SIST EN 60601-2-8:2015/A1:2016

Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:2010/A1:2015)

2015-09-16 - IEC inform CCMC that FDIS should be cancelled since the amendment will skip FDIS and go straight to publication

Medizinische elektrische Geräte - Teil 2-8: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Therapie-Röntgeneinrichtungen im Bereich von 10 kV bis 1 MV

Appareils électromédicaux - Partie 2-8: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de thérapie fonctionnant dans la gamme de 10 kV à 1 MV

Medicinska električna oprema - 2-8. del: Posebne zahteve za osnovno varnost in bistvene lastnosti terapevtske rentgenske opreme, ki deluje v območju od 10 kV do 1 MV - Dopolnilo A1 (IEC 60601-2-8:2010/A1:2015)

General Information

• Status: Published
• Publication Date: 08-Feb-2016
• ICS: 11.040.50 - Radiographic equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 25-Jan-2016
• Due Date: 31-Mar-2016
• Completion Date: 09-Feb-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 60601-2-8:2015/A1:2016 - Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

Relations

• Amends: SIST EN 60601-2-8:2015 - Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
• Effective Date: 06-Aug-2014

Overview

SIST EN 60601-2-8:2015/A1:2016 is a European standard developed by CLC that defines particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating within the voltage range of 10 kV to 1 MV. This standard is an amendment to EN 60601-2-8:2015 and aligns with the international IEC 60601-2-8:2010/A1:2015 publication.

The standard is critical for manufacturers, regulators, and healthcare providers to ensure medical electrical therapeutic X-ray devices meet rigorous safety, performance, and radiation protection criteria. It supports compliance with the overarching IEC 60601-1 framework for medical electrical equipment and harmonizes safety requirements across Europe.

Key Topics

• Scope and Application
  Applies to therapeutic X-ray equipment designed for radiotherapy and other medical treatments in the 10 kV to 1 MV voltage range. It covers performance aspects tailored to medical therapeutic uses, differing from diagnostic radiography equipment standards.

• Basic Safety Requirements
  Emphasizes protection against electrical hazards, radiation risks, and operational faults to safeguard patients and operators. It incorporates updates from IEC 60601-1:2005/AMD1:2012, ensuring harmonization with the latest general safety standards.

• Essential Performance
  Defines performance characteristics necessary for clinical efficacy, including accurate dose delivery and stable operation under normal and fault conditions. The equipment must maintain therapeutic effectiveness without compromising safety.

• Hazardous Situations and Fault Conditions
  Addresses identification and mitigation of hazardous situations and fault conditions specific to therapeutic X-ray devices, ensuring robust fail-safe mechanisms and risk management.

• Terminology and Definitions
  Updates terms in alignment with the amended general IEC 60601-1 standard, ensuring clarity and consistency for industry stakeholders.

Applications

• Radiotherapy Equipment Manufacturing
  Provides the essential framework for manufacturers to design and test therapeutic X-ray machines, promoting equipment safety and regulatory compliance before market introduction.

• Healthcare Facility Procurement
  Guides purchasing decisions by defining standards for safe and effective therapeutic X-ray systems suitable for cancer treatment centers and related medical institutions.

• Regulatory Compliance and Certification
  Supports conformity assessment bodies and regulators in evaluating therapeutic X-ray devices against up-to-date safety and performance criteria to meet EU Medical Device Directives.

• Radiation Protection and Safety Management
  Assists medical physicists and radiation safety officers in establishing protocols that align with recognized standards, minimizing exposure risks during therapeutic procedures.

Related Standards

• IEC 60601-1:2005 and Amendment 1 (2012)
  The general standard for basic safety and essential performance of medical electrical equipment, forming the basis for this particular part 2-8.

• IEC 60601-2-17:2013
  Covers safety and performance of brachytherapy afterloading equipment, related to therapeutic radiation devices in medical practice.

• EN 60601 Series
  A suite of European standards specifying safety requirements for different types of medical electrical equipment used in various clinical settings.

Practical Value

Compliance with SIST EN 60601-2-8:2015/A1:2016 assures that therapeutic X-ray equipment:

• Meets internationally recognized safety benchmarks, reducing electrical and radiation risks
• Delivers consistent and accurate therapeutic doses, improving patient treatment outcomes
• Aligns with EU directives to facilitate smooth market access and regulatory approval
• Supports manufacturers and healthcare providers in maintaining high standards for medical device safety and radiation protection

This standard is a cornerstone document for ensuring the safety and efficacy of therapeutic X-ray systems, contributing to improved healthcare delivery in oncology and radiotherapy fields.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2016
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLWHUDSHYWVNHUHQWJHQVNHRSUHPHNLGHOXMHYREPRþMXRGN9
GR09'RSROQLOR$,(&$
Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and
essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1
MV (IEC 60601-2-8:2010/A1:2015)
Medizinische elektrische Geräte - Teil 2-8: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Therapie-Röntgeneinrichtungen
im Bereich von 10 kV bis 1 MV
Appareils électromédicaux - Partie 2-8: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements à rayonnement X de thérapie
fonctionnant dans la gamme de 10 kV à 1 MV
Ta slovenski standard je istoveten z: EN 60601-2-8:2015/A1:2016
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-8:2015/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2016
ICS 11.040.50
English Version
Medical electrical equipment - Part 2-8: Particular requirements
for the basic safety and essential performance of therapeutic
X-ray equipment operating in the range 10 kV to 1 MV
(IEC 60601-2-8:2010/A1:2015)
Appareils électromédicaux - Partie 2-8: Exigences Medizinische elektrische Geräte - Teil 2-8: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des équipements à rayonnement X de thérapie wesentlichen Leistungsmerkmale von Therapie-
fonctionnant dans la gamme de 10 kV à 1 MV Röntgeneinrichtungen im Bereich von 10 kV bis 1 MV
(IEC 60601-2-8:2010/A1:2015) (IEC 60601-2-8:2010/A1:2015)
This amendment A1 modifies the European Standard EN 60601-2-8:2015; it was approved by CENELEC on 2015-11-03. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the
status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-8:2015/A1:2016 E

European foreword
The text of document 62C/593/CDV, future IEC 60601-2-8:2010/A1, prepared by SC 62C "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry", of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2016-08-03
national level by publication of an identical national
standard or by endorsement
(dow) 2018-11-03
• latest date by which the national standards conflicting with
the document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s), see informative Annex ZZ, included in EN 60601-2-8:2015.
Endorsement notice
The text of the International Standard IEC 6
...