Designing for Compliance to IEC 60601-1 3rd Edition - Live Virtual Classroom – Session 8: Medical Equipment and Systems: Construction and Component Requirements; Markings and Labelings, Accompanying Documents

Description

Presented by experienced UL engineers knowledgeable in evaluating products for certification to U.S. and international standards for medical equipment, this workshop will help you gain an understanding of the “Construction and Component Requirements” portion of our curriculum related to Medical Equipment and Systems – Designing for Compliance to 60601-1:2005.

This session is one of eight virtual sessions on the subject of “Designing for Compliance to IEC 60601-1 3rd Edition” that are offered either individually or as a bundled offering of all eight topics.  If you wish to take the complete bundle of topics related to 60601-1 3rd Edition, click here for a full description and bundled pricing.

Workshop Topics:

• Construction and Component Requirements
• Markings and Labeling, Accompanying Documents

Objectives

• Identify component requirements and means of  establishing compliance
  • Unlike the 2nd edition the 3rd edition includes component requirements via references to IEC component standards. These components are not necessarily medical equipment ones but include ones like switches and wiring. See component flowchart (Fig 5 in standard).
• Create accurate and concise design and purchase specifications for critical components to achieve safety compliance goals.
• Identify required markings such as:
  • Graphics
  • Safety signs
  • Indicator lights
• Develop the necessary documentation

Target Audience

• Product safety engineers
• Compliance engineers
• Product designers
• Regulatory approval staff
• Production support engineers
• Quality assurance staff
• Technical marketing professionals