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GB/T 32310-2015: Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results
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Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results
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GB/T 32310-2015
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Basic data | Standard ID | GB/T 32310-2015 (GB/T32310-2015) | | Description (Translated English) | Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.99 | | Word Count Estimation | 32,344 | | Date of Issue | 2015-12-10 | | Date of Implementation | 2016-09-01 | | Adopted Standard | ISO 15882-2008, IDT | | Regulation (derived from) | National Standard Announcement 2015 No.38 | | 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 standard specifies the selection, use and results to determine chemical indicators These chemical indicators used in the definition of the sterilization process, validation and routine monitoring and overall control. This standard chemical indicators by physical and/or chemical change in the substance to display its exposure to the sterilization process, the sterilization process used to monitor one or more variables. These chemical indicators are not dependent on the survival of living organisms or inactivated. | GB/T 32310-2015: Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results
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Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
ICS 11.080.99
C47
National Standards of People's Republic of China
Sterilization of health care products - Chemical indicators -
Selection, use and results to determine Guide
Guidanceforselection, useandinterpretionofresults
(ISO 15882.2008, IDT)
Issued on. 2015-12-10
2016-09-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Preface Ⅰ
1 Scope 1
2 Terms and definitions 1
3 General 2
4 chemical indicators Category 4
5 chemical indicators of choice 8
Using chemical indicators 9 6
Results 7 chemical indicators of judgment 10
8 sterility assurance process chemical indicator 10
9 Training 11
Storage and disposal 10 11
11 identifies 12
(Informative) Background BD test Appendix A 13
Explained in Appendix B (informative) The term "variable" and "parameters" of 15
Annex C (informative) integration requirements indicator of the basic principles and provisions of ISO 11138 with biological indicators performance
And linkages between microbial inactivation (taken from GB 18282.1) 16
Annex D (informative) permeability of 22
Schematic diagram of the components of Appendix E (normative) indicator 24
References 25
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard uses the translation method identical with ISO 15882.2008 "Sterilization of health care products - Chemical indicators selection, use and knot
If the judge's Guide. "
This standard made the following editorial changes.
--- According to GB/T 1.1 requirements of a number of editorial changes;
--- Deleted international standards foreword;
--- Standard texts and part of the international standard reference appearing replace the corresponding country standards.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the National Standardization Technical Committee disinfection technology and equipment (SAC/TC200) centralized.
This standard was drafted. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Beijing Science and Technology Co., Hoagy Italy
Company, Beijing Medical Device Testing.
The main drafters of this standard. Hu Changming, money Yingjie, Liu Pei, the new Mr Wong, Huang Xiulian.
Sterilization of health care products - Chemical indicators -
Selection, use and results to determine Guide
1 Scope
1.1 standard chemical indicators of the selection, use and results provide guidelines judgment, these chemical indicators used in the definition of the sterilization process,
Confirmation and routine monitoring and overall control. This standard chemical indicators by physical and/or chemical change in the substance to display its violent
Exposed to the sterilization process, the sterilization process for monitoring one or more variables. These chemical indicators are not dependent on the survival of living organisms
Or inactivated.
1.2 This standard does not apply to physical removal indicator microorganisms (such as filters) in the process of being used.
1.3 This standard does not apply to the combination process [for example, the cleaning and disinfection or line cleaning (CIP) and online sterilization (SIP) of the composition process]
The indicator used.
2 Terms and definitions
The following terms and definitions apply to this document.
NOTE. ISO /T S11139 [11] provides a set of terms and definitions of health care products sterilization.
2.1
Chemical indicators chemicalindicator
Non-biological indicators non-biologicalindicator
Depending on the chemical or physical change in exposure to a sterilization process produced, showing a plurality of predetermined changes in process variables or tests
system.
[ISO /T S11139.2006, the definition 2.6]
2.2
Endpoint endpoint
Observable change point defined by the manufacturer of the indicator after exposure to a predetermined calibration value appears.
[GB 18282.1-2015, the definition 3.3]
2.3
Indicator indicator
Indicator to its final application substrate to form a combination.
[GB 18282.1-2015, the definition 3.5]
Note 1. The composition indicator system and special test load is also defined as the indicator.
Note 2. Appendix E.
2.4
Indicator indicatoragent; indicatorreagent
Combination of active substance or active substances.
[GB 18282.1-2015, the definition 3.6]
Note. See Appendix E.
2.5
Process challenge device processchalengedevice; PCD
Constituted of a specific resistance of the sterilization process means for evaluating the performance of the sterilization process.
[ISO /T S11139.2006, definitions 2.33]
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