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IEC 60601-1-3 Radiology Testing

Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC 60601-1-3 Introduction:

The requirements in IEC 60601 1 3 and EN 60601 1 3 testing 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 60601-1, 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 (ICRP)[17]1), 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 part of which are 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 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.

Responsible organizations for 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.

Keystone Compliance assists manufacturers with IEC 60601-1-3 and EN 60601-1-3 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-1-3 test lab needs.