YY 0091-2013: Cervix dilator

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Scope

This Standard specifies the structural type and material, technical requirements, test
methods, inspection rules, marking, packaging, transportation, and storage of cervix
dilator.
This Standard applies to cervix dilator (hereinafter referred to as dilator). This product
is used in obstetrics and gynecology to dilate the cervix.
This Standard does not apply to disposable cervix dilator.

Basic Data

Standard ID	YY 0091-2013 (YY0091-2013)
Description (Translated English)	Cervix dilator
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C36
Classification of International Standard	11.040.30
Word Count Estimation	10,111
Older Standard (superseded by this standard)	YY 0091-1992
Quoted Standard	GB/T 1220; GB/T 1527; GB/T 2828.1; GB/T 2829; GB/T 6463; GB/T 10610; YY 0076-1992; YY/T 0149-2006; YY/T 0171-2008; YY/T 1052
Regulation (derived from)	State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the structure type and material, technical requirements, test methods, inspection rules cervical dilators, logos, packaging, transportation and storage. This standard applies to cervical dilator (hereinafter referred to as the dila