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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 me...