IEC 60601-2-36:2014

IEC 60601-2-36:2014 is the technical reference for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy. For engineering, procurement, and compliance teams, it helps define the expectations for evaluating a medical electrical device used in a high-risk therapeutic setting. As an original edition published in 2014, it supports technical review, documented evaluation, and conformity assessment activities where reliable safety and performance evidence is needed.

Purpose of IEC 60601-2-36:2014

The purpose of IEC 60601-2-36:2014 is to set particular requirements for lithotripsy equipment so that basic safety and essential performance can be assessed in a structured way. It is intended to support risk management, verification activities, and engineering documentation for devices that apply extracorporeal energy to break up calculi. The document is relevant when teams need a clear compliance reference for design review, laboratory evaluation, and technical validation aligned with medical electrical equipment expectations.

Compliance applications of IEC 60601-2-36:2014

IEC 60601-2-36:2014 is commonly used in product evaluation, conformity assessment preparation, and quality workflows for equipment used in extracorporeally induced lithotripsy. It may support testing plans, regulatory preparation, and internal technical assessment when confirming that a device meets the required safety and performance criteria. Procurement teams and test laboratories can also use it as a reference point when reviewing supplier documentation, acceptance criteria, and evidence needed for operational consistency across development and verification stages.

Benefits of IEC 60601-2-36:2014

Using IEC 60601-2-36:2014 can improve confidence in safety claims, testing consistency, and engineering validation for lithotripsy equipment. It provides a focused compliance reference that helps teams align design controls, verification evidence, and documentation for conformity assessment. In practical terms, it can reduce ambiguity during technical review, support clearer procurement specifications, and strengthen the traceability needed for risk reduction, regulatory preparation, and quality assurance in medical device workflows.

• Particular requirements for basic safety and essential performance of extracorporeally induced lithotripsy equipment
• Useful for design verification, test planning, and documented technical review
• Supports compliance workflows, conformity assessment, and regulatory preparation
• Relevant to procurement checks, supplier evaluation, and engineering documentation