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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 ???
Introduction ???
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, ?? and ?? 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 equipment described in ISO 18472.
Note. The specific test indicators (II) Additional requirements GB 18282.3, GB 18282.4 and GB 18282.5 given in.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
ISO 8601 Data elements and interchange formats - Information interchange the date and time notation (Dataelementsandinterchange
formats-Informationinterchange-Representationofdatesandtimes)
ISO 11138 (all parts) Sterilization of health care products - Biological indicators system (Sterilizationofhealthcareprod-
ucts-Biologicalindicatorssystems)
ISO 11607 Packaging for terminally sterilized medical devices (Packagingforterminalysterilizedmedicaldevices)
ISO 18472 Sterilization of health care products biological and chemical indicators of test equipment (Sterilizationofhealthcareprod-
ucts-Biologicalandchemicalindicators-Testequipment)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Yin open bleed
Migrate beyond the boundary indicator indicator printed.
3.2
The key variable criticalvariable
Parameter sterilization process required (and requires monitoring).
3.3
Endpoint endpoint
Observable change point defined by the manufacturer of the indicator after exposure to a predetermined calibration value appears.
3.4
Progressive reaction graduatedresponse
Exposure to visual change gradual after one or more allowed the assessment to the level of process variables appear.
3.5
Indicator indicator
Indicator to its final application to the substrate composition form (see Appendix E).
Note. The specific composition of the test load indicator system is also defined as the indicator.
3.6
Indicator/indicator reagent indicatoragent/indicatorreagent
Combination of active substance or active substances (see Appendix E).
3.7
Indicator system indicatorsystem
Combination indicator and its substrate, is then used in combination with a specific load test.
3.8
Off off-set
Indicator transferred to the surface of the material and instructions close contact.
3.9
Parameter parameter
Predetermined process variable value.
3.10
Penetration penetration
Indicator reached through the substrate surface where the indicator of negative migration.
3.11
Saturated steam saturatedsteam
In the water vapor condensation and vaporization equilibrium between states.
3.12
Calibration values statedvalue; SV
When the indicator changes by the end of indicators defined by the manufacturer, or the value of the process value range of key variables.
3.13
Substrate substrate
Suitable indicator carrier or support material (see Appendix E).
3.14
Variable variable
Conditions of the sterilization process, the change can affect the germicidal efficacy.
3.15
Visual change visiblechange
Defined by the manufacturer, the indicator after exposure to one or more process variables critical to the naked eye visible changes.
NOTE. The visual change is used to describe a class of process indicator reaction.
Category 4
4.1 Overview
In the following part of the GB 18282, indicators are classified by their intended use. Chemical indicators described in this section
Is divided into six categories, chemical indicators of each type of sterilization process according to their use for further division, saying only that the classification structure
Characteristics and models used by each manufacturer-defined indicators intended use. This classification does not grade sense.
4.2 categories. process indicator
Process indicator is intended for a single unit (such as sterilization packages, containers), used to indicate that the sterilization unit has been directly exposed to the sterilization process, and
Differentiate between the treated and untreated sterilization unit. They deal with sterilization key process variables with one or more reactive (see Table 1 to Table 6).
4.3 II. indicators for a particular test
2 indicator intended for specific test procedures related sterilizer/sterilization specified in the standard.
Note. The specific test indicators (2 indicator) requirements are given in other parts of GB 18282.
4.4 three categories. single-variable indicator
Univariate indicator key variables to deal with one sterilized react (see 5.2), and is used to indicate that the sterilization process in which it is exposed
It from the variable response reaches the calibration value requirements (see 5.7 and 5.8).
4.5 four categories. multi-variable indicator
Multivariate response sterilization indicator key variables in two or more reactive (see 5.2), and for weeks it showed during the sterilization exposure
Those variable period it reacts reaches the calibration value requirements (see 5.7 and 5.8).
4.6 five categories. integrated indicator
Integration sterilization indicators address all key variables react, resulting calibration values equal to or exceeds the ISO 11138 series of standards to
A biological indicator of performance requirements (see Chapter 11 ~ Chapter 13).
4.7 six categories. analog indicator
Analog indicator is to verify the sterilization cycle indicator, which address all key variables specific sterilization sterilization cycle reacts to its rated value
The key variables resulting from specific sterilization process.
5 General requirements
5.1 requirements of this chapter apply to all indicators, unless amended or excluded in the outer part of GB 18282 or subsequent chapter.
5.2 for different sterilization process, the following parameters are defined as key variables.
--- Steam. time, temperature, and water (saturated steam through transmission);
--- Dry heat. time and temperature;
--- Ethylene oxide. time, temperature, relative humidity and ethylene oxide (EO) concentration;
--- Radiation. total absorbed dose;
--- Steam - Formaldehyde. time, temperature, water (saturated vapor transmission through) and formaldehyde concentration;
--- Vaporized hydrogen peroxide. time, temperature, concentration of hydrogen peroxide.
5.3 The manufacturer shall establish and maintain a formal expressly provided quality system to cover all the operations specified in this part.
Note. GB/T 19001 and YY/T 0287 describes a quality system design, manufacturing and testing requirements.
5.4 Each indicator should be clearly labeled suitable for the intended use of the type of procedure (see 5.6 and 5.7), including the category of the indicat...