IEC 60601-1, 3rd Edition

IEC 60601-1, 3rd Edition

IEC 60601-1 third edition has become a common subject of discussion for medical device manufacturers in recent times. The third edition of 60601-1 represents an overhaul of the 60601 group of medical electrical equipment safety standards.

A commonly used standard, 60601-1 is an important tool for manufacturers when demonstrating compliance with the Essential Principles and Essential Requirements.  Standards selection and compliance is an important component of device development, manufacture and testing.

Some changes debated and included in the third edition of 60601-1 are as follows:

The scope of 60601-1 has been expanded to include automatic external defibrillators (AED).

The definition of medical electrical equipment has been expanded to add ‘or compensation or alleviation of disease, injury or disability’ to the definition of medical electrical equipment. Historically, medical electrical equipment was limited to devices intended by their manufacturer to ‘diagnose, treat or monitor a patient.’

Collateral standards in the IEC 60601 family have become a normative part of the general standard on the date of its publication. In effect, this approach allows for an unlimited number of amendments to add new general requirements to IEC 60601-1 because each new collateral standard becomes a nominative part of IEC 60601-1 when published.

However, the most significant change is the requirement for the manufacturers of electromedical equipment and systems to have a formal risk management system in place in order to comply with the third edition of IEC 60601-1.

There is much cross over between ISO 14971, the risk assessment standard for medical devices, and 60601-1 third edition.  For example, 60601-1 features over 100 instances where applications of a specific clause, modification of a test protocol, or provisions of a particular safety feature depend upon a determination that the risk is acceptable (or that there is unacceptable risk). Manufacturers must determine risk acceptability using ISO 14971 complaint risk management process.

For many medical device manufacturers, ensuring compliance with the third edition of 60601-1 is an important issue. Whilst there are many publically available guidance documents online, KD&A recommend working with electrical safety experts in order to properly understand specific product requirements based on the third edition requirements and complete necessary activities to achieve and maintain ongoing compliance.