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YY/T 0633-2022: Ophthalmic instruments - Indirect ophthalmoscopes
Status: Valid YY/T 0633: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0633-2022 | English | 179 |
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Ophthalmic instruments - Indirect ophthalmoscopes
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YY/T 0633-2022
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| YY 0633-2008 | English | 319 |
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Ophthalmic instruments. Indirect ophthalmoscopes
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YY 0633-2008
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PDF similar to YY/T 0633-2022
Basic data | Standard ID | YY/T 0633-2022 (YY/T0633-2022) | | Description (Translated English) | Ophthalmic instruments - Indirect ophthalmoscopes | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Word Count Estimation | 8,848 | | Date of Issue | 2022-10-17 | | Date of Implementation | 2023-10-01 | | Older Standard (superseded by this standard) | YY/T 0633-2008 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the minimum requirements and test methods for hand-held, glasses-type and head-mounted indirect ophthalmoscopes for observing indirect fundus images. This standard applies to hand-held, glasses-type and head-mounted indirect ophthalmoscopes. This standard does not apply to condenser lenses and accessories for indirect ophthalmoscopes. This standard does not apply to table-mounted instruments, nor does it apply to ophthalmoscopes primarily used for image capture and/or image processing, such as ophthalmoscopes using scanning laser technology. | YY 0633-2008: Ophthalmic instruments. Indirect ophthalmoscopes---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.Indirect ophthalmoscopes
ICS 11.040
C40
People's Republic of China pharmaceutical industry standards
Indirect ophthalmoscope ophthalmic instruments
(ISO 10943.1998, MOD)
Posted 2008-04-25
2009-12-01 implementation
State Food and Drug Administration issued
Foreword
5.1.6,5.1.9 this standard is recommended.
This revised standard adopts ISO 10943.1998 "indirect ophthalmoscope ophthalmic instruments" (in English).
This standard and ISO 10943.1998 standard main differences are as follows.
a) supplements the illumination light outgoing "CRI" definitions and requirements;
Recommended methods;
c) complements the national mandatory safety standard requirements of GB 9706.1-1995 as "electrical safety requirements" indicators, as this standard
4.9 requirements;
d) The standard ISO 10943.1998 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;
e) 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 10943.1998 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, Wang Jingtao, Wen Yan, He Tao.
Indirect ophthalmoscope ophthalmic instruments
1 Scope
This standard specifies the basic requirements and test methods for hand-held mirror frame and headset indirect ophthalmoscope.
This standard does not apply to indirect ophthalmoscope with a condenser and its accessories.
This standard does not apply to fixed instruments such as countertops Gulstrand ophthalmoscope and such derivative instruments are not suitable for image capture and/or
Processing ophthalmoscope, such as the use of laser scanning technology ophthalmoscope like.
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 (idt ISO 10993-5.
1999)
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test
(Idt ISO 10993-10.2002)
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
To check the eyes and especially the eye fundus and media (handheld or integral) is generated by one by a condenser lens can be visually observed
The intermediate real image optical instruments.
3.2
In order to be properly converging directly into the patient's eye, the instrument provides a lighting system and the use of a condenser lens (handheld or whole
Formula) monocular observation ophthalmoscope.
NOTE. For the intermediate visual condenser to produce a real image can better focus, this instrument may include corrective lenses or eyepiece.
3.3
In order to be properly converging directly into the patient's eye, the instrument provides a lighting system and the use of a condenser lens (handheld or whole
Formula) binocular ophthalmoscope.
Note 1. This instrument also includes an observation system which allows binocular condenser generated intermediate real image, on the retina of the patient visual
an examination.
Note 2. In order to help focus the visual image observation, this instrument may include corrective lenses or eyepiece.
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