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YY 0065-2016 English PDF

YY 0065-2016 English PDF

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YY 0065-2016: Ophthalmic instruments - Slit-lamp microscopes

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Scope

This standard, together with ISO 15004-1 and ISO 15004-2.2007, specifies the
requirements and test methods for slit-lamp microscopes.
This standard applies to universal slit-lamp microscopes. This standard does
not apply to slit-lamp microscope accessories, such as camera equipment and
lasers. If there are differences, this standard takes precedence over ISO
15004-1 and ISO 15004-2.2007.

Basic Data

Standard ID YY 0065-2016 (YY0065-2016)
Description (Translated English) Ophthalmic instruments - Slit-lamp microscopes
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C40
Classification of International Standard 11.040.70
Word Count Estimation 11,171
Date of Issue 1/26/2016
Date of Implementation 2018-01-01
Older Standard (superseded by this standard) YY 0065-2007
Quoted Standard GB 9706.1; ISO 15004-1; ISO 15004-2-2007
Adopted Standard ISO 10939-2007, MOD
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the requirements and test methods for the slit lamp. This standard applies to general-purpose slit lamp. This standard does not apply to slit lamp microscope accessories, such as photographic equipment and lasers. If there is a difference, this standard takes precedence over ISO 15004-1 and ISO 15004-2-2007.


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