IEC 60601-1-10:2007/AMD1:2013
Amendment 1 - 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
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About This Item
IEC 60601-1-10:2007/AMD1:2013 is an amendment to the medical electrical equipment series focused on the development of physiologic closed-loop controllers. It is relevant when engineering teams need to assess how control functions respond to patient-related physiological inputs and how those controls are documented within a broader basic safety and essential performance framework. For organizations working on technical review, conformity assessment, or risk management, the document helps clarify the expectations connected to this specialized control approach and its role in medical device compliance workflows.
Purpose of IEC 60601-1-10:2007/AMD1:2013
The purpose of IEC 60601-1-10:2007/AMD1:2013 is to modify the parent document, IEC 60601-1-10:2007, with requirements tied to physiologic closed-loop controllers used in medical electrical equipment. As an amendment, it supports engineering documentation and technical validation by refining how these control systems are developed and evaluated. That makes it relevant to teams preparing design files, conducting documented evaluation, and reviewing performance criteria within safety-oriented medical device development and regulatory preparation activities.
Compliance applications of IEC 60601-1-10:2007/AMD1:2013
In compliance workflows, this amendment is commonly used alongside the parent reference during product evaluation, verification activities, and conformity assessment for medical electrical equipment that relies on automated physiological feedback control. It may be consulted by design engineers, test laboratories, and regulatory specialists when reviewing closed-loop behavior, operational consistency, and supporting technical documentation. For procurement and standards libraries, IEC 60601-1-10:2007/AMD1:2013 serves as a focused compliance reference within broader medical safety and essential performance assessments.
Benefits of IEC 60601-1-10:2007/AMD1:2013
This document helps organizations maintain a clearer and more defensible technical basis for closed-loop control development in medical equipment. By connecting the amendment to the parent standard, teams can better align engineering specifications, testing workflows, and quality assurance records. That can support safer system behavior, more consistent laboratory evaluation, and stronger preparation for conformity assessment. For companies managing regulated products, the amendment also helps reduce ambiguity during technical review and can improve the reliability of compliance documentation across the product lifecycle.
- Supporting amendment linked to IEC 60601-1-10:2007 for physiologic closed-loop controller development
- Relevant to medical electrical equipment design, safety review, and essential performance evaluation
- Useful for verification activities, laboratory evaluation, and regulatory preparation
- Helps align technical documentation with compliance and risk management workflows
- Publication Date: 2013-11-27
- Standard Status: Amendment
- Publisher: IEC
- Edition: 1
- New Version Available: IEC 60601-1-10:2007 (2020-07-22)
- This Version: IEC 60601-1-10:2007 (2013-11-27)
- Previous Version: IEC 60601-1-10:2007 (2007-11-21)
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