GB/T 11239.1-2025 English PDFUS$409.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 11239.1-2025: Optics and photonics - Operation microscopes - Part 1: Requiremnts and test methods Status: Valid GB/T 11239.1: Historical versions
Basic dataStandard ID: GB/T 11239.1-2025 (GB/T11239.1-2025)Description (Translated English): Optics and photonics - Operation microscopes - Part 1: Requiremnts and test methods Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C40 Classification of International Standard: 11.040.70 Word Count Estimation: 20,265 Date of Issue: 2025-06-30 Date of Implementation: 2027-07-01 Older Standard (superseded by this standard): GB 11239.1-2005 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 11239.1-2025: Optics and photonics - Operation microscopes - Part 1: Requiremnts and test methods---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT11239.1-2025 ICS 11.040.70 CCSC40 National Standard of the People's Republic of China Replaces GB 11239.1-2005 Optical and Photonics Surgical Microscopes Part 1.Requirements and test methods (ISO 10936-1.2017,MOD) Released on June 30, 2025 Implementation on July 1, 2027 State Administration for Market Regulation The National Standardization Administration issued Table of ContentsPreface III Introduction V 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 1 5 Test Method 3 6 Mark 9 Appendix A (Informative) Structure Number Comparison Table 10 Appendix B (Informative) List of Technical Differences and Their Causes 12 Reference 14 Preface This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document is Part 1 of GB/T 11239 Optical and Photonic Surgical Microscopes. GB/T 11239 has been published for the following part. --- Part 1.Requirements and test methods. This document replaces GB 11239.1-2005 "Operating microscopes Part 1.Requirements and test methods" and is consistent with GB 11239.1-2005. In addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Deleted the term and definition of "working distance" (see 3.1.2 of the.2005 edition); --- Deleted the classification (see 3.2 of the.2005 edition); --- Changed "the field of view between the left and right optical systems should be consistent" (see Table 1, 4.2.1 of the.2005 edition); --- Added the requirement of "the amount of movement of the parfocal plane when changing the magnification" (see 4.2); --- Deleted the "Environmental requirements" requirement (see 4.4 of the.2005 edition); --- Changed the requirement of "Conversion of temperature rise of the illuminated surface into irradiance" (see 4.7, 4.2.6 of the.2005 edition); --- Added "electromagnetic compatibility" requirements (see 4.12); --- Deleted the inspection rules (see Chapter 5 of the.2005 edition); --- Added the test method of "axial difference between left and right optical systems" (see 5.2.3.3); --- Added the test method of "the amount of movement of the focal plane when changing the magnification" (see 5.2.3.4); --- Added the "electromagnetic compatibility" test method (see 5.12); --- Added "marking" requirements (see Chapter 6); --- Deleted temperature and relative humidity conditions (see 6.1 of the.2005 edition); --- Deleted the "Environmental test" test method (see 6.12 of the.2005 edition); --- Deleted the signs, labels and instruction manual (see Chapter 7 of the.2005 edition); --- Deleted packaging, transportation and storage (see Chapter 8 of the.2005 edition). This document modifies ISO 10936-1.2017 "Optical and photonic surgical microscopes — Part 1.Requirements and test methods". Compared with ISO 10936-1.2017, this document has many structural adjustments. The structural number changes between the two documents are shown in the table below. See Appendix A for the table. This document has many technical differences compared to ISO 10936-1.2017. A list of these technical differences and their reasons is given in Appendix B. The following editorial changes have been made to this document. --- Deleted the URLs of ISO and IEC terminology databases in Chapter 3. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Optics and Photonics (SAC/TC103). This document was drafted by. Zhejiang Medical Device Inspection Institute, Carl Zeiss (Shanghai) Management Co., Ltd., Leica Microsystems (Shanghai) Trading Co., Ltd., Suzhou Liuliu Vision Technology Co., Ltd., and Suzhou Sumai Medical Technology Co., Ltd. The main drafters of this document are. Wang Jingtao, Peng Jianhua, Hu Yiping, Huang Tao, Wang Jianshu, Lu Jingping, Wang Hanxiang, Wang Jilong, Wang Jiajia, Xia Zhongcheng, Lu Nan, Wang Tianjiao, Sun Hui, Li Jianyue. The previous versions of this document and the documents it replaces are as follows. --- First issued as GB 11239-1989 in 1989, first revised in.2005;introductionGB/T 11239 “Optical and photonic surgical microscopes” is intended to consist of two parts. --- Part 1.Requirements and test methods. The purpose is to establish general requirements and test methods that need to be followed for all types of surgical microscopes. Test method. --- Part 2.Light hazards of ophthalmic surgical microscopes. The purpose is to establish the light hazard requirements applicable to ophthalmic surgical microscopes. Requirements and test methods to be followed. Optical and Photonics Surgical Microscopes Part 1.Requirements and test methods 1 Scope This document specifies the requirements for surgical microscopes and describes the corresponding test methods. This document applies to surgical microscopes used for observation during surgical procedures and patient care. This document does not apply to surgical microscope accessories, such as camera systems. NOTE. ISO 10936-2 specifies specific requirements for optical radiation hazards associated with ophthalmic surgical microscopes. 2 Normative references The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance (GB 9706.1-2020, IEC 60601-1.2012, 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 Resolution Plate YY9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and essential performance Collateral standard. Electromagnetic compatibility Content requirements and tests 3 Terms and Definitions The following terms and definitions apply to this document. 3.1 operating microscope Stereo microscopes for observing surgical and other medical procedures, consisting of an illumination system and an observation system (including objectives, variable or fixed It consists of a magnification optical system, an observation tube and an eyepiece. Example. colposcopy. 4 Requirements 4.1 General requirements The surgical microscope should meet the requirements of 4.2 to 4.12. All the following requirements are minimum requirements. The reference wavelength complies with the provisions of GB/T 10050. 4.2 Optical and mechanical requirements Surgical microscopes should comply with the requirements specified in Table 1. The tests for optical and mechanical requirements shall be carried out in accordance with 5.2. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 11239.1-2025_English be delivered?Answer: Upon your order, we will start to translate GB/T 11239.1-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 11239.1-2025_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 11239.1-2025_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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