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YY 0674-2008 English PDF

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YY 0674-2008: Ophthalmic instruments. Refractor heads

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY 0674-2008	English	389	Add to Cart	3 days [Need to translate]	Ophthalmic instruments. Refractor heads		YY 0674-2008

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Basic data

Standard ID	YY 0674-2008 (YY0674-2008)
Description (Translated English)	Ophthalmic instruments. Refractor heads
Sector / Industry	Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard	C40
Classification of International Standard	11.040.70
Word Count Estimation	11,172
Date of Issue	2008-10-17
Date of Implementation	2010-06-01
Quoted Standard	GB 9706.1; GB/T 10050-1988; GB/T 14710-1993; GB/T 16886.5-2003; GB/T 16886.10-2005; ISO 8429-1986; ISO 15004-1997
Adopted Standard	ISO 10341-1997, MOD
Regulation (derived from)	SFDA [2008] No. 605
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard provides for the measurement of the human eye refractive errors and binocular vision optometry head requirements and test methods.

YY 0674-2008: Ophthalmic instruments. Refractor heads

---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.Refractor heads ICS 11.040.70 C40 People's Republic of China pharmaceutical industry standards Ophthalmic instruments optometry head (ISO 10341.1997, MOD) Posted 2008-10-17 2010-06-01 implementation State Food and Drug Administration issued

Foreword

This revised standard adopts the International Standard ISO 10341.1997 "ophthalmic instruments optometry head." This standard and ISO 10341.1997 The main differences are as follows. a) This standard ISO 15004.1997 standard 4.4 material requirements, modifications incorporated this standard 4.4 requirements; b) This standard ISO 15004.1997 standard 4.5, adding a reference to the present requirements of the standard 4.5; c) Environmental requirements and test methods for the use of the relevant provisions of GB/T 14710-1993 of; d) require the use of safety requirements GB 9706.1. This standard is based on ISO 10341.1998 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 (). Appendix A of this standard is an informative annex. This standard by the National Standardization Technical Committee of medical and optical instruments and optical instruments at the 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. Drafters of this standard. Wen Yan, JIA Xiao Hang, Wang Jingtao, He Tao, Qi Weiming, Mary. Ophthalmic instruments optometry head

1 Scope

This standard gives requirements and test methods for measuring the human eye binocular vision and refractive errors optometry head.

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 Medical Electrical Equipment Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601. 1988, IDT) GB/T 10050-1988 and optical equipment reference wavelength (eqv ISO 7944. 1984) GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods 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 8429. 1986 Optics and optical instruments - Ophthalmology dial ISO 15004.1997 ophthalmic instruments basic requirements and test methods

3 Terms and Definitions

The following terms and definitions apply to this standard. 3.1 To provide spherical lenses, cylinder lenses and a prism sheet and other optics equipment can be placed in front of people measure the patient's binocular vision and Qu Light errors. 3.2 Head for measuring the refraction power of tolerance of positioning plane. 3.3 Optometry head reference plane and the distance between the corneal vertex. 3.4 The intersection of the optical axis of the lens on the lens surface. 3.5 Lenses and optical surfaces by changing the curvature or refraction through the ability to change the direction of the incident surface.

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