YY/T 0454-2008: Disposable scalpel

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Scope

This standard specifies the structure and marking, requirements, test methods,
inspection rules, signs, packaging, transportation, storage, use period of disposable
scalpels.
This standard applies to disposable scalpels (hereinafter referred to as scalpels), in
sterile packaging for single use, which are used to cut soft tissue, during surgery or
dissection.

Basic Data

Standard ID	YY/T 0454-2008 (YY/T0454-2008)
Description (Translated English)	Disposable scalpel
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.30
Word Count Estimation	12,132
Date of Issue	2008-10-17
Date of Implementation	2010-01-01
Older Standard (superseded by this standard)	YY/T 0454-2003
Quoted Standard	GB/T 1220-2007; GB/T 1298-1986; GB/T 1299-2000; GB/T 2828.1-2003; GB/T 16886.7-2001; YY/T 0171-2008; YY 0174-2005; YY/T 0466-2003
Regulation (derived from)	SFDA [2008] No. 605
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the structure of a sterile scalpel with plastic handle and marking, requirements, test methods, inspection rules, marking, packaging, transportation, storage, use period. This standard applies to single-use sterile sterile packaging plastic handle scalpel (hereinafter referred to as a scalpel), the product is a surgical or anatomical when cutting soft tissues.