GB/T 18280.3-2025 Sterilization of health care products – Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
1 Scope
This document gives guidance on meeting the requirements in GB 18280.1 and GB/T 18280.2 and ISO 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.
This document is applicable to guidance on dosimetric aspects of development, validation and routine control of radiation sterilization process intended to sterilize medical devices.
Note: This document is applicable to medical devices, but the guidance on dose measurement of development, validation and routine control of radiation sterilization process may apply to other products.
2 Normative References
The following documents contain requirements which, through reference in this text, constitute provisions 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 18280.1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (GB 18280.1-2025, ISO 11137-1: 2025, MOD)
GB/T 18280.2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (GB/T 18280.2-2025, ISO 11137-2: 2013, MOD)
3 Terms, definitions and symbols
For the purposes of this document, the terms and definitions as all as symbols given in GB 18280.1 and GB/T 18280.2 and the following apply.
3.1 Terms and definitions
3.1.1
absorbed dose
dose
quantity of ionizing radiation energy imparted per unit mass of a specified material
Note: For the purposes of this document, the term “dose” is used to mean “absorbed dose”.
[Source: GB 18280.1-2025, 3.1, modified]
3.1.2
combined standard uncertainty
standard measurement uncertainty (3.1.13) that is obtained using the individual standard measurement uncertainties associated with the input quantities in a measurement model
[Source: VIM 2012, 2.31]
3.1.3
coverage factor
number larger than one by which a combined standard measurement uncertainty (3.1.2) is multiplied to obtain an expanded measurement uncertainty (3.1.7)
Note: A coverage factor is usually symbolized as “k” (see also the GUM:1995, 2.3.6).
3.1.4
direct dose measurement
measurement of absorbed dose (3.1.1) with a dosimeter at the location of interest
Note: For example, a direct measurement of minimum dose is made with a dosimeter at the minimum dose location in an irradiation container.
3.1.5
dose uniformity ratio
ratio of the maximum to the minimum absorbed dose (3.1.1) within the irradiation container
3.1.6
dosimetry system
interrelated elements used for determining absorbed dose, including dosimeters, instruments, associated reference standards and procedures for their use
[Source: GB/T 19971-2015, 2.15, modified]
3.1.7
expanded measurement uncertainty
product of a combined standard measurement uncertainty (3.1.2) and a factor larger than the number one
Note 1: The factor depends on the type of probability distribution of the output quantity in a measurement model and on the selected coverage probability.
Note 2: The term “factor” in this definition refers to a coverage factor.
3.1.8
indirect dose measurement
measurement of absorbed dose (3.1.1) at a location remote from a directly measured dosimeter, calculated by the application of factors
Note: For example, where the minimum dose in an irradiation container cannot easily be measured directly, a dosimeter placed in a remote location may be measured and factors applied to that measurement to calculate the minimum dose
3.1.9
scan length
dimension of the irradiation zone, perpendicular to the scan width and direction of the electron beam at a specified distance from the accelerator window
Note: ISO/ASTM standards use “beam length” to mean the same thing that “scan length” means in this document. This document uses “scan length” for consistency with GB 18280.1.
3.1.10
scan width
dimension of the irradiation zone in the direction that the beam is scanned, perpendicular to the scan length and direction of the electron beam at a specified distance from the accelerator window
Note: ISO/ASTM standards use “beam width” to mean the same thing that “scan width” means in this document.
3.1.11
simulated product
material with attenuation and scattering properties similar to those of the product, material or substance to be irradiated
Note 1: Simulated product is used as a substitute for the actual product, material or substance to be irradiated. When used in routine production runs in order to compensate for the absence of product, simulated product is sometimes referred to as compensating dummy When used for absorbed dose mapping, simulated product is sometimes referred to as “phantom material”.
Note 2: In this document, “dose mapping” is used for “absorbed dose mapping.”
3.1.12
spatial resolution
resolution in two dimensions
Contents
Foreword i
Introduction iv
1 Scope
2 Normative References
3 Terms, definitions and symbols
4 Measurement of dose
5 Establishing the maximum acceptable dose
6 Establishing the sterilization dose
7 Installation qualification
8 Operational qualification
9 Performance qualification (PQ)
10 Routine monitoring and control
Annex A (informative) Application of dose measurement uncertainty in setting process target doses
Annex B (informative) Tolerances associated with doses used in sterilization dose setting/substantiation in GB/T 18280.2 and ISO 13004
Annex C (informative) Tables of references for dosimetry-related testing during IQ/OQ/PQ
Annex D (informative) Mathematical modelling
Bibliography
