What is the YY 9706.257-2021 Standard?

YY 9706.257 is a Chinese industry standard for medical devices and is part of the medical electrical equipment series. Its fULl title is: YY 9706.257-2021 "Medical Electrical Equipment – Part 2-57: Particular Requirements for the Basic Safety and Essential Performance of Non-Laser Light Source Equipment Used for Therapeutic, Diagnostic, Monitoring, and Cosmetic/Aesthetic Purposes".

This standard complements GB 9706.1-2020 "Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance", and focuses specifically on the safety and performance of non-laser light source medical devices.

1. Scope of Application

- Applies to non-laser light source equipment used for therapeutic, diagnostic, monitoring, or cosmetic/aesthetic purposes (such as LED, intense pulsed light [IPL], infraRED).

- Does not apply to laser equipment (which falls under YY 0505 or iec 60601-2-22).

2. Core Requirements

(1) Basic Safety Requirements

- Electrical safety must comply with GB 9706.1 general requirements, including leakage current and protection against electric shock.

- Optical radiation safety:

  * Avoid harmful UV, IR, or blue light exposure.

  * Include protective measures like filters and safety interlocks.

- Mechanical safety: Ensure stability, protection against burns, and prevention of mechanical injury.

(2) Essential Performance Requirements

- Light output parameters (e.g., wavelength, energy density, pulse width) must align with the declared medical purpose.

- High precision in control: Ensure light intensity and exposure time are accurate and reliable.

- User interface: Should be intuitive and minimize risk of misuse.

(3) Risk Management (per ISO 14971)

- Manufacturers must perform risk analysis to evaluate potential hazards such as skin burns or eye injury.

- Appropriate warning labels (e.g., “Avoid direct eye exposure to light source”) must be included.

(4) Environmental Suitability

- Equipment must function properly within the specified ranges of temperature, humidity, and power supply.

3. Relationship to Other Standards

- GB 9706.1-2020: The general parent standard for medical electrical equipment.

- YY 0505-2012: Applies to medical laser equipment. Not applicable to this standard but may offer useful optical safety references.

- IEC 62471: Used to assess photobiological hazards for non-laser light sources.

- ISO 14971: Provides the framework for required risk management procedures.

4. Testing and Certification

- Optical radiation safety testing should follow IEC 62471 or GB/T 20145.

- Electromagnetic compatibility (EMC) must meet YY 9706.102 (GB 4824).

- Clinical trials may be required to demonstrate safety and effectiveness.

5. Application Areas

- Aesthetic medical equipment: IPL devices, LED phototherapy units, infrared therapy devices.

- Therapeutic equipment: UV therapy devices, red light therapy units.

- Diagnostic equipment: Skin analyzers such as Wood’s lamp.

6. Notes

- Released in 2021; partially replaces or references older standards like YY 0323.

- Product design and testing should comply with both GB 9706.1 and this particular standard.

- For EU export, compliance with IEC 60601-2-57 is required, which is technically aligned with YY 9706.257.

If you plan to sell your medical device in China, you may contact JJR Laboratory for compliance testing.