What Are The Types Of Technology Standards That Smartwatch Manufacturers Should Meet?

by Angel Waldrop

Smartwatches come into contact with one’s skin. It is through the skin that detection of most of its famous functions is made possible. Furthermore, the cases of cancers disease from an electronic device is on the rise. Therefore, smartwatches need to be manufactured under the right standards. Moreover, some features and watch 3 specifications, are very sensitive for reading health data. Thus, they must meet the set technology standards. Below are some of the different types of technology standards that smartwatch manufacturers should meet.

Different Types of technology standards that smartwatch manufacturers should meet

1. Medical equipment safety: IEC 60601-1-11

The medical equipment safety requirement is that essential performance, and basic safety is met. The collateral standard is important for home medical care. IEC 60601-1-11 standard is made assuming that medical experts will not be responsible for using the medical equipment. Therefore, it ensures that care is applied to the medical equipment, such as humidity and temperature requirements.

Furthermore, storage and handling requirements are also set. Thus, smartwatch manufacturers, especially medical smartwatch manufacturers, need to ensure that their manufacturing methods meet the IEC 60601-1-11 requirement.

2. Non-medical smartwatch: IEC/UL238-1

The IEC/UL6238-1 safety standard is for electrical hazard-based safety standards. The IEC 60065 merge with IEC/UL6238-1. The merge ensures that video and audio electrical safety standards are met. Additionally, the standard does not follow other standards in setting requirements. But its main focus is offering manufacturers a bit of leeway in establishing how to create protection.

Furthermore, the standard is meant for information processing equipment like the smartwatch. Therefore, smartwatch manufacturers must ensure that it is safe for use while performing its IT communication and information processing functions.

3. FDA approval

FDA approval is crucial for the smartwatch as it states that the smartwatch has met all the requirements. The FDA approval is especially necessary for smartwatches with the ECG for heartbeat monitoring.

4. Biocompatibility: ISO 10993

ISO 10993 provides several standards for medical devices’ biocompatibility to minimize biological risks. Biocompatibility means the medical equipment’s ability to function appropriately in a particular application host response. Therefore, smartwatch manufacturers must ensure that the smartwatches do not have adverse effects on the wearer once the smartwatch comes into contact with one’s skin.

5. ISO 62304: Software lifecycle procedure

The ISO 62304 standard is meant for medical equipment software. It is a standard that lists the life cycle procedure required for the creation of medical software and also the establishment of software in medical equipment. Smartwatches manufacturers need to ensure that they comply with the standard. Generally, it requires software safety, risk management, and quality management processes.

6. ANSI/CAN/UL 2900: Software cybersecurity

Smartwatch devices can connect to the internet. Therefore, hackers can hack into one’s smartwatch. Thus, smartwatch manufacturers must guarantee software cybersecurity.



The markets are filled with many smartwatch brands. The different brands have different qualities. Therefore, the best determinant for the best smartwatch in the market is one that meets all regulatory requirements. Furthermore, smartwatches come into contact with one’s skin. Thus, smartwatch manufacturers must protect their clients from manufactured product biomedical risk, such as skin irritation.

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