GB 18282.3-2009: Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

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Scope

This Part of GB 18282 specifies the requirements for chemical indicators to be used in the
steam penetration test for steam sterilizers for wrapped goods, e.g., instruments and porous
materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.
Indicators complying with this Part of GB 18282 are intended for use in combination with the
standard test pack as described in EN 285. This Part of GB 18282 does not consider the
performance of the standard test pack, but does specify the performance of the indicator systems.

Basic Data

Standard ID	GB 18282.3-2009 (GB18282.3-2009)
Description (Translated English)	Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
Sector / Industry	National Standard
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	22,216
Date of Issue	2009-11-15
Date of Implementation	2010-12-01
Quoted Standard	GB/T 11501; GB/T 12823.1; GB/T 12823.4-2008; ISO 187-1990; ISO 2248; ISO 5457; ISO 5636-3; ISO 11140-1-2005; ISO/CIE 10526-1999; EN 285-2006
Adopted Standard	ISO 11140-3-2007, IDT
Regulation (derived from)	Announcement of Newly Approved National Standards No. 13 of 2009 (No. 153 overall)
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This Chinese standard provides for the packaging (such as equipment) and porous load sterilization Yan steam sterilizer steam penetration test chemical indicators used in the request. The indicator for this purpose is described in ISO 11140-1 Class 2 indicator. Meet the requirements of this standard of GB 18282 The indicator should be combined with the standard meet the requirements of EN 285 test kit used in conjunction. GB 18282 of this standard of the standard test pack performance would not be considered only as a performance indicator system requirements.