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 (English Version)
Sterilization of health care products—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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
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 which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
1.2 This document is not applicable to:
a) test for sterility before routine release of product that has been subjected to a sterilization process;
b) performing a test for sterility (see 3.12);
Note 1: The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.
c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity; and
d) culturing of biological indicators or inoculated products.
Note 2: Guidance on culturing biological indicators is included in ISO 11138-7.
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:
—IEC Electropedia: available at http://www.electropedia.org/;
—ISO Online browsing platform: available at http://www.iso.org/obp.
3.1
aseptic technique
conditions and procedures used to minimize the risk of the introduction of microbial contamination
[Source: ISO 11139:2018, 3.16]
3.2
bacteriostasis/fungistasis test
technical operation performed to detect the presence of substances that inhibit microbial multiplication
[Source: ISO 11139:2018, 3.20]
3.3
bioburden
population of viable microorganisms on or in a product and/or sterile barrier system
[Source: ISO 11139:2018, 3.23]
3.4
culture condition
combination of growth media and manner of incubation used to promote germination, growth and/or multiplication of microorganisms
Note: The manner of incubation can include the temperature, time, and any other conditions specified for incubation.
[Source: ISO 11139:2018, 3.70]
3.5
facultative microorganism
microorganism capable of both aerobic and anaerobic metabolism
[Source: ISO 11139:2018, 3.114]
3.6
health care product
medical device (3.7), including in vitro diagnostic medical device, or medicinal product, including biopharmaceutical
[Source: ISO 11139:2018, 3.132]
3.7
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, or software material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
—diagnosis, prevention, monitoring, treatment or alleviation of disease;
—diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
—investigation, replacement, modification or support of the anatomy or of a physiological process;
—supporting or sustaining life;
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Selection of product
6 Methods for performing tests of sterility
7 Assessment of the method for performing tests of sterility
8 Maintenance of the method for performing tests of sterility
Annex A (Informative) Guidance on tests of sterility performed in validation and maintenance of a sterilization process
Annex B (Informative) Typical assignment of responsibilities
Bibliography
Standard
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 (English Version)
Standard No.
GB/T 19973.2-2025
Status
to be valid
Language
English
File Format
PDF
Word Count
10500 words
Price(USD)
315.0
Implemented on
2026-2-1
Delivery
via email in 1 business day
Detail of GB/T 19973.2-2025
Standard No.
GB/T 19973.2-2025
English Name
Sterilization of health care products—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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
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 which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
1.2 This document is not applicable to:
a) test for sterility before routine release of product that has been subjected to a sterilization process;
b) performing a test for sterility (see 3.12);
Note 1: The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.
c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity; and
d) culturing of biological indicators or inoculated products.
Note 2: Guidance on culturing biological indicators is included in ISO 11138-7.
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:
—IEC Electropedia: available at http://www.electropedia.org/;
—ISO Online browsing platform: available at http://www.iso.org/obp.
3.1
aseptic technique
conditions and procedures used to minimize the risk of the introduction of microbial contamination
[Source: ISO 11139:2018, 3.16]
3.2
bacteriostasis/fungistasis test
technical operation performed to detect the presence of substances that inhibit microbial multiplication
[Source: ISO 11139:2018, 3.20]
3.3
bioburden
population of viable microorganisms on or in a product and/or sterile barrier system
[Source: ISO 11139:2018, 3.23]
3.4
culture condition
combination of growth media and manner of incubation used to promote germination, growth and/or multiplication of microorganisms
Note: The manner of incubation can include the temperature, time, and any other conditions specified for incubation.
[Source: ISO 11139:2018, 3.70]
3.5
facultative microorganism
microorganism capable of both aerobic and anaerobic metabolism
[Source: ISO 11139:2018, 3.114]
3.6
health care product
medical device (3.7), including in vitro diagnostic medical device, or medicinal product, including biopharmaceutical
[Source: ISO 11139:2018, 3.132]
3.7
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, or software material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
—diagnosis, prevention, monitoring, treatment or alleviation of disease;
—diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
—investigation, replacement, modification or support of the anatomy or of a physiological process;
—supporting or sustaining life;
Contents of GB/T 19973.2-2025
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Selection of product
6 Methods for performing tests of sterility
7 Assessment of the method for performing tests of sterility
8 Maintenance of the method for performing tests of sterility
Annex A (Informative) Guidance on tests of sterility performed in validation and maintenance of a sterilization process
Annex B (Informative) Typical assignment of responsibilities
Bibliography
