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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 consistent
with the results of the test or prototype device studies. The sterilization agent referred
to in this document is ethylene oxide.
5.2 Sterilant
If applicable, the sterilant specification shall include the required storage conditions for
ethylene oxide during its shelf life.
5.3 Effectiveness in killing microorganisms
If ethylene oxide outside the recognized composition range is used or a new diluent is
used, data on microbiological effectiveness shall be developed.
NOTE: The microbial inactivation performance of ethylene oxide is well documented in the
literature. This literature provides knowledge of the effects of process variables on microbial
inactivation. This document does not claim to reference such comprehensive studies of microbial
inactivation.
5.4 Material impact
The effects of ethylene oxide on most materials used to manufacture medical devices
have been thoroughly documented. This documentation is valuable in the design and
development of medical devices that are sterilized using ethylene oxide. This document
does not require specific studies on the effects of ethylene oxide on materials, but does
require studies on the effects of ethylene oxide on products (see Chapter 7).
5.5 Safety and environment
5.5.1 Material Safety Data Sheet (MSDS) or similar safety information shall be
provided for ethylene oxide and its diluent (if any). Necessary measures to protect
personnel safety and health shall be identified.
5.5.2 The potential impact of the sterilization process on the environment shall be
assessed and measures to protect the environment shall be identified. The assessment
including potential impacts and control measures shall be documented.
5.5.3 Attention shall be paid to the discharge and conditioning of ethylene oxide, its
diluents and any by-products.
6 Process and device characteristics
6.1 General
6.1.1 The purpose of this clause is to define the complete sterilization process necessary
and the equipment necessary to enable the sterilization process to be carried out safely
and reproducibly.
6.1.2 If a process already exists for sterilizing the product, this activity is not necessary.
However, the sterilization process and equipment shall be reviewed to ensure that the
variables defined in 6.2 and 6.3 are included in the process specifications for routine
production.
6.2 Process characteristics
6.2.1 Process characteristics, which shall at least include:
a) identification of the necessary stages of the ethylene oxide sterilization process;
b) identification of the process variables at each stage;
c) documentation of the process variables.
NOTE: Data developed during product definition (see Chapter 7) may influence the characteristics
of the sterilization process.
6.2.2 The stages of the sterilization process include:
a) preconditioning (if used);
chamber;
d) Description of the instruments used to monitor, control and record the sterilization
process, including sensor characteristics and locations;
e) Faults that can be identified by the sterilization equipment;
f) Safety features, including those for personal safety and environmental protection;
g) Installation requirements, including specifications for required services and
emission control requirements.
6.3.3 Software used for process control and/or monitoring shall be prepared and
validated in accordance with the requirements of the quality system elements. Written
evidence shall be provided to demonstrate that the software conforms to its design
specifications.
NOTE: For detailed information, see GB/T 19003-2018.
6.3.4 Methods for monitoring and controlling process variables shall be determined and
specified.
6.3.5 Methods shall be provided to ensure that failure of control functions does not
result in invalid process parameter records and to avoid invalid processes being
displayed as valid processes.
NOTE: Identification of deviations and indication of faults can be achieved by using independent
control and monitoring systems, or by mutual checking between control and monitoring systems.
7 Product definition
7.1 General
7.1.1 The purpose of this chapter is to define the products to be sterilized, including
their microbiological characteristics prior to sterilization and the packaging and
presentation of the products prior to sterilization.
7.1.2 A product definition shall be performed before introducing a new or changed
product, package or containment method. Demonstration of equivalence to previously
validated products, packages or containment methods (with reference to the challenge
of the sterilization process) shall be considered to satisfy the requirements of the
product definition. This demonstration of equivalence shall be documented.
7.1.3 The design of the product shall allow for the exclusion of air and, where applicable,
the penetration of heat, moisture and ethylene oxide during the sterilization process, as
well as the removal of ethylene oxide at the end of the process.
7.1.4 The design of the packaging shall allow for the exclusion of air, the penetration
of heat, moisture and ethylene oxide during the sterilization process, and the removal
of ethylene oxide at the end of the process.
7.1.5 The product loading pattern shall be designed to allow for the exclusion of air, the
penetration of heat, moisture and ethylene oxide during the sterilization process, and
the removal of ethylene oxide at the end of the process.
7.1.6 It shall be demonstrated that the specified sterilization process is effective in
sterilizing the most difficult-to-sterilize locations of the product. This can be achieved
through process definition and new product validation; or through demonstration of
equivalence with an already validated product; or through the use of an in-house process
challenge device to demonstrate that the specified sterilization process can meet the
product sterility assurance level requirements (see 8.6).
7.2 Product safety, quality and performance
7.2.1 The sterilization process shall be defined using the process parameters and
tolerances that have been identified as having the greatest impact on the
product/package. Confirm that the product and its packaging meet the specified safety,
quality and performance requirements.
NOTE: Design control in YY/T 0316-2016 is one aspect.
7.2.2 If multiple sterilization cycles are permitted, the effects of such conditionings on
the product and packaging shall be evaluated.
7.2.3 The biological safety of the product after exposure to the sterilization process ...