GB 18282.4-2009: Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

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Scope

This Part of GB 18282 specifies the performance for a Class 2 indicator to be used as an
alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods
(instruments, etc., and porous loads).

Basic Data

Standard ID	GB 18282.4-2009 (GB18282.4-2009)
Description (Translated English)	Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
Sector / Industry	National Standard
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	30,397
Date of Issue	2009-11-15
Date of Implementation	2010-12-01
Quoted Standard	GB/T 11501; GB/T 12823.1; GB/T 12823.4-2002; GB/T 16839.2-1997; ISO 2248; ISO 10012-1; ISO/CIE 10526-1999; IEC 60584-2/AMD 1-1986; IEC 60751-1983; IEC 60751/AMD 1-1986; EN 285-2006; ISO 187-1990; ISO 11140-1-2005
Adopted Standard	ISO 11140-4-2007, 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 specifies performance requirements for Class 2 indicator in the healthcare packaging products (eg instruments and porous loads, etc.) with a steam sterilizer for sterilizing a BD class tests, the two types of indicators can be choose to use. This standard of GB 18282 specifies performance requirements for Class 2 indicator in the healthcare packaging products (eg instruments and porous loads, etc.) with a steam sterilizer for sterilizing a BD class tests, the two types of indicators can be choose to use. Meet the requirements of this standard of GB 18282 binding instructions have a special material as the test load. Test load can be one-time use, it can be reused. GB 18282 this standard of the test load is not a requirement, but provides a combination of a dedicated test load indicator of performance requirements. Meet the requirements of this standard of GB 18282 indicator of insufficient steam penetration can be used to confirm, but need to specify its causes. This standard does not contain confirm this indicator vacuum exhaust system without sterilization process is applicable testing methods.