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GB/T 19973.2-2018 PDF in English


GB/T 19973.2-2018 (GB/T19973.2-2018, GBT 19973.2-2018, GBT19973.2-2018)
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GB/T 19973.2-2018: PDF in English (GBT 19973.2-2018)

GB/T 19973.2-2018
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
GB/T 19973.2-2018 / ISO 11737-2:2009
Replacing GB/T 19973.2-2005
Sterilization of medical devices - Microbiological
methods - Part 2: Tests of sterility performed in the
definition, validation and maintenance of a
sterilization process
(ISO 11737-2:2009, IDT)
ISSUED ON: MARCH 15, 2018
IMPLEMENTED ON: APRIL 01, 2019
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine of the PRC;
Standardization Administration of the PRC.
Table of Contents
Foreword ... 3 
Introduction ... 7 
1 Scope ... 9 
2 Normative references ... 9 
3 Terms and definitions ... 10 
4 Quality management system elements ... 12 
5 Selection of product ... 13 
6 Methods for performing tests of sterility ... 14 
7 Assessment of method for performing tests of sterility ... 16 
8 Maintenance of the method for performing tests of sterility ... 16 
Annex A (Informative) Guidance on tests of sterility performed in validation and
maintenance of a sterilization process ... 17 
Bibliography ... 29 
Foreword
GB/T 19973 "Sterilization of medical devices - Microbiological methods" is
divided into the following 2 parts:
- Part 1: Determination of a population of microorganisms on products;
- Part 2: Tests of sterility performed in the definition, validation and
maintenance of a sterilization process.
This Part is Part 2 of GB/T 19973.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces GB/T 19973.2-2005 "Sterilization of medical devices -
Microbiological methods - Part 2: Tests of sterility performed in the validation of
a sterilization process". Compared with GB/T 19973.2-2005, the main technical
content changes of this Part are as follows:
- CHANGE "General" to "Quality management system elements" (see
Clause 4; Clause 4 of the 2005 edition);
- Modify the title of "Personnel" and its contents and change to "Management
responsibility" and related requirements (see 4.2; 4.2 of the 2005 edition);
- Modify the title of "Equipment and material" and its contents and change to
"Product realization" and related requirements (see 4.3; 4.3 of the 2005
edition);
- ADD "Measurement, analysis and improvement" (see 4.4);
- CHANGE "Selection and preparation of test product units" to "Selection of
product" (see Clause 5; Clause 5 of the 2005 edition);
- CHANGE "Selection" to "General" and separately list "Sample item portion
(SIP)" (see 5.1, 5.2; 5.1, 5.1.2 of the 2005 edition);
- CHANGE the title of "Packaging of product units and sample item portions"
to "Packaging of product and sample item portions" (see 5.3; 5.2 of the
2005 edition);
- CHANGE "Tests of sterility" to " Methods for performing tests of sterility"
(see Clause 6; Clause 6 of the 2005 edition);
- ADD requirements for the use of aseptic techniques in tests (see 6.3);
- ADD factors to be considered when selecting eluent or fluid product
separation (see 6.5);
- ADD time limit requirement (see 6.8);
- ADD requirement for results recording (see 6.9);
- Delete the requirement for review of test methods in "Assessment of
method for performing tests of sterility" (see 7.2 of the 2005 edition);
- ADD the title of "Maintenance of the method for performing tests of sterility"
and related content (see Clause 8);
- CHANGE the title of "Guidance on tests of sterility for validation of a
sterilization process" to "Guidance on tests of sterility performed in
validation and maintenance of a sterilization process" (see Annex A; Annex
A of the 2005 edition);
- CHANGE "Introduction" to "Scope" (see A.1; A.1 of the 2005 edition);
- ADD the title of "Normative references" and related content (see A.2);
- ADD the title of "Terms and definitions" and related content (see A.3);
- CHANGE the title of "Laboratory quality system" to "Quality management
system elements" (see A.4; A.2 of the 2005 edition);
- Delete the title of "Instruments and materials". Include its contents
"Electronic data processing" in "Documentation", and "Biological
instruments" and "Microbial growth medium" in "Product realization" (see
A.4.1, A.4.3; A.3.1, A.3.2, A.3.3 of the 2005 edition);
- ADD the title of "Management responsibility" and related content (see A.4.2);
- ADD the title of "Measurement, analysis and improvement" and related
content (see A.4.4);
- CHANGE "Selection and preparation of test product units" to "Selection of
product" (see A.5; A.4 of the 2005 edition);
- Modify the title of "Methods for selecting product units for validation" and its
contents and change to "General" and related requirements (see A.5.1;
A.4.1 of the 2005 edition);
- Delete the title of "Sample item portion of complete set of devices" and its
contents (A.4.3 of the 2005 edition);
- Modify the title of "Packaging of product units" and its contents and change
to "Packaging of product and sample item portions" and related
requirements (see A.5.3; A.4.4 of the 2005 edition);
- CHANGE the title of "Tests of sterility" to "Methods for performing tests of
sterility". Delete titles such as "Type", "Direct immersion", "Elution of
microorganisms", "Membrane filtration", "Eluent culture", "Selection of
culture conditions", "Check of growth medium after tests of sterility" and
include their contents in "Methods for performing tests of sterility" (see A.6,
A.6.1, A.6.4, A.6.5, A.6.7; A.5, A.5.1, A.5.2, A.5.3, A.5.4, A.5.5 of the 2005
edition);
- Delete the title of "Assessment of tests of sterility". Delete the titles of
"Assessment of false positives due to contamination during tests of sterility",
"Tests of microbicidal and/or microbiostatic substances", "Time between
sterilization and tests of sterility" and include their contents in "Methods for
performing tests of sterility" (see A.6.1, A.6.2.3, A.6.3 of the 2005 edition);
- Delete the title "Assessment of false negatives during tests of sterility" and
its contents (see A.6.2 of the 2005 edition);
- ADD the title of "Method for macroscopic examination of growth medium"
and related content (see A.6.9);
- ADD the title of "Assessment of method for performing tests of sterility" and
related content (see A.7);
- ADD the title of "Maintenance of the method for performing tests of sterility"
and related content (see A.8);
- Delete Table A.2 (Table A.2 of the 2005 edition).
This Part, using translation method, is identical to ISO 11737-2:2009
“Sterilization of medical devices - Microbiological methods - Part 2: Tests of
sterility performed in the definition, validation and maintenance of a sterilization
process”.
China’s documents which have a consistent correspondence with the
international documents normatively referenced in this Part are as follows:
- GB/T 19022-2003 Measurement management systems - Requirements for
measurement processes and measuring equipment (ISO 10012:2003, IDT)
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. The issuing authority of this document shall
not be held responsible for identifying any or all such patent rights.
Sterilization of medical devices - Microbiological
methods - Part 2: Tests of sterility performed in the
definition, validation and maintenance of a
sterilization process
1 Scope
This Part of GB/T 19973 specifies the general criteria for tests of sterility on
medical devices that have been exposed to a treatment with the sterilizing
agent 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.
This Part is not applicable to:
a) sterility testing for 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 11135-1, ISO 11137-1,
ISO 14160, ISO 14937 or ISO 17665-1.
c) culturing of biological indicators or inoculated products.
Note 2: Guidance on culturing biological indicators is included in ISO 14161.
2 Normative references
The following documents are indispensable for the application of this document.
For the dated references, only the editions with the dates indicated are
applicable to this document. For the undated references, the latest edition
(including all the amendments) are applicable to this document.
GB/T 19973.1-2015 Sterilization of medical devices - Microbiological
methods - Part 1: Determination of a population of microorganisms on
products (ISO 11737-1:2006, IDT)
GB/T 27025-2008 General requirements for the competence of testing and
calibration laboratories (ISO/IEC 17025:2005, IDT)
YY/T 0287-2003 Medical devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485:2003, IDT)
ISO 10012 Measurement management systems - Requirements for
measurement processes and measuring equipment
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 Aerobic organism
Microorganism that requires oxygen for metabolism.
3.2 Anaerobic organism
Microorganism that does not require oxygen for metabolism.
3.3 Bacteriostasis/fungistasis test
Technical operation performed with selected microorganisms to detect the
presence of substances that inhibit the multiplication of these microorganisms
in a test of sterility.
3.4 Bioburden
Population of viable microorganisms on a product and/or a package.
Note: Adapted from ISO/TS 11139:2006, definition 2.2.
3.5 Culture conditions
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.
[ISO/TS 11139:2006, definition 2.10]
3.6 Facultative organism
Microorganism capable of both aerobic and anaerobic metabolism.
3.7 Growth promotion test
Technical operation performed to demonstrate that a growth medium will
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.