EN 60601-2-33:2010/A11:2011

Overview

EN 60601-2-33:2010/A11:2011 is a CENELEC amendment to the EN 60601-2-33 standard covering medical electrical equipment - particular requirements for the basic safety and essential performance of magnetic resonance (MR) equipment for medical diagnosis. Approved 2011-10-01, this amendment replaces Annex ZZ of the 2010 edition and clarifies the standard’s coverage of essential requirements of the EC Medical Devices Directive (93/42/EEC). The document was prepared by CLC/TC 62 and published in English, French and German.

Key Topics

This amendment and the underlying EN 60601-2-33 standard focus on particular requirements needed to ensure safe, reliable MRI systems. Key technical areas addressed include:

• Basic safety and essential performance criteria for magnetic resonance equipment
• Integration with the EN 60601 family approach to medical electrical equipment safety
• Conformity evidence to relevant EC Directive essential requirements (Annex I of 93/42/EEC)
• Informative guidance on national implementation and patent considerations

Important regulatory detail in Annex ZZ (as replaced by A11):

• The standard claims coverage of most relevant essential requirements of EC Directive 93/42/EEC except for: Essential Requirement 6a; 7.4; 7.5 paragraphs 2 & 3; and 13.6(q). Compliance with the standard therefore supports, but does not by itself guarantee, full conformity to the Directive where those exceptions apply.

Applications

Who uses EN 60601-2-33/A11 and how:

• Manufacturers of MRI scanners and subsystems - to design equipment that meets recognized European safety and performance expectations
• Regulatory affairs and conformity assessment bodies - to prepare technical documentation for CE marking and to assess compliance with the Medical Devices Directive
• Test laboratories and notified bodies - for type testing and certification work on MR equipment
• Clinical engineers and procurement teams - to evaluate safety claims, performance and compliance of MRI systems during selection and acceptance

Practical uses include product design decisions, risk management, test planning, compiling the technical file, and supporting declarations of conformity.

Related standards

• EN 60601 family (general requirements for medical electrical equipment and systems)
• EC Directive 93/42/EEC (Medical Devices Directive) - Annex I essential requirements referenced in Annex ZZ

Keywords: EN 60601-2-33 A11, MRI safety standard, magnetic resonance equipment, medical electrical equipment, CENELEC, Annex ZZ, EC Directive 93/42/EEC, basic safety, essential performance.