GB/T 11239.1-2025 Optics and photonics - Operation microscopes - Part 1: Requirements and test methods English, PDF
1 Scope
This document specifies the requirements for operation microscopes and describes the test methods for them.
This document is applicable to operation microscopes used for observation during surgical operation and treatment of patients.
It does not apply to accessories, e.g. photographic cameras.
Note: Specific requirements with regard to optical radiation hazards from operation microscopes used in ocular surgery are given in ISO 10936-2.
2 Normative References
The following documents contain requirements 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 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (GB 9706.1-2020, IEC60601-1: 2012, MOD)
GB/T 10050 Optics and optical instruments - Reference wavelengths (GB/T 10050-2009, ISO 7944: 1998, IDT)
GB/T 20146 CIE standard illuminants for colorimetry (GB/T 20146-2006, CIES005: 1999, IDT)
JB/T 9328-2024 Resolving power test target
YY 9706.102 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
operation microscope
stereomicroscope used for observation of surgical and other medical procedures, consisting of an illumination system and an observation system (including objective lens, variable or fixed power optical system, observation tube, and eyepieces)
Example: Colposcopes.
4 Requirements
4.1 General
The operation microscope shall conform to the requirements in 4.2 to 4.12.
All requirements given below are minimum requirements. The reference wavelength shall conform to the requirements given in GB/T 10050.
4.2 Optical and mechanical requirements
The operation microscope shall conform to the requirements in Table 1.
Testing of optical and mechanical requirements shall be carried out in accordance with 5.2.
Contents
Foreword i
Introduction iv
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test methods
6 Marking
Annex A (Informative) Comparison of clause/subclause numbers
Annex B (Informative) List of technical differences and justifications
GB/T 11239.1-2025 Optics and photonics - Operation microscopes - Part 1: Requirements and test methods English, PDF
1 Scope
This document specifies the requirements for operation microscopes and describes the test methods for them.
This document is applicable to operation microscopes used for observation during surgical operation and treatment of patients.
It does not apply to accessories, e.g. photographic cameras.
Note: Specific requirements with regard to optical radiation hazards from operation microscopes used in ocular surgery are given in ISO 10936-2.
2 Normative References
The following documents contain requirements 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 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (GB 9706.1-2020, IEC60601-1: 2012, MOD)
GB/T 10050 Optics and optical instruments - Reference wavelengths (GB/T 10050-2009, ISO 7944: 1998, IDT)
GB/T 20146 CIE standard illuminants for colorimetry (GB/T 20146-2006, CIES005: 1999, IDT)
JB/T 9328-2024 Resolving power test target
YY 9706.102 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
operation microscope
stereomicroscope used for observation of surgical and other medical procedures, consisting of an illumination system and an observation system (including objective lens, variable or fixed power optical system, observation tube, and eyepieces)
Example: Colposcopes.
4 Requirements
4.1 General
The operation microscope shall conform to the requirements in 4.2 to 4.12.
All requirements given below are minimum requirements. The reference wavelength shall conform to the requirements given in GB/T 10050.
4.2 Optical and mechanical requirements
The operation microscope shall conform to the requirements in Table 1.
Testing of optical and mechanical requirements shall be carried out in accordance with 5.2.
Contents of GB/T 11239.1-2025
Contents
Foreword i
Introduction iv
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test methods
6 Marking
Annex A (Informative) Comparison of clause/subclause numbers
Annex B (Informative) List of technical differences and justifications
