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EC proposal to Recast the Basic Safety Standards (and other Euratom) Directives

The European Commission (EC) intends to bring forward a formal proposal for a new Euratom Basic Safety Standard Directive which will be based on a recast and consolidation of 5 existing Directives, with a Recommendation also being taken into account. The EC is working closely on the recast with a Working Party (WP) of its Article 31 (A31) Group of Scientific Experts. The Working Party will work on the draft during 2008/09 with a view to completing a draft Directive by November 2009 and seeking an Opinion of the Group of Experts at that time. The EC is expected to then use its internal processes to issue a formal proposal for a Directive, which member states will then need to consider.

The Directives and the Recommendation to be recast (consolidated) are:

  1. Basic Safety Standards, Directive 96/29/Euratom
  2. Medical Exposures, Directive 97/43/Euratom
  3. Outside Workers, Directive 90/641/Euratom
  4. Control of high activity sealed radioactive sources and orphan sources 2003/122/Euratom
  5. Public Information Directive 89/618/Euratom
  6. Radon, Commission Recommendation 90/143/Euratom

The EC proposal will be informed by the International Atomic Energy Agency Basic Safety Standards, which are themselves being revised. It will also take account of the latest International Commission on Radiological Protection (ICRP) recommendations. The desire of the EC is that the proposal will increase regulatory consistency across the EU and ensure that newer Member States (MS) have effective regulatory frameworks.

Current Euratom Directives are implemented in the UK by a range of regulations enforced by HSE and other government departments. With respect to HSE’s interests, the Ionising Radiations Regulations 1999 and Radiation (Emergency Preparedness and Public Information) Regulations 2001 are the main statutory instruments currently used.  

HSE has convened a BSS Project Team that brings together policy, operational and technical experts to deliver this important work. The HSE team will work closely with colleagues across government and with other UK stakeholders, to ensure that their views are fully taken into account by the EC during the development of the proposal.


Work on ionising radiation equipment in hospitals

Temporary handover of controlled areas

On occasions when original equipment suppliers or third party maintenance companies carry out work on ionising radiation equipment in hospitals they may on occasion operate the equipment in a "maintenance mode" which allows the service engineer greater control over the operation of the equipment than would be available to the usual clinical operators.  This may include the ability to override protection systems for the equipment (e.g. exposure limits) or for staff & others (e.g. safety features) which are normally enabled in routine clinical operation.

Like any other work in a controlled area this work must be subject to a suitable and sufficient prior risk assessment, local rules for radiation safety and supervision by a suitably trained Radiation Protection Supervisor (RPS).  Unless other arrangements have been made then the hospital employer has this responsibility, together with a duty to co-operate with the service engineers’ employer.

The Hospital RPS may not have suitable training to supervise maintenance or repair work in the controlled area. In addition, the Hospital employer may neither have sufficient expertise to write appropriate local rules, nor be able to carry out a suitable and sufficient risk assessment.  An alternative to the Hospital employer acquiring sufficient information, and providing instruction and training to carry out these tasks directly may be to temporarily hand over the controlled area to visiting engineers for the duration of their work.  To demonstrate compliance with IRR99 this must be done in a formal manner and should follow an exchange of information between the employers. [The duty under Regulation 15 to co-operate remains.] Such arrangements are already in place in many radiotherapy centres for the servicing of linear accelerators.

Handover of equipment

HSE has published guidance on the hand over of equipment following servicing, maintenance or repair (PM77).  HSE Specialist Inspectors will investigate the arrangements in place for handover of ionising radiation equipment during inspections of hospitals.  The expected level of compliance would be for the hospital and service company (external or in-house) to have made suitable arrangements for informing the hospital of any repairs, adjustments or modification which might affect the output of the equipment or its radiation safety.


Approved Dosimetry Service (ADS) News

RADS Guidance Documents

Work is progressing on the revision of the RADS guidance documents to update references and improve consistency within and between the documents. RADS 1 is complete and will appear on the HSE website soon.  Further amendments will be notified through RP News.  The ADS Programme Manager is in discussions with the HSE Data Security Officer with regard to the arrangements for ADSs to transfer data to the Central Index for Dose Information (CIDI).  The current (temporary) recommendation is for data to be password protected on disk and posted using a traceable delivery service to the CIDI office.  RADS 3, which is otherwise complete, will be published when the details of a permanent solution are agreed (ideally a secure electronic transfer system).

Work is continuing on the other RADS documents and they will be published online in due course.

Consideration is being given to a proposal by the External Radiation Dosimetry Group to include a paragraph in the RADS documents relating to independence of ADSs.

ADS List

The ADS list on the HSE website has been revised.  The new list allows filtering/searching and is updated directly by the HSE ADS Administrators so any changes notified to them should now be updated with minimum delay.  Please let us know if any of the data is incorrect or outdated. [Write to ‘The ADS Manager, HSE, 4N.3, Redgrave Court, Merton Road, Bootle Merseyside L20 7HS]

Designated signatory

Authority has been delegated to the ADS programme manager to sign approvals on behalf of HSE.  This has been done to reduce the delay between printing and issue of approval certificates.


UK Radiation Passbook revision

The United Kingdom Radiation Passbook was revised and reprinted on 19th April 2007.  The passbook is still available to ADSs from HSE Books (order MISC224 (rev1)) at £5.50+VAT each.

The passbook has the same form factor (A6) but the cover and orientation of some of the pages has been changed.

New cover & contents page

Passbook

Readers particularly interested in the precise text changes between old and new will find full details in the ADS section of the Radiation web-pages.

Updated 2011-10-14