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YY 1080-2009Ophthalmic instruments - Direct ophthalmoscopes (English PDF)

眼科仪器直接检眼镜

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

December 30, 2009

Implementation date

June 1, 2011

Scope

YY 1080-2009 is the English-translated version of 眼科仪器直接检眼镜.

YY 1080-2009 is a mandatory Chinese medical device and pharmaceutical industry standard in the ophthalmic instruments series, covering direct ophthalmoscopes. It gives the requirements and the test methods for the hand held direct ophthalmoscope, the instrument used to examine the fundus and the refractive media of the eye.

The standard is a modified adoption of ISO 10942:2006 and cites GB 9706.1-2007, GB 17341, GB/T 5702, GB/T 14710 and ISO 15004:1997. It replaces YY 91080-1999, the earlier standard for the same instrument.

It was issued by the State Food and Drug Administration under ICS 11.040.70 and Chinese classification C40. Issued on 30 December 2009, it has applied since 1 June 2011.

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Document preview — YY 1080-2009

National Standard of the People's Republic of China

ICS: 11.040.70
Replacing: YY 91080-1999

Issued by: National Medical Products Administration of the People's Republic of China

1 Foreword

YY 1080-2009 was issued by National Medical Products Administration of the People's Republic of China on 30 December 2009 and has been in force since 1 June 2011.

2 Scope

This standard is a mandatory Chinese medical device and pharmaceutical industry standard in the ophthalmic instruments series, covering direct ophthalmoscopes. It gives the requirements and the test methods for the hand held direct ophthalmoscope, the instrument used to examine the fundus and the refractive media of the eye. The standard is a modified adoption of ISO 10942:2006 and cites GB 9706.1-2007, GB 17341, GB/T 5702, GB/T 14710 and ISO 15004:1997. It replaces YY 91080-1999, the earlier standard for the same instrument.040.70 and Chinese classification C40.

3 Normative references

YY 1080-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.

GB 9706.1-2007

GB 17341

GB/T 5702

GB/T 14710

ISO 15004-1997

4 About this standard

Issued by: National Medical Products Administration of the People's Republic of China

English translation: about 15 pages

5 Classification and status

International classification (ICS): 11.040.70

Prefix YY: mandatory standard.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 15004-1997

Similar standards

YY 0633-2008|YY 0792-2024|YY 0065-2016|YY 0792.1-2016|YY 0787-2010|YY 0788-2010

Editions of YY 1080

Edition	Title	Revision	Status
YY 1080-2009	Ophthalmic instruments - Direct ophthalmoscopes	current edition	Current
YY 91080-1999	Ophthalmic instruments - Direct ophthalmoscopes	previous edition	Superseded

This page sells the current edition, YY 1080-2009. Earlier editions are listed for reference only.

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