What is IEC 60601-1?

What is IEC 60601-1?

Standards are an integral part of product design and development, and are certainly important in medical applications. IEC 60601 is a series of technical standards applies to Medical Electrical Equipment & Medical Electrical System for Basic Safety & Essential Performance. The basic scope of IEC 60601-1 is safety of patient, user and the equipment.

Some of examples of Medical Electrical Equipments:

Why IEC 60601-1 ?

IEC 60601-1 is the primary standard governing medical device design, Safety & essential Performance so compliance with this standard has become requirement for bringing new medical devices into Market. Medical products must go through compliance testing and device approval before they can be marketed. Also, IEC 60601 compliance issues can result in delays when you prepare your medical device regulatory submission for a specific market, leading to delayed market entry. ITC India can assist with IEC 60601 compliance and regulatory submissions to the European Notified Bodies for CE Marking and for other regulators to gain market access. It is also a mandatory standard for UL and CSA markings.

Amendments in IEC 60601-1:

60601-1 Edition 3.1 was introduced in 2012 by the IEC to address many issues identified as unclear or ambiguous in the original 3.0 standard that was released in 2005. Formally referred to as IEC 60601-1: 2005+AMD1: 2012, this updated standard includes almost 500 changes and clarifications across a spectrum of subjects, including essential performance, risk management, mechanical testing, temperature testing, and humidity testing. The amended standard also defines several new specifications for mechanical and electrical hazards.

Collateral & Particular Standards of IEC 60601-1.

There are 8 Collateral and 47 Particular Standards in IEC 60601 Series.The general requirements of 60601-1 apply to all medical electrical equipment and part 2 (Particular)standards apply to specific categories of medical electrical equipment. However, there is another level in this hierarchy of standards: the collateral standards. These are applied more selectively than the general requirements, either in terms of the topic they cover or the type of equipment, but they are not as specific as the part 2(Particular) standards. In standards world they are referred to as semi-horizontal standards.

The global adoption of IEC 60601-1:

  • Member countries of the European Union and many other countries in Europe currently.
  • comply with the 3rd edition of the standard, known in Europe as EN60601-1:2006.
  • The US and Canada currently require compliance with Edition 3.1 and originally targeted April 1, 2017 for compliance with the changes required by IEC 60601-1-2.
  • Japan compliance to the 3rdedition standard.
  • China is currently aligned to 2nd edition.
  • Brazil has required compliance to Edition 3.1 of the standard.
  • South Korea has required 3rd edition compliance.
  • Taiwan requires 2nd edition compliance with 3.0 and 3.1 editions being optional.

ITC India Pvt Ltd offers testing for compliance with Standard IEC 60601-1, We are India based Electrical Safety Testing Laboratory Accredited by NABL (ISO/IEC 17025). We also have EMC, EMI testing facility to get your Medical Electrical Equipment compliance with EMC & EMI Standards Requirement. For more information please visit to www.itcindia.org or email us on info@itcindia.org or call us on +91 9316473033