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GB 18281.1-2015 English PDF (GB18281.1-2015)

GB 18281.1-2015 English PDF (GB18281.1-2015)

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GB 18281.1-2015: Sterilization of health care products -- Biological indicators -- Part 1: General requirements

GB 18281.1-2015
Sterilization of health care products - Biological indicators - Part 1. General ICS 11.080.01
C47
National Standards of People's Republic of China
Replacing GB 18281.1-2000
Sterilization of health care products - Biological indicators
Part 1. General
(ISO 11138.2006, 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
Foreword
All technical content in this Part of GB 18281 is mandatory.
GB 18281 "Sterilization of health care products - Biological indicators" is divided into five parts. --- Part 1. General;
--- Part 2. Biological indicators for ethylene oxide sterilization thereof; --- Part 3. Biological indicators for moist heat sterilization;
--- Part 4. Biological indicators for dry heat sterilization thereof;
--- Part 5. low temperature steam formaldehyde sterilization biological indicators. This section is part of the 1 GB 18281.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This Part replaces GB 18281.1-2000 "Sterilization of health care products - Biological indicators - Part 1. General", compared with GB 18281.1-2000, the main technical changes are as follows. --- Adds specific information, self-contained biological indicator of;
--- Increase the comprehensive labeling requirements of the chart;
--- Increased use of bio-indicators on other aspects of the specific minimum biomass and/or resistance standard range of requirements, which range on the product label are described in detail; --- Defined in Appendix D can be calculated D values HSKP, LHSKP or SMCP methods. This section uses the translation method identical with ISO 11138-1.2006 "Sterilization of health care products - Biological 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 18278.1-2015 heat sterilization of health care products - Part 1. Medical device sterilization process development, validation and routine control requirements (ISO 17665-1.2006, IDT); --- GB 18279.1-2015 Sterilization of health care products of ethylene oxide - Part 1. Development of medical device sterilization process, validation and routine control requirements (ISO 11135-1.2007, IDT); --- GB/T 18279.2-2015 Sterilization of health care products of ethylene oxide - Part 2. GB 18279.1 Application Guide (ISO 11135-2.2008, IDT); --- 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); --- GB 18280.2-2015 Sterilization of health care products - Radiation - Part 2. Establish sterilization dose (ISO 11137-2.2006, IDT); --- GB/T 18280.3-2015 Radiation Sterilization of health care products - Part 3. Dose measurement guidelines (ISO 11137-3.2006, IDT); --- GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1. materials, sterile barrier systems and packaging systems requirements (ISO 11607-1.2006, IDT); --- GB/T 19633.2-2015 final packaging sterilized medical devices - Part 2. forming, sealing and assembly requires confirmation process (ISO 11607-2.2006, IDT); --- Sterilization Microbiological methods - Part 1 GB/T 19973.1-2015 medical devices. Determination of the total number of microorganisms on the product (ISO 11737-1.2006, IDT); --- GB/T 24628-2009 Sterilization of health care products biological and chemical indicators of test equipment (ISO 18472.2006, IDT); --- YY/T 0287-2003 medical device quality management system for regulatory requirements (ISO 13485.2003, IDT); Symbols - Part 1 --- YY/T 0466.1-2009 medical equipment used with medical device labels, labeling and information. General requirements (ISO 15223.2008, IDT). This part made the following editorial changes.
--- According to GB/T 1.1 requirements of a number of editorial changes; --- Deleted international standards foreword.
Please note that some of the content of this document may involve patents. Issuer of this 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. Shandong Xinhua Medical Instrument Co., 3M China Ltd, the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center.
The main drafters of this section. Wang Jiuru, Huang Xiulian, Huangjing Xiong, Zhao Jian deposit. This part of the standard replaces the previous editions are.
--- GB 18281.1-2000.
introduction
This section provides a biological indicator for monitoring sterilization cycle (including carrier contamination and bacterial suspension) in the production, labeling, and detection methods General performance requirements. Other parts of GB 18281 specifies the specific requirements of different biological indicator for the sterilization process. Appendix F provides detailed illustrations and part of the biological indicator, which contains GB 18281 of the two types of biological indicators, which The carrier may not indicate contamination of packaging to be sterile primary packaging material penetrable exposure to sterilizing factor. Resistance characteristics depend on the type of test organisms, quantity, preparation methods and the effect of primary packaging. About the choice of biological indicators, Use reference guide and the results of ISO 14161.
For any (including other parts of the described GB 18281) sterilization process, the resistance also depends on the biological indicator test When the microbial environment. In theory, this could lead to a lot of uncertainty in the process of preparing the biological indicator. In addition, the sterilization process May appear in a variety of situations, it is necessary to ensure that products in a variety of conditions can be fully exposed. Thus, when exposed to a variety of specific sterilization process When the conditions, norms resistance performance biological indicator for the production of D values and the associated z values. These values are in GB 18281 Other The provisions in both sections.
Professional manufacturers, users and management authorities are involved in the drafting of section GB 18281 Part 1 ~ 5, which represents the Today the level of development of science and technology.
Biological indicators in other parts of GB 18281's not covered by specific sterilization process should follow GB 18281 for General Requirements, including resistance performance testing. Such indicators can not be accurately defined, may be used for new sterilization process can also be used alone negative microorganisms Upload to represent. If these biological indicators containing WHO risk assessment team other than a group of microorganisms, should meet the appropriate security Tibetan method and level of security.
GB 18281 specifies the requirements and control to confirm the sterilization process. Sterilization of health care products - Biological indicators
Part 1. General
1 Scope
1.1 Application
1.1.1 GB 18281 of the provisions of this part of the biological indicators intended to be used to identify and monitor the sterilization cycles (including carrier contamination, the test bacteria suspension Liquid) and other components in the production, labeling, testing methods and general performance requirements. Basic requirements 1.1.2 This section applies to all other parts of GB 18281. For special process for sterilization of biological indicator Requirements in other parts of GB 18281 has prescribed. This section does not apply to the special requirements of biological indicators. 1.2 NA
This section does not apply to rely on physically removing microbial detection system, such as filtration or the use of cleaning and disinfection or steam circulation Steam and other physical and/or mechanical methods to remove microbial process. However, this section should contain content appropriate microbiological testing system. 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)
Part 1 ISO 11135-1 Sterilization of health care products of ethylene oxide. the development of medical device sterilization process, validation and routine Control requirements (Sterilizationofhealthcareproducts-Ethyleneoxide-Part 1. Requirementsfordevelop- ment, validationandroutinecontrolofasterilizationprocessformedicaldevices) ISO 11135-2 Sterilization of health care products of ethylene oxide - Part 2. ISO 11135-1 Application Guide (Sterilizationof healthcareproducts-Ethyleneoxide-Part 2. GuidanceontheapplicationofISO 11135-1) ISO 11137-1 Radiation Sterilization of health care products - Part 1. Development of medical equipment sterilization process, validation and routine control Requirements (Sterilizationofhealthcareproducts-Radiation-Part 1. Requirementsfordevelopment, validationandroutinecontrolofasterilizationprocessformedicaldevices)
ISO 11137-2 Sterilization of health care products - Radiation - Part 2. Establish sterilization dose (Sterilizationofhealthcare products-Radiation-Part 2. Establishingthesterilizationdose)
ISO 11137-3 Radiation Sterilization of health care products - Part 3. Dose Measurement Guide (Sterilizationofhealthcare products-Radiation-Part 3. Guidanceondosimetricaspects)
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1. materials, sterile barrier systems and packaging systems requirements (Packa- gingforterminalysterilizedmedicaldevices-Part 1. Requirementsformaterials, sterilebarriersys- temsandpackagingsystems)
ISO 11607-2 final packaging sterilized medical devices - Part 2. shaping, confirmation (Packagingfor sealing and assembly processes terminalysterilized medicaldevices-Part 2. Validationrequirementsforforming, sealingand assemblyprocesses)
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)
ISO 13485 medical device quality management system for regulatory requirements (Medicaldevices-Qualitymanagement systems-Requirementsforregulatorypurposes)
Symbol (Medicaldevices-Symbolsto ISO 15223 medical devices for medical device labels, labeling and information provided beusedwithmedicaldevicelabels, labelingandinformationtobesupplied)
ISO 17665-1 Sterilization of health care products heat - Part 1. Development of medical equipment sterilization process, validation and routine control Requirements (Sterilizationofhealthcareproducts-Moistheat-Part 1. Requirementsforthedevelopment, validationandroutinecontrolofasterilizationprocessformedicaldevices)
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
Biological indicators biologicalindicator
Provisions sterilization process has a specific resistance, the test system containing viable microorganisms. [ISO /T S11139.2006, the definition 2.3]
3.2
Carrier carrier
It can be coated test microorganism support materials.
3.3
Colony forming units colonyformingunit
CFU
By a single or multiple cell growth visible to the naked eye constitute viable microbial communities. 3.4
Culture Collection number culturecolectionnumber
A unique number provided by the test organisms scientifically recognized culture collection agency. 3.5
Culture conditions cultureconditions
Promote microbial recovery, a combination of growth and (or) growth media used in reproduction and vaccination methods. [ISO /T S11139.2006, definitions 2.10]
NOTE. inoculation inoculation methods include temperature, time of inoculation and vaccination of other specific conditions. 3.6
D value Dvalue
D10 value D10value
Under specified conditions, the time of 90% of the total inactivation of test organisms required or dose. [ISO /T S11139.2006, definitions 2.11]
3.7
FBIO value FBIOvalue
It reflects the resistance of biological indicator, which is based on the value of the number of D and microorganisms to reduce the amount of product calculated. 3.8
Inactivation inactivation
Microbial growth and (or) loss of reproductive capacity.
[ISO /T S11139.2006, definitions 2.21]
3.9
Inactivation curve inactivationcurve
Under the conditions set by the test microorganism inactivation and sterilization media exposure enhanced relationship graph. 3.10
Ranjun carrier inoculatedcarrier
The number of test organisms have been infected with the provisions of the carrier. Note. See Appendix F.
3.11
The total number of microorganisms calibration nominalpopulation
Manufacturing trademark given the number of viable microorganisms.
NOTE. lg generally a function of the expression (eg, 106).
3.12
Packaging systems packagesystem
Sterile barrier system and protective packaging portfolio.
[ISO /T S11139.2006, definitions 2.28]
3.13
Primary packaging primarypackage
Part of the packaging system for maintaining product integrity.
Note. The carrier contamination protection from damage and contamination, without obstructing the penetration factor sterilization system. 3.14
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]
3.15
Resistance meter resistometer
To measure physical sterilization process produces and/or related combinatorial chemistry parameters designed measurement equipment. 3.16
Secondary packaging secondarypackage
Containing biological indicator has been packaged for transport and storage of packaging systems. 3.17
The self-contained biological indicator self-containedbiologicalindicator Primary package containing the test required for the growth of microorganisms recovery media biological indicator. 3.18
Survival - kill zone survival-kilwindow
Under specified conditions during the sterilization process, the biological indicator survived the transition from micro-organisms (survival time) to kill all microorganisms (kill Off time) of exposure.
3.19
Bacterial suspension suspension
Liquid that contains live test organisms.
NOTE. packed in sealed ampoules bacterial suspension can be used as a biological indicator used bacterial suspension may be Ranjun carrier or biological indicator of Intermediate.
3.20
Viable amount viablecount
The actual number of colony forming units recyclable or other suitable units. Note. See Appendix A.
3.21
z value zvalue
So that a D value change value magnitude required temperature.
NOTE. See ISO 11138-3 and ISO 11138-4.
4 Production General requirements
4.1 Production Control
4.1.1 Quality System
The manufacturer shall establish in accordance with this section, the recording and continuous operation of a complete set of quality system (such as ISO 13485, GMPS or country Other requirements) to cover all operating requirements. In particular, the manufacturer should take effective measures at all stages of production to reduce biological Indicator produce adverse effects.
4.1.2 Traceability
Traceability content 4.1.2.1 manufactured components should be saved.
4.1.2.2 manufactured components should be included or incorporated in direct contact with the test bacteria suspension Ranjun carrier or primary packaging materials and all groups As ingredients.
4.1.3 final product requirements
Final product shall comply with the requirements of this section.
a) Production (Chapter 5);
b) label (4.3);
c) resistance characteristic (6.4);
d) storage and transport (4.4).
Note. The use of biological indicators refer to ISO 14161.
4.1.4 staff
Steps and methods specified in this section shall be trained and experienced laboratory personnel to implement (see 4.1.1). 4.2 test organisms
4.2.1 Strain
4.2.1.1 test organisms should be identified as a strain, the correct detection method from a recognized culture collection agencies, and through conduct confirm.
4.2.1.2 test microorganism strain should meet the following criteria.
a) test organisms priate ways to handle, does not require special preservation method does not require special operating conditions, no special Special transport and postal requirements (eg WHO risk assessment team, a set of requirements); b) transport and storage shelf life regulations, can effectively maintain their resistance strains. Note. In general, the use of biological indicator test organisms from bacteria spores. 4.2.1.3 In addition to bacterial spores, the test organisms may be proven to be a suitable sterilization process resistance of microorganisms. 4.2.2 The initial bacterial suspension inoculum
4.2.2.1 each batch of test organisms suspension initial inoculum should meet the following requirements. a) can be traced back to the standard strains of bacteria recognized depositary institution; b) verify the type and purity.
4.2.2.2 Microorganisms designated storage test method should be able to ensure that culture is not contaminated, and the cause of its inherent properties change Reducing adverse effects at a minimum.
4.2.2.3 The manufacturer shall record and verify detailed verification test test bacteria per plant. 4.2.3 Number of test microorganisms
4.2.3.1 The test microorganism suspension of viable count carried out in accordance with Appendix A of. 4.2.3.2 users need to test microorganism growth index, the number of test organisms should be effectively expressed in bacteria resulting accounting microscopy The percentage of the total.
4.3 Information supplied by the manufacturer (label)
4.3.1 each batch of bacterial suspension on the label carrier contamination and biological indicators should have the following description. --- Traceability of the production process unique number;
--- The name of the test organisms;
--- Suitable bacterial suspension, the carrier contamination and biological indicators of sterilization processes; --- In the manner specified in ISO 8601 marked expiration date, for example, ×××× ×× month ×× in May; --- Manufacturer's name, trademark, address or other method of identification; Use of internationally recognized symbols in the right place (see 4.1.3 and ISO 15223). 4.3.2 each batch of product packaging should include the information in Table 1 given. 4.3.3 Symbols used on the label may refer to the provisions of ISO 15223. Table 1 Information supplied by the manufacturer
Information requirements ba...

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