YY 0673-2008 English PDF

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YY 0673-2008: Opthalmic instruments. Eye refractometers

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0673-2008	279	Add to Cart	3 days	Opthalmic instruments. Eye refractometers

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Basic data

Standard ID: YY 0673-2008 (YY0673-2008)
Description (Translated English): Opthalmic instruments. Eye refractometers
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C40
Classification of International Standard: 11.040.70
Word Count Estimation: 8,855
Date of Issue: 2008-10-17
Date of Implementation: 2010-06-01
Quoted Standard: GB 9706.1-2007; GB/T 14710-1993; GB/T 16886.1-2001; GB/T 16886.5-2003; GB/T 16886.10-2005; ISO 7944-1998; ISO 8429-1986; ISO 15004-1997
Adopted Standard: ISO 10342-1997, MOD
Regulation (derived from): SFDA [2008] No. 605
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the requirements and test methods refractor.

YY 0673-2008: Opthalmic instruments. Eye refractometers

---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.
Opthalmic instruments.Eye refractometers ICS 11.040.70 C40 People's Republic of China pharmaceutical industry standards Ophthalmic instruments refractometer (ISO 10342.1997, MOD) Posted 2008-10-17 2010-06-01 implementation State Food and Drug Administration issued

Foreword

This revised standard adopts the International Standard ISO 10342.1997 "ophthalmic instruments refractometer." This standard and ISO 10342.1997 international standard main differences are as follows. a) updating national mandatory safety standard requirements GB 9706.1 as "electrical safety requirements" indicators; b) to ISO 10342. ISO 15004 1997 standard referenced in.1997 standard content, in this standard, in addition to optical radiation safety content 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 10342.1997 after the re-drafting 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 normative appendix. 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, Wen Yan, JIA Xiao Hang, He Tao. Ophthalmic instruments refractometer

1 Scope

This standard specifies the requirements and test methods refractometer.

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 601-1. 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 7944.1998 Optics and optical instruments - Reference wavelengths 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. Or a continuous digital readout for measuring eye refractive error of the instrument.

4 Requirements

4.1 General requirements Refractometer shall meet the appropriate requirements for optical radiation safety standards. 4.2 Optical Requirements Refractometer should be consistent with Table 1 or Table 2 requirements. Refractive power requirement should be given in ISO 7944.1998 requirements of the reference wavelength λ = 546.07nm or λ = 587.56nm. If these two wavelengths can not meet the requirements, you should specify the reference wavelength. Cylinder of representation should be as usual using the "+" or "-." Table 1 requires continuous display refractor Measuring range maximum width spacing accuracy --- two standard deviations project content Spherical and cylinder vertex 0.00D ~ ± 10.00D 0.25D ± 0.25D > | ± 10.00D | 0.50D ± 0.50D ......

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