IEC TC 62 Electrical equipment used in medical practice | Comments due July 16th


One of the subcommittees of IEC TC 62 has released a number of redlines that are now open for public review.   University affiliated medical research and healthcare delivery enterprises are large stakeholders in this space.

The scope of IEC TC/62 and a link to the subcommittee home page is listed below:

Scope: To prepare international standards and other publications concerning electrical equipment, electrical systems and software used in healthcare and their effects on patients, operators, other persons and the environment. NOTE : This scope includes items that are also within the scopes of other committees and will be addressed through cooperation. Attention will focus on safety and performance (e.g. radiation protection, data security, data integrity, data privacy and environmental aspects) and will contribute to regulatory frameworks. Healthcare includes medical practice as well as emergency medical services, homecare, and support of persons with disabilities in their daily lives (i.e. Ambient Assisted Living).

SC 62A Common aspects of electrical equipment used in medical practice

The redlines are listed below:

IEC 60601-1/AMD2 ED3: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2/AMD1 ED4: Amendment 1 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.

IEC 60601-1-6/AMD2 ED3: Amendment 2 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

IEC 60601-1-8/AMD2 ED2: Amendment 2 – Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-1-9/AMD2 ED1: Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design

IEC 60601-1-10/AMD2 ED1: Amendment 2 – Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers

IEC 60601-1-11/AMD1 ED2: Amendment 1 – Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-12/AMD1 ED1: Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

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Comments are due July 16th.  Electrical professionals may key in their comments directly to the IEC (CLICK HERE to register).  These redlines will also be on the agenda of the next E&H committee meeting.

 

 

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