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YY 0069-2009 English PDF

YY 0069-2009 English PDF

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YY 0069-2009: Particular requirements for rigid bronchoscopes

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Scope

This Standard specifies scope, terms and definitions, requirements, test
methods, markings, instruction manual and packaging of rigid bronchoscopes.
This Standard applies to rigid bronchoscopes. The product is used for the
examination and diagnosis of the human tracheobronchial internal lumen, and
may be used for treatment in conjunction with the relevant surgical system.

Basic Data

Standard ID YY 0069-2009 (YY0069-2009)
Description (Translated English) Particular requirements for rigid bronchoscopes
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C40
Classification of International Standard 11.040
Word Count Estimation 14,186
Date of Issue 2009-12-30
Date of Implementation 2011-06-01
Older Standard (superseded by this standard) YY 0069-1992
Quoted Standard GB/T 191-2000; YY 0068.1-2008; YY 0068.2-2008; YY 0068.3-2008; YY 0068.4-2008; YY 1040.1-2003
Adopted Standard ISO 8600-2-2002, IDT
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the range of rigid endoscopes trachea, terms and definitions, requirements, test methods, marking, instructions and packaging. This standard applies to the trachea rigid endoscopes. The product is used in human tracheal lumen examination, diagnosis, with the relevant system can be treated with surgery.


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