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GB 18279-2023: Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 18279-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
CCS C 47
Replacing GB 18279.1-2015, GB/T 18279.2-2015
Sterilization of health-care products - Ethylene oxide -
Requirements for the development, validation and routine
control of a sterilization process for medical devices
(ISO 11135:2014, MOD)
ISSUED ON: SEPTEMBER 08, 2023
IMPLEMENTED ON: OCTOBER 01, 2026
Issued by: State Administration for Market Regulation;
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 system ... 19
5 Characteristics of sterilizing agents ... 20
6 Process and device characteristics ... 21
7 Product definition ... 23
8 Process definition ... 25
9 Validation ... 26
10 Routine monitoring and control ... 33
11 Sterilization release of products ... 34
12 Maintenance of effectiveness of sterilization process ... 35
Annex A (normative) Determination of kill rate of sterilization process - Biological
indicator/bioburden method ... 37
Annex B (normative) Method for determining conservativeness of kill rate in
sterilization process - Overkill approach ... 40
Annex C (informative) Temperature sensors, humidity sensors and biological indicators
... 42
Annex D (informative) Guidance on the application of normative requirements ... 46
Annex E (normative) Single batch release ... 95
Bibliography ... 99
Sterilization of health-care products - Ethylene oxide -
Requirements for the development, validation and routine
control of a sterilization process for medical devices
1 Scope
1.1 Application
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 by ethylene oxide.
NOTE 1: There are similarities and differences in the development, validation, and routine control
of sterilization processes in product manufacturing and health care facility. This document can be
used as a reference for ethylene oxide sterilization processes in health care facility. The similarities
are the general requirements for quality systems, personnel training, and appropriate safety measures.
The main differences involve the unique physical and organizational conditions of health care
facility, as well as the initial conditions of reusable medical devices for sterilization.
NOTE 2: Health care facilities differ from medical device manufacturers in the hardware design of
sterilization areas, the equipment used, and the personnel with adequate training and experience.
The primary function of a health care facility is to provide health care services to patients.
Reconditioning of medical devices is only one of countless activities that support this function.
NOTE 3: In terms of the initial condition of medical devices, medical device manufacturers
typically sterilize batches of similar medical devices starting from virgin materials. On the other
hand, health care facilities handle and process both new and reused medical devices with varying
bioburden levels and are therefore faced with the additional challenge of cleaning, evaluating,
preparing, and packaging medical devices prior to sterilization. This document recommends
alternative approaches and guidance for the development, validation, and control of sterilization
processes for health care facilities.
NOTE 4: Ethylene oxide gas and its mixtures are effective sterilants, mainly used for medical
devices that are sensitive to heat and/or moisture and cannot be sterilized by moist heat.
NOTE 5: Although this document is limited to medical devices, the requirements specified and
guidance provided by the standard may also be applicable to other health care products.
1.2 In-application
1.2.1 This document is not applicable to the development, validation and routine control
of processes for inactivating the causative agents of spongiform encephalopathies (e.g.,
scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease).
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 production of medical devices.
NOTE: The development, validation and routine control of sterilization processes for medical
devices require the effective implementation of defined and documented procedures. These
procedures are usually elements of a quality management system. This document does not require
a complete quality management system to be in place during manufacturing or reprocessing.
Necessary elements are normatively referenced at appropriate locations in this document (Chapter
4). Attention shall be paid to the quality management system standards that control all stages of
medical device production or reprocessing (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, see
references.
1.2.5 This document does not cover sterilization by direct injection of ethylene oxide
or its gas mixtures into product packaging or flexible chambers.
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 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 18281.1-2015, Sterilization of health care products - Biological indicators - Part
1: General requirements (ISO 11138-1:2006, 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)
4.3.2 Product identification and traceability procedures shall be specified.
NOTE: These procedures are described in the applicable provisions of YY/T 0287-2017.
4.3.3 Calibration procedures for all equipment (including test instruments) used to meet
the requirements of this document shall be specified.
NOTE: For procedures, see the applicable provisions of YY/T 0287-2017 or GB/T 19022-2003.
4.4 Measurement, analysis and improvement - Nonconforming product control
Procedures shall be defined for the control of nonconforming product and for correction,
corrective action and preventive action.
NOTE: These procedures are described in the applicable provisions of YY/T 0287-2017.
5 Characteristics of sterilizing agents
5.1 General
The purpose of this clause is to define the sterilization agent, specify its sterilization
effect, identify factors that affect sterilization effect, evaluate the effects of the sterilant
on materials, and identify requirements for personnel safety and environmental
protection. These activities may be undertaken by test or prototype systems. Regardless
of where they are performed, the final device specification (see 6.3) shall be consis...