British Standards Institution

Source:: IEC
Committee:: CH/62/2 - Medical imaging equipment, software, and systems
Categories:: Information management | Standardization. General rules | Healthcare | Medical equipment | Medical equipment. Radiographic

Scope

This document applies to Magnetic Resonance Imaging (MRI) equipment used, for in radiation therapy for the purposes of image-guided radiotherapy (IGRT). This particular standard covers safety aspects of MRI device in a known geometrical relationship with an electron accelerator, light ion beam therapy equipment and radionuclide beam therapy equipment, for the purpose of IGRT.

Purpose

The existing safety standard for X-IGRT (IEC 60601-2-68) only deals with X-ray based IGRT equipment. This standard will create a new variant similar in structure but for MRI based IGRT. This is a practical and clean way of achieving coverage of MRIGRT.

Amending IEC 60601-2-68 to include MRI would make this very unwieldy and would require constant change as new modalities are added. Having a unique standard per modality keeps each standard very specific and clear. This was the original intent when IEC 60601-2-68 created.

This NWIP will produce a new particular standard with basic safety and essential performance requirements for equipment that has been brought to the market.

Comment on proposal

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Discard

Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

10/08/2022

Proposal end date:

07/09/2022

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

PNW 62C-849 ED1: Medical electrical equipment - Part 2-XX: Particular requirements for the basic safety and essential performance of MRI based image guided radiotherapy equipment for use with electron accelerators

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