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GB/T 41265-2022Optical radiation safety requirements of wearable devices (English PDF)

可穿戴设备的光辐射安全要求

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

March 9, 2022

Implementation date

October 1, 2022

Scope

GB/T 41265-2022 is the English-translated version of 可穿戴设备的光辐射安全要求.

GB/T 41265-2022 sets the optical radiation safety requirements of wearable devices. It gives the general requirements: the hazard groups into which a device falls, the safety assessment that places it there, and the risk control measures that follow, from the design of the source to the information given to the user.

It applies to wearable devices that emit incoherent light between 200 nm and 3000 nm, and not to devices for children under two nor to those used on light sensitive skin such as open wounds.

Makers of wearable devices and the laboratories that assess them use it. Issued on 9 March 2022, it has applied since 1 October 2022.

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Document preview — GB/T 41265-2022

National Standard of the People's Republic of China

ICS
31.260
Classification
L 51

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Contents

  • Preface
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Optical radiation hazards
  • 4.1 Overview
  • 4.2 Application Type
  • 4.3 Safety Responsibilities
  • 4.4 Exposure Limits
  • 5 Hazard category
  • 5.1 Classification rules
  • 5.2 Hazard category classification
  • 5.3 Exposure time
  • 5.4 Light emission limits
  • 5.5 Acceptance angle
  • 6 Security Assessment
  • 6.1 Overview
  • 6.2 Evaluation Conditions
  • 6.3 Achievable light emission
  • 7 Risk control measures
  • 7.1 Instructions
  • 7.2 Identification information
  • Appendix A (normative) Spectral function of ultraviolet hazard effects on cornea and conjunctiva of eyes
  • Appendix B (normative) Spectral function of skin UV damage
  • Appendix C (normative) Spectral function for retinal hazards
  • Appendix D (Informative) Optical Radiation Damage Effects

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

Introduction

The International Commission on Non-Ionizing Radiation Protection (ICNIRP) specifies safe human exposure limits for optical radiation. International Commission on Illumination (CIE) and the International Electrotechnical Commission (IEC) published the photobiological safety standard IEC 62471/CIES009.2006 for lamps and lamp systems. the mark The exposure limits are based on ICNIRP exposure limits, mainly for the intended use of lighting products (eg, reachable distance, exposure time, viewing method, etc.)

The optical radiation safety level of lamps and lamp systems is classified according to the optical radiation wavelength of.200nm~3000nm. Wearable Optical Radiation Device and Human Body In close proximity or even direct contact, the irradiation mode of light radiation is different from that of lighting products (eg, 500lx irradiation conditions,.200mm radiation distance, exposure time guidelines for hazard classes, etc.). Therefore, the classification and evaluation methods for the optical radiation safety hazard category of wearable devices, prevention Protective measures, etc., are required to be re-specified.

For the actual application of a certain wearable device product, the hazard category of optical radiation safety is required to be carried out in the specific application product standard. Regulation. Optical Radiation Safety Requirements for Wearable Devices

1 Scope

This document specifies the general requirements for optical radiation safety of wearable devices, including hazard categories, safety assessments, and risk control measures.

This document applies to wearable devices that emit incoherent light at wavelengths from.200nm to 3000nm.

Note: This document does not apply to wearable light radiation devices used by children under 2 years old, skin sensitive to light (such as open wounds), etc.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB 2893-2008 Safety Color

GB/T 20145-2006 Photobiological safety of lamps and lamp systems

GB/T 30117.2-2013 Photobiological safety of lamps and lamp systems - Part 2: Manufacturing requirements related to the safety of non-laser optical radiation guide

GB/T 34034-2017 Safety requirements for light radiation of LED products for general lighting tems)

3 Terms and Definitions

GB/T 20145-2006, GB/T 30117.2-2013, GB/T 34034-2017 and the following terms and definitions apply in this document.

3.1 Wearabledevice

A device that is directly worn on the human body or combined with clothes, accessories, etc., and is directly pasted or used close to the human body.

NOTE: This document refers to wearable devices that emit optical radiation; wearable devices generally include eye-mounted devices and skin-contact devices.

3.2 Intended use

Use of the product, enjoyment of the service or operation in accordance with the equipment specifications, instructions and other information provided by the manufacturer and the supplier.

3.3 Unintended use

Use of the product, enjoyment of the service or operation not in accordance with the equipment specifications, instructions and other information provided by the manufacturer and the supplier.

3.4 Single fault condition

A condition exists in the product that could cause a dangerous failure.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.

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