GB/T 19973.2-2025 PDF English
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Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process
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GB/T 19973.2-2025: Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
CCS C 47
GB/T 19973.2-2025 / ISO 11737-2.2019
Replacing GB/T 19973.2-2018
Sterilization of health care products - Microbiological
methods - Part 2.Tests of sterility performed in the
definition, validation and maintenance of a sterilization
process
(ISO 11737-2.2019, IDT)
Issued on: JANUARY 24, 2025
Implemented on: FEBRUARY 01, 2026
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 7
2 Normative references... 7
3 Terms and definitions... 7
4 General requirements... 11
5 Selection of product... 12
6 Method for performing tests of sterility... 14
7 Assessment of the method for performing tests of sterility... 15
8 Maintenance of the method for performing tests of sterility... 15
Appendix A (Informative) Guidance on tests of sterility performed in validation and
maintenance of a sterilization process... 16
Appendix B (Informative) Typical allocation of responsibilities... 25
Bibliography... 26
Foreword
This document was drafted in accordance with the rules given in GB/T 1.1-2020,
Directives for standardization - Part 1.Rules for the structure and drafting of
standardizing documents.
This document is part 2 of GB/T 19973.The following parts have been issued under
GB/T 19973.
-- Sterilization of health care products - Microbiological methods - Part 1.
Determination of a population of microorganisms on products;
-- Sterilization of health care products - Microbiological methods - Part 2.Tests
of sterility performed in the definition, validation and maintenance of a
sterilization process.
This document serves as a replacement of GB/T 19973.2-2018 Sterilization of medical
devices - Microbiological methods - Part 2.Tests of sterility performed in the definition,
validation and maintenance of a sterilization process. In comparison with GB/T
19973.2-2018, apart from structural adjustments and editorial modifications, the main
technical changes are as follows.
-- Add clauses on the scope of non-applicability of this document [see 1.2c)];
-- Add the terms and definitions of “aseptic technique”, “health care product”
and “method suitability” (see 3.1, 3.6 and 3.8);
-- Delete the terms and definitions of “aerobic organism”, “anearobic organism”
and “growth promotion test” (see 3.1, 3.2 and 3.7 of the 2018 edition);
-- Change the terms and definitions of “test for sterility” and “test of sterility”
(see 3.12 and 3.13; 3.12 and 3.13 of the 2018 edition);
-- Change the content of “elements of the quality management system” and
change the title to “General requirements” (see Chapter 4; Chapter 4 of the
2018 edition);
-- Add the requirement for the rational for the number of product items that are
selected and the number of batches from which this selection is made shall be
documented (see 5.1.3);
-- Add the rational for calculating sample item portion (see 5.2.3);
-- Add the requirement that the product shall remain immersed in the culture
medium during the incubation period, and if this is not possible (e.g. the
material has buoyancy), corresponding rationale shall be given [see 6.1a)];
Sterilization of health care products - Microbiological
methods - Part 2.Tests of sterility performed in the
definition, validation and maintenance of a sterilization
process
1 Scope
1.1 This document specifies the general criteria for tests of sterility on medical devices
that have been exposed to a treatment with the sterilizing agent at levels lower than
those normally used in sterilization processes. This document is applicable to the
definition, validation or maintenance of a sterilization process.
1.2 This document is not applicable to.
a) test for sterility of sterilized products prior to routine release;
b) implementation of test for sterility (see 3.12);
Note 1.ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-
1 and ISO 20857 do not require the performance of tests referred to in a) or
b).
c) test for sterility or test of sterility for demonstration of product shelf life,
stability and/or package integrity;
d) culturing of biological indicators or inoculated products.
Note 2.ISO 11138-7 provides guidance on culturing biological indicators.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the
following addresses.
3.10
sample item portion; SIP
Specified part of a health care product, which is used for testing.
[Source. ISO 11139.2018, 3.240, modified]
3.11
sterile
Free from viable microorganisms.
[Source. ISO 11139.2018, 3.271]
3.12
test for sterility
Technical operation performed on the product according to the pharmacopoeia
regulations after the product has been aseptically processed or sterilized.
[Source. ISO 11139.2018, 3.298]
3.13
test of sterility
A technical operation required during development, validation or requalification to
determine whether a product or its fraction contains viable microorganisms.
Note. This test is performed after treatment with the sterilizing agent at a level lower
than that of the complete sterilization process.
[Source. ISO 11139.2018, 3.299, modified]
4 General requirements
4.1 The development, validation, and routine control of a sterilization process is a
critical element in product realization of health care products. To ensure consistent
implementation of the requirements specified in this document, the necessary processes
need to be established, implemented and maintained (see Appendix B). Procedures of
particular importance in relation to the development, validation, and routine control of
a sterilization process include, but are not limited to.
-- control of documentation, including related records;
-- assignment of management responsibilities;
-- reasonable resource supply, including competent human resources and
infrastructure;
-- control of externally supplied products;
-- identification and traceability of products throughout the process;
-- control of non-conforming products.
Note. For regulatory purposes, ISO 13485 covers all stages of the medical device
life cycle in terms of quality management systems. Depending on the supply
requirements of health care products under relevant regulations, it may be
required to implement a complete quality management system and have it
assessed by a recognized conformity assessment body.
4.2 A calibration procedure for all equipment, including test instruments, shall be
established to meet the requirements of this document.
5 Selection of product
5.1 General requirements
5.1.1 The procedures for selection and handling of samples for tests of sterility shall
ensure that the samples selected are representative of routine production, including
packaging materials and all production processes (see 5.3).
5.1.2 During the development, validation and routine control of the sterilization process,
if it is necessary to classify one or more products into a product family for tests of
sterility, the rationale for inclusion of a product within a product family shall be
recorded. The rational shall include selection criteria to ensure that the products selected
from a product family for testing are representative of the whole product family.
5.1.3 The rational for the number of product items that are selected and the number of
batches from which this selection is made shall be documented.
Note. The above information can be found in the standards related to the validation
and routine control requirements of the sterilization process.
5.2 Sample item portion
5.2.1 Where applicable, the test of sterility shall be performed on the entire product.
However, if the applicable sterilization standard permits, a selected portion of the
product (sample item portion) may be used instead of the entire product in the test of
sterility.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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