GB/T 18279.2-2015 Sterilization of health care products-Part 2 : Guidance on the application of GB 18279.1
1 Scope
This part of GB 18279 provides guidance for the requirements in GB 18279.1-2015. It does not repeat the requirements and is not intended to be used in isolation.
The exclusions in GB 18279.1 apply also to this part.
For ease of reference, the clause numbering in this part corresponds to that in GB 18279.1-2015. Further guidance for the requirements given in GB 18279.1 is also included in Annex C of GB 18279.1-2015 and should be used in conjunction with this part.
This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in GB 18279.1-2015. This part is not intended for people lacking a basic knowledge of the principles of EO sterilization.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 18279.1-2015 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1 : 2007, IDT)
GB 18281.2-2015 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2 : 2006, IDT)
ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1 : General requirements
ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1 : Determination of a population of microorganisms on products
ISO 13485 : 2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 17664 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions in this document apply.
3.1
dunnage
material used to mimic all or part of a sterilization load
3.2
health care facility
set of physical infrastructure elements intended to support the delivery of specific health-related services
3.3
processing group
collection of products or product families that can be sterilized in the same EO sterilization process
Note: All products within the group have been determined to present an equal or lesser challenge to the sterilization process than the challenge device for that group.
3.4
EO product family
collection of products that are determined to be similar or equivalent for validation purposes
3.5
re-usable medical device
medical device designated or intended by the manufacturer as suitable for reprocessing and re-use
Note: This is not a medical device for single use only.
3.6
single use medical device
medical device that is designated or intended by the manufacturer for one-time use only
3.7
sterilization specialist
person with knowledge of the sterilization technology being utilized and its effects upon materials and microorganisms
Note: This level of knowledge has been obtained by both practical and theoretical means and the person does not require guidance on the basic principles of the technology involved
4 Quality management systems
4.1 Documentation
4.1.1 No guidance offered.
4.1.2 No guidance offered.
4.2 Management responsibility
4.2.1 Each organization should establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.
4.2.2 No guidance offered.
4.3 Product realization
4.3.1 Purchasing procedures in a health care facility should ensure that re-usable medical devices are supplied with validated instructions for cleaning, disinfection, sterilization and aeration as specified in ISO 17664.
4.3.2 For those facilities that do not fully comply with ISO 13485, such as health care facilities, procedures for identification of product and maintenance of traceability, should include the labelling of each item or package prior to sterilization with a lot control identifier that includes the following information:
a) the sterilizer ID or code;
b) the date of sterilization;
c) the cycle number (i.e. the cycle run of the day or sterilizer).
It is recommended that the identity of the person who assembled the pack also be included on the identifier, to allow for further investigation if a problem should arise.
Lot identification information enables personnel to retrieve items in the event of a recall and to trace problems to their source.
4.3.3 No guidance offered.
4.4 Measurement, analysis and improvement - Control of non-conforming product
No guidance offered.
5 Sterilizing agent characterization
5.1 Sterilizing agent
EO is a highly penetrative gas that will permeate most packaging materials and polymeric materials. Widely recognized compositions include 100 % EO and blends with carbon dioxide or nitrogen. The storage conditions for EO should be in accordance with the EO manufacturer’s recommendations and all applicable regulations.
5.2 Microbicidal effectiveness
No guidance offered.
5.3 Materials effects
No guidance offered.
5.4 Environmental considerations
5.4.1 EO is toxic, flammable and explosive; therefore, extreme caution should be used during its storage, handling and use.
5.4.2 Effluent gas should be discharged through an EO-gas treatment system, such as a catalytic oxidiser, wet acid scrubber or thermal oxidiser.
When choosing a diluent, its ozone depleting potential should be taken into consideration.
6 Process and equipment characterization
Foreword I
Introduction III
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (Informative) Guidance on GB 18279.1-2015 Annex A Determination of process lethality - Biological indicator/bioburden approach
Annex B (Informative) Guidance on GB 18279.1-2015 Annex B Conservative determination of lethal rate of the sterilization process - Overkill approach
Bibliography
GB/T 18279.2-2015 Sterilization of health care products-Part 2 : Guidance on the application of GB 18279.1
1 Scope
This part of GB 18279 provides guidance for the requirements in GB 18279.1-2015. It does not repeat the requirements and is not intended to be used in isolation.
The exclusions in GB 18279.1 apply also to this part.
For ease of reference, the clause numbering in this part corresponds to that in GB 18279.1-2015. Further guidance for the requirements given in GB 18279.1 is also included in Annex C of GB 18279.1-2015 and should be used in conjunction with this part.
This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in GB 18279.1-2015. This part is not intended for people lacking a basic knowledge of the principles of EO sterilization.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 18279.1-2015 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1 : 2007, IDT)
GB 18281.2-2015 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2 : 2006, IDT)
ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1 : General requirements
ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1 : Determination of a population of microorganisms on products
ISO 13485 : 2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 17664 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions in this document apply.
3.1
dunnage
material used to mimic all or part of a sterilization load
3.2
health care facility
set of physical infrastructure elements intended to support the delivery of specific health-related services
3.3
processing group
collection of products or product families that can be sterilized in the same EO sterilization process
Note: All products within the group have been determined to present an equal or lesser challenge to the sterilization process than the challenge device for that group.
3.4
EO product family
collection of products that are determined to be similar or equivalent for validation purposes
3.5
re-usable medical device
medical device designated or intended by the manufacturer as suitable for reprocessing and re-use
Note: This is not a medical device for single use only.
3.6
single use medical device
medical device that is designated or intended by the manufacturer for one-time use only
3.7
sterilization specialist
person with knowledge of the sterilization technology being utilized and its effects upon materials and microorganisms
Note: This level of knowledge has been obtained by both practical and theoretical means and the person does not require guidance on the basic principles of the technology involved
4 Quality management systems
4.1 Documentation
4.1.1 No guidance offered.
4.1.2 No guidance offered.
4.2 Management responsibility
4.2.1 Each organization should establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.
4.2.2 No guidance offered.
4.3 Product realization
4.3.1 Purchasing procedures in a health care facility should ensure that re-usable medical devices are supplied with validated instructions for cleaning, disinfection, sterilization and aeration as specified in ISO 17664.
4.3.2 For those facilities that do not fully comply with ISO 13485, such as health care facilities, procedures for identification of product and maintenance of traceability, should include the labelling of each item or package prior to sterilization with a lot control identifier that includes the following information:
a) the sterilizer ID or code;
b) the date of sterilization;
c) the cycle number (i.e. the cycle run of the day or sterilizer).
It is recommended that the identity of the person who assembled the pack also be included on the identifier, to allow for further investigation if a problem should arise.
Lot identification information enables personnel to retrieve items in the event of a recall and to trace problems to their source.
4.3.3 No guidance offered.
4.4 Measurement, analysis and improvement - Control of non-conforming product
No guidance offered.
5 Sterilizing agent characterization
5.1 Sterilizing agent
EO is a highly penetrative gas that will permeate most packaging materials and polymeric materials. Widely recognized compositions include 100 % EO and blends with carbon dioxide or nitrogen. The storage conditions for EO should be in accordance with the EO manufacturer’s recommendations and all applicable regulations.
5.2 Microbicidal effectiveness
No guidance offered.
5.3 Materials effects
No guidance offered.
5.4 Environmental considerations
5.4.1 EO is toxic, flammable and explosive; therefore, extreme caution should be used during its storage, handling and use.
5.4.2 Effluent gas should be discharged through an EO-gas treatment system, such as a catalytic oxidiser, wet acid scrubber or thermal oxidiser.
When choosing a diluent, its ozone depleting potential should be taken into consideration.
6 Process and equipment characterization
Contents of GB/T 18279.2-2015
Foreword I
Introduction III
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (Informative) Guidance on GB 18279.1-2015 Annex A Determination of process lethality - Biological indicator/bioburden approach
Annex B (Informative) Guidance on GB 18279.1-2015 Annex B Conservative determination of lethal rate of the sterilization process - Overkill approach
Bibliography
