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 (English Version)

Standard No.

GB 18282.4-2009

Language

Chinese, Available in English version

Release Date

2009

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB 18282.4-2009

Scope

This part of GB 18282 specifies the performance requirements for the second-class indicator, which can be used in the BD-type test for steam sterilizers for sterilization of medical care packaging products (such as instruments and porous loads, etc.). For optional use. Indicators complying with the requirements of this part of GB 18282 incorporate a special material as a test load. The test load can be used once or repeatedly. This part of GB 18282 has no requirements on the test load, but specifies the performance requirements of indicators combined with special test loads. Indicators that meet the requirements of this part of GB 18282 can be used to confirm insufficient steam penetration, but do not need to indicate the cause. This standard does not contain test methods to confirm the applicability of this indicator system to sterilizers without negative pressure exhaust process.

GB 18282.4-2009 Referenced Document

• EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers (Incorporates Amendment A2: 2009)
• GB/T 11501 Photography.Density measurement.Part 3:Spectral conditions
• 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
• GB/T 16839.2-1997 Thermocouples--Part 2: Tolerances
• IEC 60751:1983 Industrial platinium resistance thermometer sensors
• ISO 10012-1 Quality assurance requirements for measuring equipment; part 1: metrological confirmation system for measuring equipment
• 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/CIE 10526:1999 CIE standard illuminants for colorimetry

GB 18282.4-2009 history

• 2009 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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