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YY 0676-2008 English PDF

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YY 0676-2008: Opthalmic instruments. Perimeters
Status: Obsolete
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Basic data

Standard ID YY 0676-2008 (YY0676-2008)
Description (Translated English) Opthalmic instruments. Perimeters
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C40
Classification of International Standard 11.040.70
Word Count Estimation 14,152
Date of Issue 2008-10-17
Date of Implementation 2010-06-01
Adopted Standard ISO 12866-1999, MOD
Regulation (derived from) SFDA [2008] No. 605
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the perimeter of the requirements and test methods. Perimeter is designed to subjectively perceived through the context of a trial to determine the presence of stimulation points to evaluate vision light sensitivity is poor. This standard does not apply to clinical methods and psychology field test methods.

YY 0676-2008: Opthalmic instruments. Perimeters

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Opthalmic instruments.Perimeters ICS 11.040.70 C40 People's Republic of China pharmaceutical industry standards Ophthalmic instruments perimetry (ISO 12866.1999, MOD) Posted 2008-10-17 2010-06-01 implementation State Food and Drug Administration issued

Table of Contents

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions Requirement 3 4 Test Method 5 5 6 7 accompanying documents 7 7 mark Appendix A (Informative Appendix) Goldmann test prescribed stimulation points 8 Annex B (informative) visual field coordinate system 10

Foreword

This revised standard adopts the International Standard ISO 12866.1999 "ophthalmic instruments perimeter." This standard and ISO 12866.1999 The main differences are as follows. a) updating national mandatory safety standard requirements GB 9706.1 as "electrical safety requirements" indicators; b) to ISO 10940. ISO 15004 1998 standard referenced in.1997 standard content, in addition to optical radiation security content of this standard In addition, combined with other requirements of the relevant standards applicability of provisions made directly described in this standard. 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 (). The Standard Appendix A, Appendix B is an informative annex. This standard by the National Standardization Technical Committee and optical instruments and medical optical instruments Technical Committee (SAC/TC103 / SC1) and focal points. This standard was drafted. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Wang Jingtao, JIA Xiao Hang, He Tao, Qi Weiming. Ophthalmic instruments perimetry

1 Scope

This standard specifies the requirements and test methods of perimetry. Perimeter is designed to lower perceived by a subjective test to determine the background thorn The presence of trigger points to evaluate vision light sensitivity difference. This standard does not apply to clinical psychology test methods and methods for vision.

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 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods 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) ISO 15004.1997 basic equipment requirements and test methods Ophthalmology

3 Terms and Definitions

The following terms and definitions apply to this standard. 3.1 Eyes set moment in time to perceive stimuli visible in all directions and the response to these stimuli perception. 3.1.1 Field of view when viewed with one eye. 3.1.2 Perspective with both eyes when viewed. 3.1.3 Expanded from solid point of view to all horizons within 30 ° range. 3.1.4 All horizons beyond solid point of view 30 ° range. NOTE. To distinguish between central and peripheral visual field full field. 3.2 By examining the performance of the stimulus on a certain background to evaluate the visual field light sensitivity difference instruments.

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