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GB 18279.1-2015 English PDF (GB18279.1-2015)

GB 18279.1-2015 English PDF (GB18279.1-2015)

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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

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.

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