GB 18282.1-2015 English PDF (GB18282.1-2015)

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GB 18282.1-2015: Sterilization of health care products -- Chemical indicator -- Part 1: General requirements
GB 18282.1-2015
Sterilization of health care products - Chemical indicator - Part 1. General requirements
ICS 11.080.01
C47
National Standards of People's Republic of China
Replacing GB 18282.1-2000
Sterilization of health care products - Chemical indicators -
Part 1. General
Part 1. Generalrequirements
(ISO 11140-1.2005, IDT)
Issued on. 2015-12-10
2017-01-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Preface Ⅰ
Introduction Ⅱ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 Category 2
5 General requirements 3
Performance Requirements 4 6
Test Method 5 7
Additional requirements 8 process (a class) indicator 7
9 univariate (three) additional indicator of claim 9
Additional requirements for more than 10 variables (four categories) indicator 10
11 Steam Integration (five) additional indicator of claim 10
12 dry heat integration (five) additional indicator of claim 11,
13 Integration of ethylene oxide (five) additional indicator of claim 11,
Additional requirements 14 analog (six) indicator 12
Appendix A (informative) to prove the validity of the product 13
Examples Appendix B (informative) Test indicator 14
Requirements Annex C (informative) indicator of integration requirements and principles of ISO 11138 and the provisions of the biological indicators
And relevance of inactivation of microorganisms 15
Annex D (informative) formaldehyde vapor phase indicator Test Method Principle 20
21 relationship between the composition of Appendix E (normative) indicator
References 22
Foreword
All technical content in this Part of GB 18282 is mandatory.
GB 18282 "Sterilization of health care products - Chemical indicators" is divided into the following sections.
--- Part 1. General;
--- Part 3. Class 2 indicator systems for BD type steam penetration test;
--- Part 4. Class for alternative BD steam penetration test Class 2 indicators;
--- Part 5. BD class for air removal test two types of indicators.
NOTE. GB 18282.2 "Sterilization of health care products - Chemical indicators - Test equipment and methods" were GB/T 24628-2009 "Sterilization of health care products
Biological and chemical indicators of test equipment "instead.
This is Part 1 GB 18282's.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This Part replaces GB 18282.1-2000 "Sterilization of health care products - Chemical indicators - Part 1. General", and GB 18282.1-
Compared to 2000, the main differences are as follows.
--- Gradual increase of the reaction, the indicator system, offset, penetration, substrate, visible changes in the terms and definitions;
--- Added "vaporized hydrogen peroxide" sterilization process indicator key parameters of the request;
--- Increased Chapter 6 Test Method for indicator performance requirements and Chapter 7 of the indicator;
--- Increase in the content of Appendix E Appendix A ~.
This part identical with ISO 11140-1.2005 "Sterilization of health care products - Chemical indicators - Part 1. General."
Consistency correspondence between this part of international documents and normative references of our files are as follows.
--- GB/T 7408-2005 data elements and interchange formats - Information interchange dates and times (ISO 8601.2000,
IDT);
--- GB 18281 (all parts) Sterilization of health care products - Biological indicators [ISO 11138 (all parts)];
--- GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1. materials, sterile barrier systems and packaging lines
System Requirements (ISO 11607-1.2006, IDT);
Confirm forming, sealing and assembly processes. --- GB/T 19633.2-2015 final packaging sterilized medical devices - Part 2
Requirements (ISO 11607-2.2006, IDT);
--- GB/T 24628-2009 Sterilization of health care products biological and chemical indicators of test equipment (ISO 18472.2006,
IDT).
This part made the following editorial changes.
--- Deleted international standards foreword;
--- Introduction of international standards and references appear to 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 part is proposed by the China Food and Drug Administration.
This part of the National Standardization Technical Committee disinfection technology and equipment (SAC/TC200) centralized.
This section drafted by. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Beijing Science and Technology Co., Hoagy Italy
The company, Shandong Xinhua Medical Instrument Co., Ltd.
The main drafters of this section. Wu Weirong, publicity, money Yingjie, Wang Hongmin.
This part of the standard replaces the previous editions are.
--- GB 18282.1-2000.
introduction
This part of GB 18282 specifies performance requirements and chemical indicators (or) test method is intended for chemical indicators of steam, dry heat,
Ethylene oxide, γ and β radiation, steam, formaldehyde or vaporized hydrogen peroxide sterilization process test.
For this section does not specifically provide for the expected indicators (eg other forms of moist heat sterilization) other sterilization methods of additional requirements,
General requirements of this section shall apply.
For specific test indicators (such as BD test indicator) requirements include other parts of GB 18282.
For sterilizers and sterilization standards for process control and acknowledgment, describe the sterilizer performance testing and validation and routine control
method.
This section is intended for manufacturers of chemical indicators, and provides instructions General chemical substance. Then part of GB 18282 specifies the special
PURPOSE chemical indicators, as well as specific requirements for medical products, including industry-specific sterilization process testing, this Part
Use of chemical indicators, described in ISO 15882, EN285, GB 18279 and ISO 17665 in.
Resistance meter (see ISO 18472) for the characterization described in this section of chemical indicators. Resistance instrument allows specific test conditions and
Exact change cycle results in the formation of a controlled physical studies. Resistance meter with a conventional sterilizer different, so if the conventional sterilizer
Used to try to repeat the resistance instrument conditions, errors and (or) misleading results may occur.
Sterilization of health care products - Chemical indicators -
Part 1. General
1 Scope
1.1 GB 18282 of the provisions of this part of the indicators - General requirements and test methods, these indicators are by physical and/or chemical substance
Matter changes to display its exposure to the sterilization process, and for monitoring to obtain predetermined single or multiple sterilization process parameters, they do not rely on micro
Biological survival or deactivation.
NOTE. The system relies on biological testing to prove the viability of the organism to be tested. About the class, the test system should be ISO 11138 series of biological means
It was shown (BIs) involved.
1.2 Requirements and Test Methods section GB 18282 applies to all other parts of the indicator stipulated, among other parts of the modified or increased
Canadian requirements, the specific requirements of Part This situation will apply.
Associated test...