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GB 18279-2023. Development, validation and routine control requirements for ethylene oxide medical device sterilization process for sterilization of healthcare products
ICS 11.080.01
CCSC47
National Standards of People's Republic of China
Replace GB 18279.1-2015, GB/T 18279.2-2015
Healthcare Products Sterilization Ethylene Oxide Medical Devices
Requirements for the development, validation and routine control of sterilization processes
(ISO 11135.2014,MOD)
Published on 2023-09-08
Implemented on 2026-10-01
State Administration for Market Regulation
Released by the National Standardization Administration Committee
Table of contents
PrefaceⅠ
Introduction III
1 range 1
2 Normative reference documents 1
3 Terms and Definitions 2
4 Quality Management System 8
5 Characteristics of sterilization factors 8
6 Process and equipment characteristics 9
7 Product Definition10
8 Process Definition 11
9 Confirm 12
10 Routine monitoring and control15
11 Sterilization release of products16
12 Maintain sterilization process effectiveness16
Appendix A (Normative) Determination of Killing Rate of Sterilization Process---Biological Indicators/Bioburden Method 18
Appendix B (Normative) Method for conservatively determining the killing rate of the sterilization process---Overkill method 19
Appendix C (informative) Number of temperature sensors, humidity sensors and biological indicators 20
Appendix D (informative) Guidance on the application of normative requirements23
Appendix E (normative) Single batch release 49
Reference 51
Preface
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document replaces GB 18279.1-2015 "Ethylene oxide for sterilization of medical and health care products - Part 1.Medical device sterilization process
Requirements for Development, Qualification and Routine Control" and GB/T 18279.2-2015 "Sterilization of Healthcare Products with Ethylene Oxide Part 2.
"GB 18279.1 Application Guide", in addition to structural adjustments and editorial changes, the main technical changes are as follows.
---Added instructions for the application of this document by health care institutions (see 1.1);
---Added some terms (see 3.10, 3.38, 3.43, 3.57);
---Deleted some terms (see 3.19 of GB 18279.1-2015, 3.1 of GB/T 18279.2-2015);
---Changed the requirements for quality management system (see 4.1, 4.2, 4.3, 4.1, 4.2, 4.3 of GB 18279.1-2015);
---Changed the requirements for sterilization factors (see 5.1, 5.2, 5.5, 5.1, 5.4 of GB 18279.1-2015);
---Added an overview of process and equipment characteristics (see 6.1);
---Changed the requirements for process characteristics (see 6.2, 6.1 of GB 18279.1-2015);
---Added the purpose and content of product definition (see 7.1.1, 7.1.5);
---Deleted the requirement for the most difficult to sterilize position (see 7.1.3 of GB 18279.1-2015);
---Added the purpose of process definition (see 8.1);
---Added general rules for confirmation (see 9.1);
--- Added requirements for installation qualification (see 9.2.1.3, 9.2.2.3, 9.2.2.4, 9.2.2.6);
--- Added requirements for performance qualification (see 9.4.1.1, 9.4.1.5, 9.4.1.6);
---Changed the requirements for performance qualification (see 9.4.1.8, 9.3 of GB 18279.1-2015);
--- Added requirements for microbial performance identification (see 9.4.2.5, 9.4.2.6, 9.4.3.2);
---Added parameters that should be specified in the confirmation report (see 9.5.4);
---Added the purpose and requirements of routine monitoring (see 10.1, 10.2, 10.3);
---Changed the requirements for product release (see 11.2, 11.3, 11.4, Chapter 11 of GB 18279.1-2015);
---Changed the requirements for requalification (see 12.3.1, 12.3.3, 12.3 of GB 18279.1-2015);
--- Added requirements for change assessment (see 12.4.2, 12.4.6);
---Added the content of equivalent evaluation (see 12.5);
---Deleted the description of the procedures and calculation methods of the biological indicator/bioburden method (see A.2 of GB 18279.1-2015,
A.3);
---Changed the procedure for overkill method (see B.2, B.2 of GB 18279.1-2015);
---Changed the number of sensors and biological indicators (see Table C.1 and Table C.3, Table C.1 and Table C.3 of GB 18279.1-2015);
---Added content related to single-batch release (see Appendix E).
This document has been modified to adopt ISO 11135.2014 "Development and validation of ethylene oxide medical device sterilization processes for sterilization of healthcare products".
Accreditation and routine control requirements.
The technical differences between this document and ISO 11135.2014 and their reasons are as follows.
---Changed the description of the requirements for healthcare institutions in the scope (see 1.1) to avoid the mandatory requirements of standards and regulatory requirements
conflict with;
---Deleted the term "medical device" (see 3.21 of ISO 11135.2014) to avoid conflict with Chinese regulations;
---Changed the expression of the term "log reduction value of spores" (see 3.41) to make it easier to understand;
---Deleted the exception condition for parsing (if used) process variable control (see 6.2.5 of ISO 11135.2014) to standardize the process
Control requirements;
---Deleted the designation of the method of proving that the resistance of the bioburden is less than the resistance of the biological indicator in the overkill method (see
B.1.4 of ISO 11135.2014) to avoid limiting the application of the standard;
---Informative references to other international standards in 4.1.2, 4.3.1, 4.3.2, 4.3.3, 4.4, 7.3.2, 8.9, 11.3, 11.4, and E.1
Changed to note to adapt to my country's national conditions.
The following editorial changes have been made to this document.
---Incorporated the amendments to ISO 11135.2014/Amd.1.2018, the outer margins of the clauses involved are marked with vertical
Straight double lines (‖) are marked;
---Deleted the note in 1.2.2 to adapt to my country's national conditions;
---Replaced ISO 13485.2016 with YY/T 0287-2017 to adapt to my country's national conditions;
---Move the note referring to Appendix E in 11.4 into the text to be consistent with the normative Appendix E;
---Simplified the description of A.2 to make the standard terms clearer;
---Added the management specifications of health care institutions for reference in the applicable guidelines (see note in D.4.2.2).
---Added two notes in D.5.5.1 to better describe the combustion and explosion situation of ethylene oxide;
---Change the interpretation of D.12.5 to refer to YY/T 1268 to make the standard content easier to understand.
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed and managed by the National Medical Products Administration.
The previous versions of this document and the documents it replaces are as follows.
---First released in.2000 as GB 18279-2000;
---The first revision in.2015 was GB 18279.1-2015, GB/T 18279.2-2015;
---This is the second revision.
introduction
A sterile medical device is a product that is free of viable microorganisms. When a medical device must be provided in a sterile form, it should be sterilized before
Minimize any unintended microbial contamination. Even if medical device products meet the quality management system (for example. YY/T 0287-
2017), they will still contain a small amount of microorganisms before sterilization. Such products are non-sterile products. destroy
The purpose of sterilization is to inactivate microorganisms, thereby converting non-sterile products into sterile products.
The sterilization kinetics of using physical methods or chemical agents to inactivate pure cultured microorganisms on medical devices can often be determined by surviving microorganisms.
The exponential relationship between the number of organisms and the degree of ethylene oxide treatment is illustrated, which means that regardless of the degree of treatment, microorganisms always
Will survive with a limited probability. For an applied treatment, the probability of microbial survival is determined by the number of microorganisms, their resistance, and the
Determined by the environment in which microorganisms exist during treatment. It can be seen that the sterility of any product in a group of products that has been sterilized is
The sterility of this group of products cannot be guaranteed, but the sterility of this group of products can be determined based on the probability of microorganisms surviving on a product.
This document describes the requirements for ethylene oxide sterilization processes for medical devices. If these requirements are met, medical devices can be epoxy
Ethane sterilization properly kills microorganisms; in addition, it also ensures that the killing of microorganisms is reliable and repeatable, so that there is sufficient
Rationale Prediction. The probability of viable microorganisms on sterilized products is very low.
For the general requirements of quality management systems such as design and development, production, installation and service, see GB/T 19001-2016, and for special requirements, see
YY/T 0287-2017.These quality management system standards recognize that some processes in manufacturing are not
Sterilization is such a special process that requires inspection and testing to verify. Therefore, sterilization confirmation should be carried out before sterilization, and routine monitoring and equipment should be performed.
Ready for maintenance.
Implementing appropriate sterilization confirmation and accurately controlling the sterilization process are not the only reliable guarantees that the product is sterile and suitable for its intended use. Still need
Consider the following.
a) Microbiological status of the raw materials and/or components used;
b) Routine control and validation of cleaning and disinfection procedures for products;
c) Control of product manufacturing, assembly and packaging environments;
d) Control of equipment and processes;
e) Control of personnel and their hygiene;
f) Product packaging methods and packaging materials;
g) Storage conditions of the product.
Different types of contamination on the product to be sterilized can affect the effectiveness of the sterilization process. According to the manufacturer's instructions (see YY/T 0802-
2020), healthcare products that can be resterilized should be considered a special case. Although these products have been processed through the cleaning process, they may still contain
There are large amounts of contaminating microorganisms and residues of inorganic and/or organic contaminants. Therefore, during reprocessing, special attention should be paid to cleaning and disinfection
Confirmation and control of the process are very important.
The normative part of this document and its requirements are mandatory. The guidance given in the informative appendix is not normative and does not serve as a reviewer
Checklist. Appendix D provides appropriate methods for interpreting and complying with the requirements of the standard. In addition to the methods given in the guide, other methods if
If it is also in compliance with the requirements of this document and is valid, it can also be used.
The development, validation and routine control of a sterilization process encompasses several discrete but related activities, such as. calibration, maintenance, product definition, process
process definition, installation qualification, operational qualification and performance qualification. The activities required by this document are grouped together in a certain order, but do not need to
The order in which these activities are performed must be consistent with the order in which they appear in the standard. Developed and validated procedures may be implemented iteratively and therefore
These activities are not necessarily sequential. Implementation of different activities may require a number of separate individuals and/or organizations, each of whom may
Ability to undertake one or more activities. This document does not mandate that any particular individual or organization perform any particular activity.
When the product is used normally, the minimum amount of ethylene oxide and its by-products is very important to protect patient safety. GB/T 16886.7-
2015 stipulates the allowable residue limits for ethylene oxide and 2-chloroethanol (ECH). However, the residue limit of ethylene glycol (EG) is not required in the standard.
request because the risk assessment indicates that biologically significant ethylene glycol residues are unlikely to occur when ethylene oxide residues are controlled.
Healthcare Products Sterilization Ethylene Oxide Medical Devices
Requirements for the development, validation and routine control of sterilization processes
1 Scope
1.1 Applicable
This document specifies the development, validation and routine control requirements for the ethylene oxide sterilization process during the manufacturing process of medical device products. It is applicable to
Medical devices sterilized with ethylene oxide.
Note 1.There are commonalities and differences between the product manufacturing process and the sterilization process development, validation and routine control in healthcare institutions. The ethylene oxide in healthcare institutions
Please refer to this document for the alkane sterilization process. The similarities are the general requirements for quality systems, personnel training and appropriate safety measures; the main areas
Specifically related to the unique hardware environment and organizational conditions of healthcare facilities, as well as the initial conditions of reusable medical devices for sterilization.
Note 2.Healthcare facilities are in agreement with medical device manufacturers regarding the hardware design of the sterilization area, the equipment used, and personnel with adequate training and experience.
different. The main function of a healthcare institution is to provide healthcare services to patients, and the reprocessing of medical devices is just one of the countless activities that support this function.
One of the moves.
Note 3.In terms of the initial condition of medical devices, medical device manufacturers usually sterilize similar medical devices starting from raw materials and mass-producing them.
On the other hand, healthcare facilities must handle and process both new and reused medical devices with varying bioburden levels.
Face the additional challenge of cleaning, evaluating, preparing and packaging medical devices prior to sterilization. This document recommends sterilization process development,
Alternative methods and guidance for validation and control.
Note 4.Ethylene oxide gas and its mixtures are effective sterilants and are mainly used for medical devices that are sensitive to heat and/or water vapor and cannot be sterilized by moist heat.
Note 5.Although this document is limited to medical devices, the requirements specified in the standard and the guidance provided can also be applied to other healthcare products.
1.2 Not applicable
1.2.1 This document does not apply to the development and development of causative agent inactivation processes for spongiform encephalopathies (such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease).
Validation and routine controls.
Note. See YY/T 0771.1, YY/T 0771.2 and YY/T 0771.3.
1.2.2 This document does not specify specific requirements for medical devices labeled as sterile.
1.2.3 This document does not specify a quality management system that controls all stages of medical device production.
Note. The development, validation and routine control of medical device sterilization processes require the effective implementation of defined and documented procedures. These programs are often used as quality
Elements of a management system. This document does not require a complete quality management system during manufacturing or reprocessing. Necessary elements in this document are appropriate
The location is normatively cited (Chapter 4). Attention needs to be paid to quality management system standards that control all stages of production or reprocessing of medical devices (see
YY/T 0287-2017).
1.2.4 This document does not specify occupational safety requirements related to the design and operation of ethylene oxide sterilization facilities.
Note. Ethylene oxide is toxic, flammable, and explosive. For more information on safety, please see the references.
1.2.5 This document does not cover sterilization by directly injecting ethylene oxide or its gas mixture into product packaging or flexible cabinets.
1.2.6 This document does not contain analytical methods for determining residual levels of ethylene oxide and/or its reaction products.
Note. For detailed information, see GB/T 16886.7-2015.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
......
GB 18279.1-2015
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
GB 18279.1-2015 / ISO 11135-1.2007
Replacing GB 18279-2000
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)
ISSUED ON. DECEMBER 10, 2015
IMPLEMENTED ON. JANUARY 01, 2017
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
Introduction... 6
1 Scope... 8
2 Normative References... 9
3 Terms and Definitions... 10
4 Quality Management Systems... 18
5 Sterilizing Agent Characterization... 19
6 Process and Equipment Characterization... 19
7 Product Definition... 21
8 Process Definition... 23
9 Validation... 24
10 Routine Monitoring and Control... 29
11 Product Release from Sterilization... 30
12 Maintaining Process Effectiveness... 30
Annex A (Normative) Determination of Lethal Rate of the Sterilization Process -
Biological Indicator/Bioburden Approach... 33
Annex B (Normative) Conservative Determination of Lethal Rate of the Sterilization
Process - Overkill Approach... 36
Annex C (Informative) General Guidance... 38
Bibliography... 58
Foreword
All the technical contents of this Part of GB 18279 are mandatory.
GB 18279 Sterilization of Health Care Products – Ethylene Oxide consists of the following
parts.
--- Part 1.Requirements for Development, Validation and Routine Control of a Sterilization
Process for Medical Devices
--- Part 2.Guidance on the Application of GB 18279.1.
This Part is Part 1 of GB 18279.
This Part was drafted as per the rules specified in GB/T 1.1-2009.
Together with GB/T 18279.2, this Part replaced GB 18279-2000 Medical Devices – Validation
and Routine Control of Ethylene Oxide Sterilization. The major differences between this Part
and GB 18279-2000 are as follows.
--- Add some terms;
--- Add technical content such as sterilization factor characteristics, product definition,
process definition, installation identification, operation identification, and maintaining
the effectiveness of the sterilization process;
--- Make more specific and refined technical requirements such as performance
identification, routine monitoring and control, etc.;
--- Add guidelines for implementing the ethylene oxide sterilization process.
This Part equivalently adopted ISO 11135-1.2007 Sterilization of Health Care Products –
Ethylene Oxide – Part 1.Requirements for Development, Validation and Routine Control of a
Sterilization Process for Medical Devices.
The Chinese documents that have consistent correspondence with the international documents
normatively cited in this part are as follows.
--- GB/T 16886.1-2011 Biological Evaluation of Medical Devices - Part 1.Evaluation and
Testing within a Risk Management Process (ISO 10993-1.2009, IDT);
--- GB/T 16886.7-2001 Biological Evaluation of Medical Devices - Part 7.Ethylene Oxide
Sterilization Residuals (ISO 10993-7.1995, IDT);
--- GB 18281.1-2015 Sterilization of Health Care Products - Biological Indicators - Part 1.
General Requirements (ISO 11138-1.2006, IDT);
--- GB 18282.1-2015 Sterilization of Health Care Products - Chemical Indicator - Part 1.
General Requirements (ISO 11140-1.2005, IDT);
--- GB/T 19022-2003 Measurement Management Systems—Requirements for
Measurement Processes and Measuring Equipment (ISO 10012.2003, IDT);
--- GB/T 19972-2005 Sterilization of Health Care Products - Biological Indicators -
Guidance for the Selection, Use and Interpretation of Results (GB/T 19972, ISO
14161.2000, IDT);
--- GB/T 19973.1-2015 Sterilization of Medical Devices - Microbiological Methods - Part
1.Determination of a Population of Microorganisms on Products (ISO 11737-1.2006,
IDT);
--- GB/T 19973.2-2005 Sterilization of Medical Devices - Microbiological Methods - Part
2.Tests of Sterility Performed in the Validation of a Sterilization Process (ISO 11737-
2.1998, IDT);
--- YY/T 0287-2003 Medical Devices - Quality Management Systems – Requirements for
Regulatory Purposes (ISO 13485.2003, IDT).
The following editorial modifications have been made to this Part.
--- Some editorial modifications have been made in accordance with the requirements of
GB/T 1.1;
--- Delete the Foreword of the International Standard;
--- Replace some international standards appearing in the Introduction and Bibliography
with corresponding Chinese standards.
Please note some contents of this Document may involve patents. The issuing agency of this
Document shall not assume the responsibility to identify these patents.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee on Disinfection
Technology and Equipment of Standardization Administration of China (SAC/TC 200).
Drafting organizations of this Part. Hangzhou Unique Disinfection Equipment Co., Ltd.;
Guangzhou Medical Devices Quality Surveillance and Test Center of State Food and Drug
Administration; Terumo Medical Products (Hangzhou) Co., Ltd.; Sterigenics Shanghai ETO
Ltd.; and Guangzhou Improve Medical Instruments Co., Ltd.
Chief drafting staffs of this Part. Zhou Qingqing, Chen Zhiling, Hu Changming, Lin Yuqing,
Weng Hui, Xu Haiying, Gao Li, Min Jie, and Gong Yaoren.
The historical edition replaced by this Part is as follows.
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 1.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 ethylene oxide sterilization 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 Indicators - 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 Procedure (ISO 14937.2000, IDT)
ISO 10012 Measurement Management Systems – Requirements for Measurement Process
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.
......
| Standard ID | GB 18279-2023 (GB18279-2023) | | Description (Translated English) | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices | | Sector / Industry | National Standard | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 58,523 | | Date of Issue | 2023-09-08 | | Date of Implementation | 2026-10-01 | | Older Standard (superseded by this standard) | GB 18279.1-2015,GB/T 18279.2-2015 | | Administrative Organization | State Drug Administration | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration | | Standard ID | GB 18279.1-2015 (GB18279.1-2015) | | Description (Translated English) | Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | | Sector / Industry | National Standard | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 39,312 | | Date of Issue | 2015-12-10 | | Date of Implementation | 2017-01-01 | | Older Standard (superseded by this standard) | GB 18279-2000 | | Quoted Standard | GB 18281.2-2015; GB/T 19974-2005; GB/T 19022-2003; GB/T 16886.1-2011; GB/T 16886.7-2001; GB 18281.1-2015; GB 18282.1-2015; GB/T 19973.1-2015; GB/T 19973.2-2005; YY/T 0287-2003; GB/T 19972-2005 | | Adopted Standard | ISO 11135-1-2007, IDT | | Drafting Organization | Shandong Xinhua Medical Instrument Co., Ltd; Michael Di Jincheng Medical Devices Co., Ltd; Guangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center; Belimed Medical Equipment (Shanghai) Co., Ltd. | | Administrative Organization | National disinfection technology and equipment Standardization Technical Committee (SAC/TC 200) | | Regulation (derived from) | National Standard Announcement 2015 No.38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China | | Summary | This standard specifies the development of medical devices ethylene oxide sterilization process, validation and routine control. In accordance with the requirements of this standard and to confirm the sterilization process control can not be inferred to be effective inactivation of pathogenic factors spongiform encephalopathy, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Some countries have developed detailed recommendations deal with possible contaminants by such factors. This standard does not detailing marked as sterile medical instruments specific requirements. The standard does not specify all the stages of production of medical devices for the control of the quality management system. This standard does not specify with ethylene oxide sterilization facility design and operation-related occupational safety requirements. This standard does not include ethylene oxide or mixtures containing ethylene oxide sterilization is directly injected into a single product packaging, or continuous sterilization process. This standard does not include a determination of ethylene oxide and/or analysis of the reaction product residue levels. | | Standard ID | GB 18279-2000 (GB18279-2000) | | Description (Translated English) | Medical devices. Validation and routine control of ethylene oxide sterilization | | Sector / Industry | National Standard | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080 | | Word Count Estimation | 27,244 | | Date of Issue | 2000/12/13 | | Date of Implementation | 2001-05-01 | | Quoted Standard | GB 18281.1-2000; GB/T 19001-1994; GB/T 19002-1994; GB/T 19004.1-1994; ISO 10993.7-1995 | | Adopted Standard | ISO 11135-1994, IDT | | Drafting Organization | State Drug Administration of Guangzhou Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National disinfection technology and equipment Standardization Technical Committee | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Quality and Technical Supervision | | Summary | This Chinese standard specifies the medical device ethylene oxide (EO) sterilization process Validation and routine control requirements and guidelines. |
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