웨어러블 디바이스가 휴대용보다는 부착형이나 이식형으로 발전하면서, 안전문제에 따른 표준 제정이 이슈로 떠올랐다.
다양한 소재가 개발되면서 가능하게 된 부착형 및 이식형 웨어러블은 그 특성상 신체에 밀착되거나 체내에 삽입되기 때문에 안전문제가 대두되고 있다. 자연히 부착형 및 이식형 웨어러블 개발사의 관심은 정립되지 않은 국제 표준 문제로 모아지고 있다.
아직 표준과 규제가 없어 문제가 생겼을 때 책임 소재도 불명확하다는 지적도 많다. 지금 웨어러블이 사용되고 있는 현황으로 볼 때 표준화에 있어서 중요한 부분은 접근성, 정확성, 신뢰성, 보안, 생체 적합성, 내구성 등이다.
신체에 부착하거나 이식하는 웨어러블에서는 재료, 독성, 전기, 열, 인간요소(Human Factors), RF/EMI 등의 위험성을 고려해야 하기 때문에 복잡하다. 의료용 제품과 휘트니스용 제품에 따라 표준도 다르다. 의료용은 의료기기로 분류되면 ISO 14971 규격을 따르게 되지만 오작용과 남용을 미리 예측해야 한다는 점에서 웨어러블에 적용하기는 어려움이 있다.
New standard for attachment/implantation was established in IEC in February
Obtaining international secretariat status and establishing a foundation for leading international standardization As wearable devices evolve from being portable to being attachable or implantable, the issue of establishing standards for safety issues has emerged.
As various materials have been developed, attachable and implantable wearables have become possible, and because they are attached to the body or inserted into the body, safety issues are emerging. Naturally, the interest of developers of attachable and implantable wearables is focused on the issue of international standards that have not yet been established.
There are also many who point out that since there are no standards or regulations yet, it is unclear who will be held accountable when problems arise. Considering the current state of wearables, the important aspects of standardization are accessibility, accuracy, reliability, security, biocompatibility, and durability.
Rotex's biometric treatment electronic tattoo can be attached to the user's skin to analyze body temperature, breathing, etc.
Wearables that are attached or implanted on the body are complex because they must consider risks such as materials, toxicity, electricity, heat, human factors, and RF/EMI. Standards also vary depending on whether the product is for medical use or fitness use. Medical devices are classified as medical devices and follow the ISO 14971 standard, but it is difficult to apply it to wearables because malfunctions and abuse must be predicted in advance.
Biocompatibility is also not something that can be achieved with just the ISO 10993 standard. It must function without adverse effects over a long period of time and coexist with the body. In the case of devices made of metal, standardization of tests for adverse effects such as skin diseases, burns, and potential allergies is necessary, but there are only standards for smartwatches and eyeglass frames.
Contact lenses developed by UNIST to diagnose diabetes and glaucoma
When attached to the body, it is exposed to oxygen, moisture, salt, etc., so corrosion issues must also be considered. General corrosion tests cannot verify implantable devices because the conditions in the body are different. The standards applied to medical devices are also difficult because they are different from the conditions in the body. Additionally, the possibility of temporary malfunctions, data loss, and transmission errors in attached and implantable devices must be assessed.
To ensure the safety of these attachable/implantable wearable devices, the International Electrotechnical Commission (IEC) established a new technical committee (TC) in February to deliberate on international standardization of wearable smart devices.
"Interconnection with medical devices is being studied, and the market will grow through commercialization with VR/AR, etc."
The new TC will focus on standardizing electronic textiles (E-Textiles), human safety, and product reliability, which are key technologies in wearable devices. Our country has assumed the position of international secretary in TC 124, in which 19 countries, including the US, UK, Japan, and Germany, are participating.
Professor Park Jae-young of Kwangwoon University, who was appointed as the Secretary of International Standardization, said, “Now that I have been appointed as the Secretary of International Standardization, the foundation has been established to lead the international standardization of wearable devices and technology. Linkage with medical devices is being studied, and the market will grow with commercialization with VR/AR, etc. The outlook is bright as the application fields are wide.” He added, “We plan to hold the inaugural general meeting in Seoul in October following the establishment of TC124. We will take the lead in standardization by reinforcing experts.”
