YY/T 0065-2016 English PDFUS$249.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0065-2016: Ophthalmic instruments-Slit-lamp microscopes Status: Valid YY/T 0065: Historical versions
Basic dataStandard ID: YY/T 0065-2016 (YY/T0065-2016)Description (Translated English): Ophthalmic instruments-Slit-lamp microscopes Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C40 Classification of International Standard: 11.040.70 Word Count Estimation: 11,193 Date of Issue: 2016-01-26 Date of Implementation: 2018-01-01 Issuing agency(ies): State Food and Drug Administration Summary: This standard applies to general-purpose slit lamp microscopes. This standard does not apply to slit lamp microscope accessories, such as photographic equipment and lasers. In case of discrepancies, this standard takes precedence over ISO 15004-1 and ISO 15004-2:2007. YY/T 0065-2016: Ophthalmic instruments-Slit-lamp microscopes---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.ICS 11:040:70 C40 Pharmaceutical Industry Standard of the People's Republic of China YY 0065-2016 Replace YY 0065-2007 Ophthalmic Instruments Slit Lamp Microscope (ISO 10939:2007, MOD) According to the State Drug Administration medical device industry Standard Announcement (No: 76 of 2022), this standard is from From September 7, 2022, it will be converted into a recommended standard, no Enforce it again: 2016-01-26 release:2018-01-01 implementation Issued by China Food and Drug Administration table of contentsPreface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 2 5 Test method 4 6 random files 6 7 mark 7 YY 0065-2016forewordThis standard is drafted in accordance with the rules given in GB/T 1:1-2009: This standard replaces YY 0065-2007 "Ophthalmic Instruments Slit Lamp Microscope": The main technical changes from YY 0065-2007 are as follows: --- Added the requirements for the focal length difference between the left and right viewing systems (see No: 7 in Table 1); --- Added requirements for optical radiation hazards (see 4:4); ---Delete the minimum spot size requirements (2007 version 4:1:3); ---Deleted the requirement for slit spot illumination (2007 edition 4:1:6); ---Deleted the requirement for field of view diameter (2007 edition 4:1:5); ---Deleted the requirements for mechanical movement (4:2 of the:2007 edition); --- Deleted the requirements for environmental testing (2007 edition 4:5): This standard uses the redrafted method to revise and adopt ISO 10939:2007 "Ophthalmic Instruments Slit Lamp Microscope": There are technical differences between this standard and ISO 10939:2007, and the clauses involved in these differences have been adopted in its outer margins: are marked with a single vertical line (|): The technical differences between this standard and ISO 10939:2007 and their reasons are as follows: --- Regarding the normative reference documents, this standard has made adjustments with technical differences to adapt to the technical conditions of our country and the adjustment situation The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows: ● Replace IEC 60601-1 with GB 9706:1, which is equivalent to the international standard; ---In the scope of Chapter 1, add "this standard applies to general-purpose slit lamp microscopes:" --- Increased Chapter 5 test methods: As a recommended test method, it is a method to make the requirements of the standard operable: exist There is no test method in ISO 10939:2007: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents: This standard was proposed by China Food and Drug Administration: This standard is under the jurisdiction of the National Medical Optics and Instruments Standardization Sub-Technical Committee (SAC/TC103/SC1): This standard was drafted by: Zhejiang Medical Device Inspection Institute: The main drafters of this standard: Wang Jingtao, Jia Xiaohang, He Tao, Peng Jianhua: The previous versions of the standards replaced by this part are as follows: ---WS2-285-1982; ---YY 0065-1992; ---YY 0065-2007: YY 0065-2016 Ophthalmic Instruments Slit Lamp Microscope1 ScopeThis standard, together with ISO 15004-1 and ISO 15004-2:2007, specifies the requirements and test methods for slit-lamp microscopy: This standard applies to general-purpose slit lamp microscopes: This standard does not apply to slit lamp microscope accessories, such as photographic equipment and lasers: If there is a difference, this standard takes precedence over ISO 15004-1 and ISO 15004-2:2007:2 Normative referencesThe following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document pieces: For undated references, the latest version (including all amendments) applies to this document: GB 9706:1 Medical Electrical Equipment Part 1: General Safety Requirements (GB 9706:1-2007, IEC 60601-1:1988, IDT) ISO 15004-1 Basic requirements and test methods for ophthalmic instruments - Part 1: General requirements applicable to all ophthalmic instruments (Oph- ISO 15004-2:2007 Basic requirements and test methods for ophthalmic instruments Part 2: Protection against light hazards (Ophthalmicinstru-3 Terms and DefinitionsThe following terms and definitions apply to this document: 3:1 Slit lamp microscope slit-lampmicroscope An instrument consisting of a microscope and a rotating illumination system capable of producing images of the slit: 3:2 When the image is at infinity, when the real object is observed through the magnification system, the viewing angle of the object is the same as that of the human eye when observing the object at a reference viewing distance of 250mm Ratio of viewing angles: Note 1: The calculation formula of viewing angle magnification Γ is as follows: Γ= tanσ' tanσ In the formula: σ'---the angle of observing the object through the center of the entrance pupil of the microscope; σ---The angle at which the human eye observes the same object at a viewing distance of 250mm without any instrument: Note 2: The viewing angle magnification of the microscope is the magnification of the entire system: 3:3 high eye point eyepiece higheyepointeyepiece Eyepieces with high enough pupillary distance for easy wearing of glasses: YY 0065-2016 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0065-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 0065-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0065-2016_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0065-2016_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. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 0065-2016?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0065-2016 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
