I. Optical Therapy Devices: From Ancient Wisdom to Modern Technology
Light therapy as a treatment modality dates back to ancient Egypt, where sunlight was combined with herbal remedies to treat skin conditions. Today, with the maturity and widespread adoption of LED technology, red-blue light therapy devices based on LED light sources have rapidly expanded from professional medical institutions into home settings, becoming essential tools for skin repair, anti‑aging, and pain management. The global photomedicine market is projected to grow from USD 4.95 billion in 2025 to USD 7.62 billion by 2030, while the home‑use light therapy device market is expected to exceed RMB 25 billion during the same period.
Against this backdrop, product compliance has become a critical gateway for manufacturers of red‑blue light therapy devices to enter international markets, and IEC 60601‑2‑57 stands as the core safety standard in this field.
II. What is IEC 60601‑2‑57 Testing?
IEC 60601‑2‑57 is a dedicated safety standard for medical electrical equipment published by the International Electrotechnical Commission (IEC). Its full title is “Medical electrical equipment – Part 2‑57: Particular requirements for the basic safety and essential performance of non‑laser light source equipment intended for therapeutic, diagnostic, monitoring, and aesthetic use”. This standard applies to devices that use non‑laser light sources such as LEDs or intense pulsed light (IPL) within the wavelength range of 200 nm to 3000 nm, covering red‑blue light therapy devices, LED mask beauty devices, photodynamic therapy equipment, and more.
The standard imposes multi‑faceted requirements on the device:
Optical radiation safety: Irradiance and dose control, wavelength accuracy, light distribution uniformity.
Electrical safety: Insulation, leakage current, dielectric strength testing (based on the general standard IEC 60601‑1).
Mechanical safety and biocompatibility: Structural design, skin irritation assessment of contact materials.
Labelling and instructions: Marking of optical radiation parameters, contraindication warnings, and user instructions.
It is important to note that if the device employs a laser light source (e.g., fractional laser beauty devices), it must comply with IEC 60825‑1 laser safety standard, not IEC 60601‑2‑57. A new version of this standard was published in July 2023, so manufacturers should confirm the applicable version before submitting samples.
III. Red‑Blue Light Therapy Device IEC 60601‑2‑57 Testing Process
The complete testing process typically consists of the following stages:
Pre‑assessment and test plan development – The testing body first analyses the product‘s design characteristics, intended use, and target market (e.g., EU CE, US FDA, China NMPA) to determine the applicable list of test items.
Sample testing –
Optical performance testing: Spectral analysis, irradiance measurement, light output uniformity assessment.
Electrical safety testing: Dielectric strength, leakage current, grounding impedance, etc. (based on IEC 60601‑1).
Environmental and durability testing: Temperature rise, drop tests, button life, etc.
Biocompatibility assessment (if applicable) – Skin irritation testing of parts in direct contact with the skin, following ISO 10993 series standards.
Technical documentation review – Examination of the user manual, circuit diagrams, and risk analysis report (ISO 14971) for compliance with standard requirements.
Issuance of test report – Provision of a compliance test report to assist the manufacturer in applying for CE, FDA, or other certifications.
Manufacturers should prepare the product technical specification sheet, circuit schematics, key components list, user manual, and risk management documents in advance.
IV. IEC 60601‑2‑57 Testing Timeline for Optical Therapy Devices
The testing timeline is typically around 2 weeks, but the exact duration depends on the product‘s complexity – devices with multiple spectra or complex functionality take longer. If issues are discovered during testing and require corrective action, the timeline will be extended accordingly. Different certification types (e.g., CE self‑declaration vs. FDA 510(k)) may also have different reporting requirements, affecting the overall schedule. Some testing bodies offer expedited services with turnaround times of 3‑10 working days.
V. IEC 60601‑2‑57 Testing Costs for Optical Therapy Devices
The cost of IEC 60601‑2‑57 testing varies depending on the product type, the number of test items, and the target market requirements. A customised quotation is usually prepared based on the specific product. The cost components typically include optical performance testing, electrical safety testing, technical document review, and biocompatibility assessment (if applicable). Manufacturers are advised to fully communicate their needs with the testing body before submission to obtain a detailed quotation.
VI. Recommended Testing Body: Shenzhen Zhongwei Inspection
For IEC 60601‑2‑57 testing of red‑blue light therapy devices, choosing a professional and authoritative third‑party testing body is essential. Shenzhen Zhongwei Inspection Technology Co., Ltd. (CTNT) is a highly recommended choice. The company holds multiple accreditations, including CNAS accreditation (Laboratory No. L15898) and CMA qualification (Certificate No. 202119015918), and operates specialised laboratories for beauty instruments, optical performance, and laser testing.
Zhongwei Inspection has extensive experience in optical product testing and certification, particularly offering IEC 60601‑2‑57 testing services for optical therapy devices. With high testing efficiency, short turnaround times, and professional reliability, the company provides a one‑stop service that enables “one test, global acceptance”, helping manufacturers achieve rapid and compliant entry into international markets.
As the home‑use light therapy device market continues to expand and regulatory requirements become increasingly stringent, IEC 60601‑2‑57 testing has become an essential step for the export and globalisation of red‑blue light therapy devices. Manufacturers should plan their testing and certification path early, and choose a professional and reliable testing partner to ensure product safety, compliance, and a competitive edge in the market.
If you have optical therapy devices that require IEC 60601‑2‑57 testing, feel free to consult the Shenzhen Zhongwei Inspection optical testing team!
