YY/T 0634-2022 English PDF

US$329.00 · In stock
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YY/T 0634-2022: (Ophthalmic instruments Fundus camera)
Status: Valid

YY/T 0634: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0634-2022	329	Add to Cart	4 days	(Ophthalmic instruments Fundus camera)	Valid
YY 0634-2008	359	Add to Cart	3 days	Ophthalmic instruments. Fundus cameras	Obsolete

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YY/T 0619   YY 0719.1   YY 0719.2   YY 0792   YY/T 0633   

Basic data

Standard ID: YY/T 0634-2022 (YY/T0634-2022)
Description (Translated English): (Ophthalmic instruments Fundus camera)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C40
Word Count Estimation: 17,147
Issuing agency(ies): State Drug Administration

YY 0634-2008: Ophthalmic instruments. Fundus cameras

---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.
Ophthalmic instruments.Fundus cameras ICS 11.040 C40 People's Republic of China pharmaceutical industry standards Ophthalmic instruments fundus camera (ISO 10940.1998, MOD) Posted 2008-04-25 2009-12-01 implementation State Food and Drug Administration issued

Foreword

5.1.2 This standard is recommended. This revised standard adopts ISO 10940.1998 "fundus camera" (in English). This standard and ISO 10940.1998 The main differences are as follows. a) a supplementary defined-illumination light "color rendering index" and the "camera flash correlated color temperature" requirements; b) updating national mandatory safety standard requirements GB 9706.1 as "electrical safety requirements" indicators; c) The standard ISO 10940.1998 standard referenced in ISO 15004.1997 standard, in addition to optical radiation safety of other content outside Requirements, combined with the applicability of the relevant provisions of the standards were directly described in this standard; d) The standard set forth requirements and test methods for optical radiation safety principles, requirements for optical radiation hazards are not covered. The requirements will be "Ophthalmic instruments for optical radiation safety requirements for" make provision standards. This standard is based on ISO 10940.1998 redrafting changes, modifications and technical differences made have been incorporated into the text in which they are involved Logo | Terms margin of a single vertical line (). This standard by the national medical and optical instruments Standardization Technical Committee and centralized. This standard was drafted. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. JIA Xiao Hang, Wen Yan, Wang Jingtao, He Tao. Ophthalmic instruments fundus camera

1 Scope

This standard specifies the requirements and test methods fundus camera. Fundus camera for fundus photography imaging. This standard does not apply to the following types of fundus camera. --- Sync stereoscopic fundus photography imaging camera; Lighting --- observation system using infrared radiation fundus camera.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 5702-2003 light color evaluation method GB 9706.1-1995 Medical electrical equipment - Part 1. General requirements for safety (idt IEC 601-1. 1988) GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (idt ISO 10993-1.1997) GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests (ISO 10993-5.1999, IDT) GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test (ISO 10993-10.2002, IDT) GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods ISO 15004.1997 basic equipment requirements and test methods Ophthalmology CIE13.3-1995 significant source of color measurement method

3 Terms and Definitions

The following terms and definitions apply to this standard. 3.1 Minimum interval between two adjacent fundus line can be identified, indicating lines per millimeter (lp/mm). 3.2 Viewing angle photography. See Figure 1. 3.3 In the center of the field of photography, fundus target size ratio of the real image and fundus target on the photosensitive target, assuming normal eye condition and In the air in front of the focal length of 17mm. 3.4 Eyepiece sufficient exit pupil distance, wear to meet the mirror frame operates. ......

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