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Medical Device Electrical Safety – IEC 60601-1 3rd Edition (Ed3.1)

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Medical Device Electrical Safety – IEC 60601-1 3rd Edition (Ed3.1) and Introduction to Electromagnetic Compatibility (EMC) Requirements

About this event

About the Training

December 15-16, 2021

IEC 60601-1 3rd Edition represents the benchmark for medical electrical equipment and compliance to the standard is a requirement in many countries including Europe (EN 60601-1:2006). Therefore, GMED North America has created a 2-day training session, to equip medical device manufacturers with the right strategy to ensure their Medical Device Electrical Safety processes can withstand heightened scrutiny from NBs.

This comprehensive 2-day course covers the general details of the standard and features numerous built-in knowledge checks that allow learners to apply and reinforce the new concepts throughout the training. Designed to build a solid foundation, the course explores key aspects of the standard including its general philosophy, scope, structure, evolution, adaptation for use as national standards, the use of risk management and the requirements for markings and accompanying documents.

GMED North America has created a 2-day training session, to equip medical device manufacturers with the right understanding and implementation of the Medical Device Electrical Safety Standard (IEC 6060-1 3rd Edition).

Who should attend

  • R&D professionals
  • Auditors
  • QA/RA Managers

Learning objectives

  • Determine the applicable medical equipment requirements to design products for compliance
  • Define insulation parameters and requirements
  • Determine creepage, clearance, insulation thickness and dielectric strength requirements
  • Identify appropriate grounding / earthing, fire protection and mechanical requirements
  • Create accurate and concise design and purchase specifications for critical components to achieve safety compliance goals
  • Identify performance testing, marking, documentation requirements
  • Identify the main electromagnetic compatibility (EMC) requirements according to IEC 60601-1-2 standard

Educational resources

  • Presentations
  • Practical working sessions
  • Course evaluation

Check out the Program

Days 1 & 2

The normative architecture applicable to electromedical devices

  • General standard, product standards, collateral standards, national deviations
  • Harmonized standards in Europe
  • Building a strategy for conformity assessment

Electrical safety requirements

  • Introduction to the electrical safety
  • Architecture of the IEC 60601-1 standards
  • Risk analysis
  • Definitions and vocabulary

Technical requirements of IEC 60601-1 (illustrated by case studies)

  • Protection against electric shock
  • Protection against mechanical hazards and excessive radiation hazards

Technical requirements of IEC 60601-1 (follow up)

  • Protection against excessive temperatures
  • Abnormal operation and single fault conditions
  • Construction rules
  • Marking and documentation

Electromagnetic compatibility (EMC) requirements

  • Introduction to EMC
  • Conformity verification according to IEC 60601-1-2 (case studies)
  • Integrate CEM requirements into the design process and radiocommunication requirements

About the Trainer

Dr. Sara Jafari, Ph.D.

AIMD Design Dossier Evaluator and Medical Device Certification Project Manager

Dr. Sara Jafari is an Active Implantable Medical Device (AIMD) Design Dossier Evaluator and Medical Device Certification Project Manager at GMED North America. She is a biomedical engineer and received her Ph.D. in medical imaging from the University Pierre and Marie Curie (Paris, France). Sara has extensive experiences in development of electro-medical device testing programs, including safety testing (IEC 60601-1 family of standards), evaluation of software (IEC 62304) and review of usability studies (IEC 62366-1) in addition to developing, testing and optimizing medical imaging sequences. Dr. Jafari is working as an active implantable medical device design dossier evaluator (EU directive and regulations) and certification project manager specialized in active medical devices at GMED North America.

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Location

Online event

Refund policy

Contact the organizer to request a refund.

Eventbrite's fee is nonrefundable.

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Organizer GMED North America, Inc.

Organizer of Medical Device Electrical Safety – IEC 60601-1 3rd Edition (Ed3.1)

 GMED North America. is the subsidiary of GMED, leading Certification Organization & distinguished Notified Body (CE0459).

GMED is a leading Certification Organization and a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC).

 

GMED is also an Auditing Organization Recognized by the MDSAP Regulatory Authority Council and has been performing MDSAP audits since April 2015. GMED is accredited under the NF EN IEC/ISO 17021-1:2015 standard by COFRAC (Certificate № 4-0608), the French Accreditation Committee, to carry out Quality Management System Certification activities according to ISO 9001:2015 and ISO 13485:2016. 

 

Established in 1994, GMED is fully owned by LNE (e.1901), a State owned Industrial and Commercial Establishment (EPIC), and operates since August 1st, 2018 as a simplified joint stock company (SAS) within the LNE group. 

 

GMED’s success and high level of performance rely first and foremost on a strong and dedicated team of individuals trained at the highest level of the current evaluation and auditing methods to provide the best certification services: Certification Project Managers, Subject Matters Specialists (MDAO or Medical Device Animal Origin, Medicinal Substance, Active Implantable Medical Devices, Microbiologists), Technical Documentation Evaluators and Design Dossier Assessors, Clinical Reviewers & Experts (Ex: Sterilization Methods and Validation) and Auditors for CE marking and QMS activities. 

 

With offices in Europe and a dedicated US Operation created in 2005 - GMED North America (MD), GMED offers the convenience and efficiency of local teams of experimented specialists to accompany your certification process which will allow you to market in your target markets.

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