Sterilization of health care products―Ethylene oxide―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
1 Scope
This part of GB 18279 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.
Note: Although the scope of this part is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.
Sterilization processes validated and controlled in accordance with the requirements of this part are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
Note 2: See for example YY/T 0771.1, YY/T 0771.2 and YY/T 0771.3.
This part does not detail a specified requirement for designating a medical device as sterile.
Note 3: Attention is drawn to national or regional requirements for designating medical devices as "sterile". See for example EN 556-1 or ANSI/AAMI ST67.
This part does not specify a quality management system for the control of all stages of production of medical devices.
Note 4: The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this part to have a complete quality management system during manufacture or reprocessing, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see in particular Clause 4). National and/or regional regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party.
This part does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
Note 5: For further information on safety, see examples in the Bibliography. National or regional regulations may also exist.
Note 6: Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling ethylene oxide and for premises in which it is used.
This part does not cover sterilization by injecting ethylene oxide or mixtures containing ethylene oxide directly into individual product packages, or continuous sterilization processes.
This part does not cover analytical methods for determining levels of residual ethylene oxide and/or its reaction products.
Note 7: For further information see ISO 10993-7.
Note 8: Attention is drawn to the possible existence of regulations specifying limits for the level of ethylene oxide residues present on or in medical devices and products.
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 18281.2-2015 Sterilization of health care products - Biological indicator - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2: 2006, IDT)
GB/T 19974-2005 Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices(ISO 14937:2000, IDT)
ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11140-1 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 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14161 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
aeration
part of the sterilization process during which ethylene oxide and/or its reaction products desorb from the medical device until predetermined levels are reached
Note: This may be performed within the sterilizer and/or in a separate chamber or room.
3.2
aeration area
either a chamber or a room in which aeration occurs
3.3
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[GB/T 19971-2015, definition 2.2]
3.4
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
[GB/T 19971-2015, definition 2.3]
3.5
calibration
set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards
[VIM:1993, definition 6.11]
3.6
chemical indicator
test system that reveals change in one or more predefined process variable(s) based on a chemical or physical change resulting from exposure to a process
[GB/T 19971-2015, definition 2.6]
3.7
conditioning
treatment of product within the sterilization cycle, but prior to ethylene oxide admission, to attain a predetermined temperature and relative humidity
Note: This part of the sterilization cycle can be carried out either at atmospheric pressure or under vacuum.
See 3.25, preconditioning.
Foreword I
Introduction IV
1 Scope
2 Normative References
3 Terms and definitions
4 Quality Management System
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 (Normative) Determination of lethal rate of the sterilization process - Biological indicator/bioburden approach
Annex B (Normative) Conservative determination of lethal rate of the sterilization process - Overkill approach
Annex C (Informative) General guidance
Bibliography
