipment and carry out a critical examination.
• For higher hazard installations (e.g. linac / HASS / irradiators) the RPA for the installer is usually involved directly in the critical examination process.

When a new piece of equipment (an article) arrives on site which emits ionising radiations (whether entirely contained or otherwise), the person installing shall:

• where appropriate, undertake a critical examination of the way that it was erected or installed, for the purpose of ensuring in particular the safety features and warning devices operate correctly and there is sufficient protection for persons from exposure to ionising radiation
• consult with the Radiation Protection Adviser appointed by himself, or the radiation employer (where the article is being installed), with regard to the complexity and extent of the critical examination and the results of that examination
• provide the employer (who will use the article) with adequate information about proper use, testing and maintenance of the article (including a written record of the examination)

The RPS at the site when the equipment is being installed is very likely to be involved in the critical examination, if only to ‘supervise’ the work if it’s taking place in a designated area. Furthermore, many RPSs are also the users of the equipment and so have a personal interest in knowing that they have been installed and tested correctly.

Alternatively, for the higher hazard facility, at the point the critical examination is being carried out, the area may be under the control (so far as IRR17 is concerned) of the supplier rather than customer (until the area is handed over).

The critical examination should test the article under the most extreme conditions likely to be encountered in normal usage and check that all safety features / interlocks / signs and signals are operative. The user must be informed of the results of the test, including results of proven performance and operational limitations.

This requirement for testing applies only to those aspects of the equipment that have a bearing upon radiological protection. Where articles are supplied for use in work with ionising radiation that have wider areas of application, then unless specific contractual arrangements have been made regarding suitability, the responsibility for testing will reside with the employer who is the customer, rather than the supplier. An example of this might be a fan motor which is used as part of a ventilation system which controls the release of radioactive material into the workplace.

Particular care must be taken with larger projects involving potentially high hazard radiation sources (for example a linear accelerator in a bunker). Often there are several companies involved which maybe headed up by a project management group. The shielding design, construction, electrical installation, services, soft fit and similar may be conducted by different companies. In these cases the 'installer' may not be as clear as you might expect and should be agreed before the project starts. The installer of the linac cannot be responsible for the radiation shielding, or the external active warning lights that interface with the linac, if these features were not in their remit.

Ionactive spends many days a year undertaking critical examinations on behalf of suppliers and end users - particularly for high hazard facilities. If you need advice - please contact us.