Standards are considered an integral part of product design and development. Standards are very important in medical device applications. Some of the most critical standards exist in the medical device industry for ensuring the electrical safety of devices. Millions of electronic devices that produce electricity or work on it, rely on IEC (International Electrotechnical Commission) International Standards and Conformity Assessment Systems to perform, fit and work safely together. The IEC was established in 1906 and is the world’s leading organization for the preparation and publication of International Standards for active and inactive devices. These are collectively known as “electrotechnology.”
IEC 60601-1 refers to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS (referred to as ME EQUIPMENT and ME SYSTEMS respectively).
Image below shows the various types of IEC standards:
Types of standards
- Primary Standards
- Collateral Standard
- Particular Standards
- In metrology, primary standard is a standard that is sufficiently accurate and it is not subordinate to or calibrated by other standards.
- The primary standard is formally known as IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- Primary standards are referred to as IEC 60601-1 or simply “60601” and the primary standards are considered as an essential requirement to comply with the standard for introducing new devices and marketing them in different countries.
- Collateral standards 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 specific.
- The “collateral” standards are denoted as IEC 60601-1-x; for example, IEC 60601-1-2 is the EMC collateral standard. Other collateral standards include 60601-1-3 (radiation protection for diagnostic x-ray systems), 60601-1-8 (alarm systems).
- Particular standards are regarded as the equipment specific standards. .
- Particular standards are denoted as IEC 60601-2-x that define specific requirements related to a specific type of products e.g. 60601-2-10 covers the performance of nerve and muscle stimulators.
Evolution of IEC 60601
IEC 60601 has undergone various modifications to match with the evolving technology in the medical space.
- The 1st version was released in 1977 (1st edition) and covered the basic safety of active medical devices like MRI, Implantable Cardioverter-Defibrillator and the first artificial heart, etc.
- The 2nd version of the standard was released in 1988 to cover the basic safety requirements of medical devices like smart infusion system, LASIK surgery, Da Vinci Surgical Instrument and X-ray machines etc.
- The 3rd edition was created to provide safety requirements for medical devices like Nanotechnology, Electrical and Electronic products, insulating materials and systems etc.
- To overcome the issues which were ambiguous in the 3rd edition, 3.1 edition was released in 2012. Formally referred to as IEC 60601-1: 2005+AMDI: 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.
- The 4th version was released to illustrate the safety requirements of wireless controlled technology like WIFI, Bluetooth and PDA devices etc. The fourth edition deals majorly with “Electromagnetic Compatibility (EMC) concerns”.Fig 3- Evolution timeline of IEC 60601 in accordance with device development
In order to adapt and comply with the new standard versions, Medical Device Manufacturers conducted gap assessment between the new and the old standards. As a result of this assessment, many design related documents were impacted and had to be updated (taking design control into account). This is a complex phenomenon and Regulatory Experts can come in handy (Elexes Medical Consulting).
Due to updates in 60601 basic safety standard from 1st edition to 4th edition, medical device manufacturers had to perform the electrical safety testing again. Further, to stay in compliance with design control requirements (21CFR 820.30 Design control) System requirement specifications, Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HA) and Design History File (DHF), etc were updated by the Manufacturers.
Global adoption of IEC 60601-1
Member countries of the European Union and many other countries in Europe now comply with 3.1 Edition (EN 60601-1 A1:2013) with the adoption of the 4th edition EMC standard (EN 60601-1-2:2015) in effect from December 31, 2018.
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. This was subsequently amended to December 31, 2018 to harmonize with the EU timeline for its 4th edition adoption.
Adopted 3rd edition IEC 60601-1:2005 with Amendment 1 from March 1 2019.
China is currently aligned to 2nd edition as endorsed by its GB 9706.1- 2007 standard along with a collateral EMC standard YY 0505-2012 effective from January 1, 2014.
Brazil complies to Edition 3.1 of the standard since September 25, 2015.
South Korea complies to 3rd edition since June 1, 2014, for Class 3 & 4 devices, since June 1, 2015, for Class 2, and since June 1, 2016, for Class 1. It transitioned to Edition 3.1 on January 1, 2018.
Looking at the benefits that the medical device manufacturer can provide to the intended users by making the device comply with electrical safety standards, countries across the world are adopting these standards. In spite of the criticism of this complexity that the standard brings, there are huge advantages of complying with these standards.