Standard No.:	GB/T 47498.1-2026
English Name:	Ophthalmic instruments—Fundamental requirements and test methods—Part 1: General requirements applicable to all ophthalmic instruments
Chinese Name:	眼科仪器 基本要求和试验方法 第1部分：眼科仪器通用要求
Chinese Classification:	C40    Medical optical instrument and endoscope
Professional Classification:	GB    National Standard
ICS Classification:	11.040.70 11.040.70    Ophthalmic equipment 11.040.70
Source Content Issued by:	SAMR, SAC
Issued on:	2026-04-30
Implemented on:	2029-5-1
Status:	to be valid
Target Language:	English
File Format:	PDF
Word Count:	10500 words
Translation Price(USD):	315.0
Delivery:	via email in 1 business day

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments 1 Scope This document specifies fundamental requirements for non-invasive ophthalmic instruments (including active and non-active ophthalmic instruments) and describes the corresponding test methods. This document is applicable to non-invasive ophthalmic instruments (including active and non-active ophthalmic instruments), as well as devices for enhancing low vision and tonometers. This document is not applicable to other ophthalmic instruments used in contact with the globe of the eye, operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 5169.10 Fire hazard testing for electric and electronic products - Part 10: Glowing/hot-wire based test methods - Glow-wire apparatus and common test procedure (GB/T 5169.10-2017 IEC 60695-2-10: 2013, IDT) GB/T 5169.11 Fire hazard testing for electric and electronic products - Part 11: Glowing/hot-wire based test methods - Glow-wire flammability test method for end-products (GWEPT) (GB/T 5169.11-2017, IEC 60695-2-11: 2014, IDT) GB 9706.1-2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2012, MOD) GB/T 14710 Environmental requirement and test methods for medical electrical equipment GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2022, ISO 10993-1: 2018, IDT) GB/T 42062 Medical devices - Application of risk management to medical devices (GB/T 42062-2022, ISO 14971: 2019, IDT) GB 47498.2-2026 Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2: 2024, MOD) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 ophthalmic instrument device designed to have an application to the eye, and intended by its manufacturer to be used in the diagnosis, treatment, or monitoring of a patient, or for compensation or alleviation of disease, injury or disability 3.2 non-invasive ophthalmic instrument ophthalmic instrument which does not in whole or in part penetrate inside the body, either through a body orifice or through the surface of the body 3.3 active ophthalmic instrument ophthalmic instrument that depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and that acts by converting this energy Note: Ophthalmic components or accessories intended to transmit energy, substances or other elements between an active ophthalmic instrument and the patient, without any significant change, are not considered to be an active ophthalmic instrument. 3.4 manufacturer natural or legal person with responsibility for design and/or manufacture of an ophthalmic instrument with the intention of making the ophthalmic instrument available for use, under his/her name, whether or not such an ophthalmic instrument is designed and/or manufactured by that person himself/herself or on his/her behalf by another person(s) [Source: GB/T 42061-2022, 3.10, modified]

Foreword i Introduction iv 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements 5 Test methods 6 Information supplied by the manufacturer Annex A (Informative) Comparison of clause/subclause numbers between this document and ISO 15004-1: 2020 Annex B (Informative) Relevant standards for ophthalmic instruments Bibliography