IEC 60601-2-1:2009/AMD1:2014
(Amendment)Amendment 1 - Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Amendment 1 - Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Amendement 1 - Appareils électromédicaux - Partie 2-1: Exigences particulières de sécurité de base et de performances essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV
General Information
- Status
- Published
- Publication Date
- 20-Jul-2014
- Drafting Committee
- WG 1 - TC 62/SC 62C/WG 1
- Current Stage
- DELPUB - Deleted Publication
- Start Date
- 28-Oct-2020
- Completion Date
- 26-Oct-2025
Relations
- Effective Date
- 05-Sep-2023
- Effective Date
- 05-Sep-2023
Overview
IEC 60601-2-1:2009/AMD1:2014 is an important amendment to the international standard IEC 60601-2-1, specifically targeting medical electrical equipment. This amendment sets forth particular requirements for the basic safety and essential performance of electron accelerators operating in the energy range from 1 MeV to 50 MeV. Electron accelerators in this range are widely used in radiotherapy and radiation medicine, demanding strict compliance to ensure patient and operator safety as well as optimal treatment efficacy.
Issued by the International Electrotechnical Commission (IEC), this standard amendment reflects updates to safety protocols, performance verification, and equipment design considerations. It is critical for manufacturers, healthcare providers, and regulatory bodies involved with electron accelerator technology in medical applications.
Key Topics
- Safety and Performance Specifications: Clarified requirements for the basic safety and essential performance tests of electron accelerators, including radiation head safety sign displays and patient support system load testing up to 135 kg.
- Data Verification: Mandates that medical electrical equipment (ME equipment) must verify the consistency, correctness, and completeness of imported treatment data sets before allowing irradiation to commence. This enhances treatment accuracy and patient safety.
- Equipment Installation: Adjustments specify that certain general requirements do not apply when installation conditions prevent unauthorized access or insertion into critical parts, with manufacturers required to document these conditions.
- Programmable Electronic Subsystems: Emphasizes that the programmable subsystems must uphold data integrity checks and record treatment data especially after abnormal interruption or termination of irradiation.
- Electron Beam Applicators: Adds specifications for electron beam applicators, stereotactic radiosurgery/radiotherapy (SRS/SRT) beam modifying devices, and trays, ensuring all components meet stringent compliance tests.
- Cooling Water Use: Clarifies that when cooling water is required, it must meet technical descriptions specific to the device, supporting equipment reliability and safety.
Applications
IEC 60601-2-1:2009/AMD1:2014 amendment is primarily applicable to a range of electron accelerator systems used in:
- Radiotherapy Treatment: Ensuring safe delivery of electron beam therapy from 1 MeV to 50 MeV, which is essential for targeted cancer treatments.
- Medical Electrical Equipment Manufacturing: Guiding manufacturers in designing and certifying electron accelerators that meet international safety and performance standards.
- Healthcare Facilities: Enabling medical institutions to verify compliance and maintain safe operation of electron accelerators for patient treatments.
- Regulatory Compliance and Certification: Assisting regulators in evaluating conformity of medical devices for market approval and ongoing surveillance.
- Radiation Dosimetry and Quality Assurance: Enhancing protocols for calibration, testing, and monitoring of radiation dose delivery using electron accelerators.
Related Standards
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment, forming the foundation for part-specific standards like IEC 60601-2-1.
- IEC 60601-2-2: Particular requirements for basic safety and essential performance of high-frequency surgical equipment.
- IEC 60825 series: Safety standards related to laser equipment used in medical applications, occasionally complementary in radiotherapy environments.
- ISO 13485: Quality management systems for medical devices, relevant for manufacturers implementing IEC 60601-2-1 compliance.
- IEC 62304: Medical device software lifecycle processes, crucial for programmable electronic subsystems in electron accelerators.
Practical Value
Adherence to IEC 60601-2-1:2009/AMD1:2014 supports the:
- Enhanced patient safety through rigorous equipment testing and control of irradiation parameters.
- Reduction of treatment errors by enforcing strict data verification and treatment parameter selection before irradiation.
- Improved device reliability and maintainability via clear cooling water protocols and requirements for accessible parts.
- Regulatory confidence in the safety and performance of electron accelerators, facilitating smoother approvals and audits.
- Comprehensive manufacturer guidance that addresses evolving technological and clinical needs in radiotherapy equipment design.
This amendment exemplifies the global commitment to harmonizing medical electrical equipment safety, performance, and usability - advancing healthcare quality worldwide.
Frequently Asked Questions
IEC 60601-2-1:2009/AMD1:2014 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Amendment 1 - Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV". This standard covers: Amendment 1 - Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Amendment 1 - Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
IEC 60601-2-1:2009/AMD1:2014 is classified under the following ICS (International Classification for Standards) categories: 11.040.60 - Therapy equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
IEC 60601-2-1:2009/AMD1:2014 has the following relationships with other standards: It is inter standard links to IEC 60601-2-1:2009, IEC 60601-2-1:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase IEC 60601-2-1:2009/AMD1:2014 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of IEC standards.
Standards Content (Sample)
IEC 60601-2-1 ®
Edition 3.0 2014-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-1: Particular requirements for the basic safety and essential performance
of electron accelerators in the range 1 MeV to 50 MeV
Appareils électromédicaux –
Partie 2-1: Exigences particulières de sécurité de base et de performances
essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV
IEC 60601-2-1:2009-10/AMD1:2014-07(en-fr)
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IEC 60601-2-1 ®
Edition 3.0 2014-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-1: Particular requirements for the basic safety and essential performance
of electron accelerators in the range 1 MeV to 50 MeV
Appareils électromédicaux –
Partie 2-1: Exigences particulières de sécurité de base et de performances
essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX E
ICS 11.040.60 ISBN 978-2-8322-1748-1
– 2 – IEC 60601-2-1:2009/AMD1:2014
© IEC 2014
FOREWORD
This amendment has been prepared by subcommittee 62C: Equipment for radiotherapy,
nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment
in medical practice.
The text of this amendment is based on the following documents:
CDV Report on voting
62C/532/CDV 62C/562/RVC
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________
3 Terms and definitions
201.3.227
TYPE TEST
Delete this entry.
201.5.4 Other conditions
Replace the existing text of this subclause with the following:
Item 5.4 a) of the general standard does not apply.
Replacement of item 5.4 d):
d) Where cooling water is required, water as required in the technical description is used.
Addition:
The manufacturer shall state in the ACCOMPANYING DOCUMENTS any additional requirement for
testing.
© IEC 2014
201.7.3.101 RADIATION HEAD
Replace the existing text of this subclause with the following:
Removal of the covers of the RADIATION HEAD shall expose safety sign 10 of Table D.2 of the
general standard, indicating “Follow instructions for use”.
201.8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
Replace the existing text of the addition by the following:
The requirements of 8.4.2 d) of the general standard do not apply where the installation
prevents the test rod or the test pin from being inserted into the openings concerned. The
ACCOMPANYING DOCUMENTS shall state when these conditions apply.
201.9.2.2.5 Continuous activation
Delete the addition.
201.9.2.101 GANTRY, RADIATION HEAD and PATIENT SUPPORT SYSTEM
Add under a) the following new item:
5) For the patient support system, these requirements shall apply when the system is
unloaded and when it is loaded with a distributed mass of 135 kg.
201.10.1.2.101.1.5 Selection of treatment parameters
Replace the existing title by the following:
201.10.1.2.101.1.5 VERIFICATION of data coherence and selection of treatment
parameters
Add the following new item:
c) Consistency, correctness and completeness of the data set imported shall be checked by
the ME EQUIPMENT before it can be accepted for IRRADIATION.
In the case of failure of the consistency, correctness or completeness of the data set being
loaded, IRRADIATION shall not be allowed to commence.
In the case of abnormal TERMINATION OF IRRADIATION the data set necessary to reconstruct
the treatment delivered shall be recorded. (See also 201.10.1.2.101.14).
In the case of restarting after abnormal TERMINATION OF IRRADIATION, the consistency,
correctness and completeness of the data set needed for continuation of IRRADIATION shall
ME EQUIPMENT before it can be accepted for IRRADIATION.
be checked by the
MANUF
...
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