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GB 18280.2-2015 English PDF (GB18280.2-2015)

GB 18280.2-2015 English PDF (GB18280.2-2015)

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GB 18280.2-2015: Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose

GB 18280.2-2015
Sterilization of health care products - Radiation - Part 2. Establishing the sterilization dose ICS 11.080.01
National Standards of People's Republic of China
Partly replace GB 18280-2000
Radiation Sterilization of health care products
Part 2. Establish sterilization dose
Part 2. Establishingthesterilizationdose
(ISO 11137-2.2006, IDT)
Issued on. 2015-12-31
2017-07-01 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 acronyms, terminology and definitions
4 dose setting, the definition of dose and the sterilization dose audit confirmed that the product family and for 4 5 establish and verify the sterilization dose selection and testing of products in 6 The method established dose 8
7 Method 1. use of biological load information set dose 8
8 Method 2. derived from the incremental dose of positive test score information to determine the dose extrapolation factor method of setting 15 9 VDmax method --- 25kGy or 15kGy as a sterilization dose of 21 confirmed 10 sterilization dose audit 29
11 Example 35
References 50
All technical content in this Part of GB 18280 is mandatory.
GB 18280 "Radiation Sterilization of health care products" is divided into the following sections. --- GB 18280.1 Radiation Sterilization of health care products - Part 1. Development of medical equipment sterilization process, validation and routine control System requirements;
--- GB 18280.2 Sterilization of health care products - Radiation - Part 2. Establish sterilization dose; --- GB/T 18280.3 Radiation Sterilization of health care products - Part 3. dose measurement guide. This is Part 2 GB 18280's.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This portion instead of GB 18280-2000 "Sterilization of health care products Requirements for validation and routine control of radiation sterilization", and GB 18280-2000 compared, this section developed from GB 18280-2000 Appendix B, the main technical changes as follows. --- Increase the definition of the product family;
--- Refine the method to establish the dose, more detailed description of Tier 1 and Tier 2 applications; --- Increased VDmax method.
This section uses the translation method identical with ISO 11137-2.2006 "Sterilization of health care products - Radiation - Part 2. Create sterilization dose".
The correspondence between the consistency of the international normative documents referenced in our country with the following documents. --- GB/T 19973.1-2005 Sterilization of health care products - Microbiological methods - Part 1. The total number of microorganisms on the product assessment Meter (ISO 11737-1.1994, IDT);
--- GB /learning methods - Part 2 T 19973.2-2005 microbial sterilization of medical devices. sterility test confirmed the sterilization process (ISO 11737-2.1998, IDT).
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 is drafted. Beijing Radiation Application Research Center, Shenzhen Jinpeng source of radiation Technology Co., Ltd., the State Food and Drug Administration Administration of Guangzhou Medical Device Quality Supervision and Inspection Center. The main drafters of this section. Hu Jinhui, Bao spear, Xu Honglei, Lin Naijie, Chen Qiang, SHEN Ling. This part of the standard replaces the previous editions are.
--- GB 18280-2000.
GB 18280 This section describes two ways according to GB 18280.1-2015 8.2 given in any one establishment sterilization Dose approach. These methods are.
a) obtaining a method of setting product-specific dose;
b) for a pre-selected or 15kGy do 25kGy dose confirmed.
Foundation set dose method described in this section is mainly Talentire first proposed (Talentire, 1973 [17]; Talentire, DwyerandLey, 1971 [18]; TalentireandKhan, 1978 [19]). Thereafter, the dosage form of the draft standard setting Methodological basis through AAMI recommended γ radiation sterilization practices (AAMI1984,1991 [4], [6]) to develop (Davisetal after thinning., 1981 [8]; Davis, StrawdermanandWhitby, 1984 [9]).
Methods 1 and 2 and the relevant dose audit procedures use data derived from the natural state in the presence of microorganisms on products body. Based on microbial population inactivation probability model. Since the bioburden of different microbial species composition, probabilistic model for each set D10 value of individual species of microorganisms. In the model, when given with radiation dose, a product of the probability of a surviving microorganism is Irradiated products before initial number of microorganisms and D10 values determined. The method comprises less than after the sterilization dose of radiation products, products that do not Bacteria Test. Results of the tests used to predict the predetermined sterility assurance level of the dose required. In the embodiment set dose trials, Tier 1 and Tier 2 can also be used to confirm the 25kGy to achieve a sterility assurance level of 10-6. Confirmed 25kGy method, namely. VDmax method by KowalskiandTalentire (1999) [14] development. Thereafter, the basic principles Li made the assessment, including the application of computer presentations, and laid a good foundation (Kowalski for this method, Aoshuangand Talentire, 2000 [13]), the field test demonstrated VDmax method for a variety of methods for producing the assembly out of the sterilization and products are all Efficiency (Kowalskietal., 2002 [16]).
Use VDmax method confirmed 25kGy sterilization dose as a standard procedure has been published in the AAMI technical report "Health Care Radiation sterilized product was confirmed as the sterilization dose VDmax 25kGy method "(AAMITIR27.2001) [5], this document sets The main principle VDmax methods. VDmax based on dose setting Method 1, it has a high security. VDmax dose provided similar Setting Method 1, including After the sterilization dose lower than the dose of radiation products, products for sterility test. The results of the test for confirming 25kGy To achieve a sterility assurance level of 10-6.
To represent VDmax proven method of pre-dose, the dose values will kGy units written in VDmax top right corner. Confirmed 25kGy, He expressed as VDmax25.
Similarly, it was confirmed 15kGy expressed as VDmax15. Use VDmax15 test program is limited to the average bioburden ≤1.5 products, other And VDmax25 same. Test results can be used to confirm 15kGy so that products meet a sterility assurance level of 10-6. This section also describes the basis for Chapter 12 GB 18280.1-2015 embodiment dose audit approach. After the establishment of the sterilization dose, Sterilization dose audit is a routine conventional procedures to ensure continuous sterilization dose needed to achieve a sterility assurance level. Radiation Sterilization of health care products
Part 2. Establish sterilization dose
1 Scope
GB 18280 of the provisions of this part of the setting method and confirmed to meet the special requirements of sterile minimum dose of 25kGy or 15kGy as to achieve the 10-6 sterility assurance level (SAL) of the sterilization dose approach. This section also provides a dose audit approach to As evidenced by sustained and effective sterilization dose.
This section defines for dose establishment and dose auditing product family. 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. GB 18280.1-2015 Radiation Sterilization of health care products - Part 1. Development of medical equipment sterilization process, validation and routine Control requirements (ISO 11137-1.2006, IDT)
Sterilization Microbiological methods - Part 1 ISO 11737-1 medical devices. the total number of microorganisms on the product estimate (Sterilizationofmedicaldevices-Microbiologicalmethods-Part 1. Determinationofapopulationof microorganismsonproducts)
Learn sterilization methods - Part 2 microorganisms ISO 11737-2 medical devices. sterility test confirmed the sterilization process (Sterilizationofmedicaldevices-Microbiologicalmethods-Part 2. Testsofsterilityperformedinthe validationofasterilizationprocess)
3 acronyms, terms and definitions
GB 18280.1-2015 defined and the following abbreviations, terms and definitions apply to this document. 3.1 Acronyms
Adjustment value ffp down to FFP dose.
CD *
In the process of verification dose experiment 2, the number of positive tests obtained from 100 sterile product unit. 3.1.3
d *
Extracted from a given batch of products production unit, so the incremental dose experiment, obtained from the test dose. 3.1.4
D *
To test products meet the initial estimate of the dose 10-2SAL.
NOTE. This value is generally the value of a given product 3d * values. 3.1.5
D **
Test test product is estimated to reach 10-2SAL final dose, the dose used to calculate the sterilization dose. 3.1.6
DD *
The method of verification dose experiment 2 the dose.
DD * After radiation, the estimated value of D10 microorganisms present in the product. 3.1.8
D value Dvalue
D10 value D10value
Under specified conditions, killing 90% of the dose or amount of time required for the microorganism. [ISO /T S11139.2006]
Note. In this section, D10 value is only used dose, not for time.
The first positive fraction dose firstfractionpositivedose
Series of incremental doses of radiation extracted from a given product batch production units, after 20 radiation has at least one unit of product Sterility test negative for the lowest dose.
The first positive fraction dose FirstFractionPositivedose
So 20 sterility testing positive for 19 doses calculated by subtracting from the value of A 3ffp obtained. 3.1.11
No positive first dose FirstNoPositivedose
Estimated dose 10-2SAL used to compute DS.
Verify that the maximum dose given bioburden, can be achieved using 15kGy 10-6SAL. 3.1.13
For a given maximum dose verification bioburden, can be achieved using 25kGy 10-6SAL. 3.2 Terms and Definitions
Batch batch
We expect consistent in character and quality, and produced in a defined manufacturing cycle a predetermined amount of product. [ISO /T S11139.2006]
Bioburden bioburden
A product/or and/or wherein the total number of viable microorganisms and sterile barrier system. [ISO /T S11139.2006]
False positive falsepositive
Turbidity test results are interpreted as a product or share microbial growth, and microbial growth is due to microbial contamination of alien Or cloudiness is caused due to the result of the product or share test medium and influence each other. 3.2.4
Positive fraction fractionpositive
In the number of positive tests for sterility molecules to the test as the denominator of the quotient. 3.2.5
Incremental doses incrementaldose
A series of products for a number of radiation dose or a share in the dose setting methods for obtaining or confirm the sterilization dose. 3.2.6
Sterile negative test negativetestofsterility
In sterility testing, product or share the product after the culture can not check the growth of microorganisms. 3.2.7
Packaging systems packagingsystem
Sterile barrier system and protective packaging combination.
[ISO /T S11139.2006]
Sterile positive test positivetestofsterility
In sterility testing, product or share after training to check the growth of microorganisms. 3.2.9
Sample share sampleitemportion; SIP
Of the share covered by the detection unit of health care products.
Sterile barrier systems sterilebarriersystem
Prevent microbial products into the smallest package for the product when used in a sterile condition and use. 3.2.11
Sterility assurance level sterilityassurancelevel; SAL
The probability of a viable microorganism present on product after sterilization unit. NOTE. SAL represents a value, generally 10-6 or 10-3, 10-6 compared with 10-3 although small, but larger than the guarantee provided by 10-3. 3.2.12
Sterilization dose audit sterilizationdoseaudit
It confirmed the suitability of the established activities sterilization dose. 3.2.13
Verify dose verificationdose
The establishment of the sterilization dose, sterilization dose to achieve the predetermined SAL≥10-2. 4 dose setting, confirm and define the dose sterilization dose audit product family and holding 4.1 General
Establish the sterilization dose and the sterilization dose audit is the process of implementation of the definition (see Chapter 8 GB 18280.1-2015) and maintaining the validity of the process Part of the activities (see GB 18280.1-2015 Chapter 12). For these activities, the products into product family, product family is divided main root According to the product or product in the memory of the number and types of microorganisms (bioburden). Microbiological reflects its resistance to radiation. Production division Does not consider the product density and product packaging systems in loading mode product family, because these factors do not affect the biological load. Use product family in establishing the sterilization dose and the sterilization dose audit, in the production process, unexpected changes in the radiation found to affect the validity of The ability to reduce the risk is very important. Moreover, the use of a single product represents the product family may not find the other members of the product family changes occur. Should assess the risk of changes in other product family members found reduced capacity, and before the beginning of the sterilization process should be developed and implemented to maintain production Product family plan.
Note. See YY/T 0316 and risk management guidelines.
4.2 product family is divided
4.2.1 division of product family standards should be documented. According to these standards and to consider similar review the product of potential product family members. Should take into account changes in the product could affect the bioburden, including but not limited to the following factors. Nature and source of a) raw materials, sources of raw materials if more than one place, but also its impact; b) constitute a product;
c) product design and size;
d) the production process;
e) production equipment;
f) the production environment;
g) Production address.
Results record review and consideration (see GB 18280.1-2015 in 4.1.2). 4.2.2 only have to prove that products related changes (see 4.2.1) and similar controlled, this product can be attributed to a product family. 4.2.3 only when the volume and variety of product bioburden similar to attributed to a product family. 4.2.4 product family is included in more than one place of production and should prove that this classification is justified and recorded (see GB 18280.1-2015 in 4.1.2), it should consider its role in biological load. a) Geographic and (or) climatic differences between different locations; b) any differences in the production process or environmental control;
c) sources of raw materials and auxiliary materials (for example. water). 4.3 verification dose experiments and sterilization dose audits for product family represent the product design 4.3.1 product family representative products on product volume and type of microbial bioburden is to select the product family represents the product basis. product family may be composed of representatives of the following products. a) the main product (see 4.3.2); or
b) equivalent product (see 4.3.3); or
c) simulation products (see 4.3.4). determined in accordance with three possible products on behalf of any one as a representative product review should be formal, documented of. In the review, should consider the following questions.
a) the number of bioburden microorganisms;
b) the presence of microorganisms environment;
c) size of the product;
The number of components d) products;
Complexity e) of product;
f) the degree of automation in the production process;
g) production environment.
4.3.2 Main Products
If the assessment indicates that a biological challenge for product family product family is greater than the other products, this product can be identified based production Goods. In some cases, there are several products that can be identified based products, in this case, according to 4.3.3, any of these products are a It can be set as the main product, representing the product family.
4.3.3 Equivalent products
If the assessment (see indicate a product family of products require the same sterilization dose, the product family of products can be considered, etc. The same product. Chosen to represent the equivalent product family that is representative of the product may be. a) random; it can be b) according to a schedule Select a product family Different products. Select equivalent product should be considered representative of the product family and product production feasibility. 4.3.4 Analog Products
In the sterilization process, when the analog products than the product or family of products are equivalent to a larger biological challenges, this product can be used as the analog Representative product family. Packing and packaging materials used for analog products should be the same as the actual product. Note. The analog products are not used clinically only for establishing and maintaining the sterilization dose. Analog products can be.
a) the actual product of similar materials and dimensions, through a similar process, for example. after the complete production process of an implant Materials; or
b) product family combination product components, in use, is not a typical example. containing a complex filter, clip, set of soft piston Tube, these components of the product family in other products, too.
4.4 product family holding
4.4.1 Periodic review
This review shall be carried out within a predetermined frequency to determine the product family and represents the product family of products remain in force. Review the product and/or process May affect product family of products, the assessment should be assigned the responsibility to capable people. Such a review at least once a year. Review of Results Fruit should be recorded in accordance with GB 18280.1-2015 4.1.2.
4.4.2 modify products and/or production process
Modifications to the product, such as. raw materials (nature and sources), product design or components (including size) and/or modification of the production process (for example. Equipment, the environment and workplace) should be formal, documented change control system review. Such modifications may change according to the product family divided According to representatives of the ethnic products or select a product basis. Major changes require redrawing new product family and provide for different representative products. 4.4.3 Records
Shall keep a reco...

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