Last Updated on
August 31st, 2023 09:46 am
IEC 60601-1 is a general standard on the basic safety and basic performance requirements of medical devices, with the continuous development of science and technology and the continuous change of medical device market demand, IEC 60601-1/AMD2:2020 edition has been released in August 2020. The corresponding EU standard EN 60601-1:2006/FprA2:2020 has also entered the stage of review.
On September 26, 2021, TUV Rheinland held a seminal seminar on the main points of changes to the medical standard IEC 60601-1/AMD2:2020 version. The seminar invited a number of well-known enterprises and well-known experts to participate in the discussion, and Long Star also participated in the seminar.
TUV Rheinland Greater China Medical device Service Assistant manager, with 12 years of experience in medical device testing teacher as the lecturer of this seminar, he for IEC60601-1 series of standards introduction and change outline made a detailed explanation, and introduced the electric shock and overtemperature protection, structure, marking documents and other requirements change.
Updating normative reference standards
Contains most parallel standard versions
- Added standards.
The updated standard clarifies some of the problems of the old standard and introduces the requirements of IEC 62368-1.
Manufacturers need to consider whether updated or new standards affect existing product designs and risks, and prepare corresponding documentation and supporting data.
2. Replace the existing requirements of subclause 7.2.3.The use of safety symbols should be based on risk management and usability engineering considerations.If applicable, the risk management documentation and usability engineering documentation shall be updated. If necessary, product nameplates, instruction manuals and other accompanying documents shall be adjusted accordingly and have compliance evidence for usability evaluation.
3. Updated Table 2 (Table 2 – Colours and meanings) according to the requirements in IEC 60601-1-8Provides further clarification between indicator lights and alarm lights.If applicable, check the color of the light and whether it is accompanied by flashing and/or sound.
4. Update the test methods and acceptance criteria for the following clauses:8.4.2, 8.5.4, 8.6.4, 8.7.3, 18.104.22.168, 13.1.2, 13.2.1, 15.3.5, 22.214.171.124...etc.The original test results should be re-examined. When necessary, re-evaluate according to the new test method.
5. Added Figure 40 ((Figure 40)
(Figure 40 – Identification of MEANS OF PATIENT PROTECTION and MEANS OF OPERATOR PROTECTION)
Insulation protection according to IEC 60950-1:2005 or IEC 62368-1:2018 can be used as operator protection (MOOP). However, there is no automatic conversion to Patient Protection (MOPP).
The purpose of the newly added process is to assist developers to determine security protection requirements. Although IEC 62368-1 is referenced, it can only supersede some requirements.
The final compliance still has to be assessed according to the original process (Figure 5) and risk management. Among them, special attention needs to be paid to the limiting conditions of the working voltage.
The changes mentioned above mainly consider general medical equipment. For specific medical devices and complete standard requirements, please refer to the complete standard.