The release of IEC 60601-1:2005 + A1;2012 + A2:2020, also known by the name of IEC 60601-1 (Edition 3.2) Medical device manufacturers need to take note of different time frames for regulatory transitions across the world. Based on previous experience with prior transition periods for international standards around the world and based on the conclusion that, in addition to the amendment 2:2020 in IEC 60601-1 that a transition timeframe is set at 3-4 years for most regions and countries. It is possible that only a few countries will need to be in conformity with the previous standard (edition 3.1) in longer periods.
In the standard general to IEC 60601-1, there are 78 issues that are addressed in amending 2:2020. Additionally, 32 issues are addressed by a variety of other standards, including IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8 IEC 60601-1-10 and so on. Beyond that , the standards mentioned have been completely revised or up-to-date, e.g. IEC 62133-2, IEC 62366-1:2015+A1:2020, IEC 62368-1:2018, ISO 14971:2019. The specific standards IEC 60601-2-XY are scheduled to be published within two years from August 2022 or in the event that the responsible standard committee for part 2 does not adhere to the timeframe it will be announced in IEC Central Office. IEC Central Office within an official way only (update of standards that are referenced only). Click here for 60601 testing.
What is IEC 60601-1 (EDITION 3.2)?
IEC 60601 is one of a collection of technical standards designed to assure the safety of medical equipment. IEC 60601-1 (Edition 3.2) covers the fundamental safety and specifications for performance for medical electrical equipment and ensures that any single mechanical, electrical, or functional issue can create a significant risk for the operator or patient. It is believed that health authorities in a number of countries recognize IEC 60601-1 (Edition 3.2) as prerequisite for commercialisation of medical equipment using electrical power. IEC 60601-1 (Edition 3.2) is the most current standard that has been published with approximately 1500 single specific requirements. The requirements are usually regarded as State-of-the-Art (SOTA) and have to be met in all market sectors around the world.
What’s the reason?
IEC 60601-1 (Edition 3.2) will likely be a standard that is widely accepted across countries like the U.S., Canada, the EU, Japan, Brazil, Russia, and Australia. Certain major import countries or regions (e.g. EU as well as Australia) for these equipment must be aware of the most recent state-of-the-art (SOTA) specifications. This is the reason why the latest IEC/ISO standards are not acceptable following their typical three to four years of transition is over. To ensure that they are not denied access to these and other markets, manufacturers must ensure that their products conform with both editions 3.1 as well as 3.2 in the standards.
IEC 61010 for IVD MEDICAL ELECTRICAL EQUIPMENT
IEC 61010-1 describes the global standard for safety standards for electrical equipment used for measurements, control, and use in laboratories.
Laboratory equipment that is electrical is a reference to
Measurement equipment that displays the presence of, monitors, inspects or analyzes materials is used to make materials
Instrumental diagnostic (IVD) equipment, including self-testing IVD equipment that can be used at home
Equipment for inspection to be used to verify materials or individuals when transporting
This IEC 61010-1 standard contains however, it is not restricted to, mechanical hazards, electrical dangers, spreading of fire in the equipment and laser sources, as well as ultrasonic and sonic pressure. This standard IEC 61010-2-101 can also be used to the in-vitro diagnosis (IVD) medical uses and self-testing IVD medical uses. This standard also adds additional specific requirements for products used in medical diagnostic (IVD) medical instruments to the standard, including biohazards as well as dangerous chemical substances.
