GB 18282.3-2009 Sterilization of health care products-Chemical indicators-Part3:Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (English Version)
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
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GB 18282.3-2009
Scope
This part of GB 18282 specifies the requirements for chemical indicators used in the steam sterilizer steam penetration test for packaged and porous load sterilization. The indicator used for this purpose is the second type indicator described in ISO 11140-1. Indicators that meet the requirements of this part of GB 18282 should be used in conjunction with standard test packages that meet the requirements of EN 285. This part of GB 18282 does not consider the performance of the standard test package, but only requires the performance of the indicator system.
GB 18282.3-2009 Referenced Document
EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers (Incorporates Amendment A2: 2009)
GB/T 12823.1 Photography.Denstiy measurement.Part 1:Terms,symbols and notations
GB/T 12823.4-2008 Photography.Density Measurement.Part 4:Geometric conditions for reflection density
ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 187:1990 Paper, board and pulps; standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ISO 2248 Packaging; Complete, filled transport packages; Vertical impact test by dropping
ISO 5457 Technical product documentation — Sizes and layout of drawing sheets AMENDMENT 1
ISO 5636-3 Paper and board.Determination of air permeance (medium range) .Part 3: Bendtsen method*, 2013-11-01 Update
2009GB 18282.3-2009 Sterilization of health care products-Chemical indicators-Part3:Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test