BS EN IEC 60601-2-1:2021 Medical Electrical Equipment Standard

Standard Number: BS EN IEC 60601-2-1:2021

Pages: 120

Released: 2021-08-13

ISBN: 978 0 580 95504 4

Name: Medical electrical equipment Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

Status: Standard

Overview

The BS EN IEC 60601-2-1:2021 standard is an essential document for professionals in the medical field, particularly those involved with medical electrical equipment. This standard specifies the particular requirements for the basic safety and essential performance of electron accelerators in the range of 1 MeV to 50 MeV. Released on August 13, 2021, this comprehensive 120-page document is a must-have for ensuring compliance and maintaining the highest standards of safety and performance in medical electrical equipment.

Key Features

• Comprehensive Coverage: With 120 pages of detailed information, this standard provides extensive guidelines and requirements for electron accelerators used in medical applications.
• Up-to-Date Information: Released in 2021, this standard reflects the latest advancements and best practices in the field of medical electrical equipment.
• ISBN: 978 0 580 95504 4, ensuring easy reference and cataloging.
• Specific Focus: Tailored specifically for electron accelerators in the range of 1 MeV to 50 MeV, making it highly relevant for professionals working with these devices.

Why This Standard is Important

In the rapidly evolving field of medical technology, ensuring the safety and performance of medical electrical equipment is paramount. The BS EN IEC 60601-2-1:2021 standard plays a crucial role in this regard by providing specific requirements that help manufacturers, healthcare providers, and regulatory bodies maintain high standards of safety and performance. By adhering to this standard, professionals can mitigate risks, enhance patient safety, and ensure the reliable operation of electron accelerators.

Who Should Use This Standard?

This standard is indispensable for a wide range of professionals, including:

• Medical Device Manufacturers: Ensure that your products meet the highest safety and performance standards.
• Healthcare Providers: Maintain compliance and enhance patient safety by adhering to the latest guidelines.
• Regulatory Bodies: Use this standard as a benchmark for evaluating the safety and performance of medical electrical equipment.
• Biomedical Engineers: Stay informed about the latest requirements and best practices in the field.

Detailed Content

The BS EN IEC 60601-2-1:2021 standard covers a wide range of topics, including but not limited to:

• General requirements for basic safety and essential performance
• Specific requirements for electron accelerators
• Testing and verification procedures
• Risk management and mitigation strategies
• Guidelines for installation, maintenance, and operation

Benefits of Compliance

Adhering to the BS EN IEC 60601-2-1:2021 standard offers numerous benefits, including:

• Enhanced Safety: Minimize risks and ensure the safety of patients and healthcare providers.
• Improved Performance: Maintain the reliability and effectiveness of electron accelerators.
• Regulatory Compliance: Meet the requirements of regulatory bodies and avoid potential legal issues.
• Market Acceptance: Gain the trust of customers and stakeholders by demonstrating adherence to recognized standards.

Conclusion

The BS EN IEC 60601-2-1:2021 standard is an invaluable resource for anyone involved in the design, manufacture, regulation, or use of medical electrical equipment, particularly electron accelerators in the range of 1 MeV to 50 MeV. By providing detailed requirements for basic safety and essential performance, this standard helps ensure that medical devices are safe, reliable, and effective. Whether you are a manufacturer, healthcare provider, regulatory body, or biomedical engineer, this standard is essential for maintaining the highest standards of safety and performance in medical electrical equipment.

BS EN IEC 60601-2-1:2021

This standard BS EN IEC 60601-2-1:2021 Medical electrical equipment is classified in these ICS categories:

• 11.040.60 Therapy equipment

IEC 60601-2-1:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for TREATMENT of PATIENTS.
NOTE 1 While ELECTRON ACCELERATORS used for TREATMENT of PATIENTS are always ME EQUIPMENT, there are times in this document where they are referred to as EXTERNAL BEAM EQUIPMENT (EBE). Usage of EBE does not remove the requirements placed on the ME EQUIPMENT but is meant to clarify that the ME EQUIPMENT being discussed is the EBE and not some other ME EQUIPMENT that may be part of the system configuration.
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the manufacture and some installation aspects of ELECTRON ACCELERATORS and their included equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT delivery
– intended for RADIOTHERAPY in medical practice, including those in which the selection and DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having
• NOMINAL ENERGY in the range 1 MeV to 50 MeV,
• maximum ABSORBED DOSE RATES between 0,001 Gy x s–1 and 1 Gy x s–1 at the ERP from the RADIATION SOURCE, and
• REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION SOURCE;
and
– intended to be
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS appropriately licensed or having the required skills for a particular medical application, for particular SPECIFIED clinical purposes,
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
• subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-1:2020 cancels and replaces the third edition published in 2009 and Amendment 1:2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with the new relevant collateral standards;
b) addition of computer interface and control;
c) addition of new technologies in RADIOTHERAPY, including
• BEAM GATING, and
• ADAPTIVE RADIOTHERAPY.