GB 18278.1-2015 Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices (English Version)
Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
1 Scope
This part of GB 18278 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
Note: Although the scope of this part is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.
Moist heat sterilization processes covered by this part include but are not limited to:
a) saturated steam venting systems;
b) saturated steam active air removal systems;
c) air steam mixtures;
d) water spray;
e) water immersion.
Note: See Annex E.
This part of GB 18278 does not specify requirements for development, validation, and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
Note: See YY/T 0771.1, YY/T 0771.2 and ISO 22442-3.
This part of GB 18278 does not apply to those sterilization processes that are based on a combination of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent.
This part of GB 18278 does not detail a specified requirement for designating a medical device as “sterile.”
Note: Attention is drawn to national or regional requirements for designating medical devices as “sterile.” See, for example, YY/T 0615.1 or ANSI/AAMI ST67.
This part of GB 18278 does not specify a quality management system for the control of all stages of production of medical devices.
Note: It is not a requirement of this part of GB 18278 to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party.
This part of GB 18278 does not specify requirements for occupational safety associated with the design and operation of moist heat sterilization facilities.
Note: Requirements for operational safety are specified in GB4793.4. Additionally, safety regulations exist in some countries.
2 Normative references
The following documents contain provisions 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.
ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General Requirements
ISO 11138-3 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 11140-3 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test
ISO 11140-4 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
ISO 11140-5 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
ISO 13485: 2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 17664 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
air detector
device designed to detect the presence of non-condensable gases in a stream of steam and condensate or in the sterilizer chamber
3.2
automatic controller
device that, in response to pre-determined operating cycle variables, operates the sterilizer sequentially through the required stages of the operating cycle(s)
3.3
bioburden
population of viable microorganisms on and/or in a product and/or sterile barrier system [GB/T 19971-2015, definition 2.2]
3.4
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
[GB/T 19971-2015, definition 2.3]
3.5
calibration
set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards. Its purpose is to determine the indication value of the measuring instrument by comparison with the standard
[VIM: 1993, definition 6.11]
3.6
chemical indicator (non-biological indicator)
test system that reveals change in one or more pre-defined process variables based on a chemical or physical change resulting from exposure to a process [GB/T 19971-2015, definition 2.6]
3.7
contained product
product for which the environment within the sterilizer during any stage of the sterilization process does not come into direct contact with the product
Note: The environment within the sterilizer is used for heating and cooling purposes only, not for achieving the sterilization effect; e.g. a solution in a sealed bottle.
3.8
correction
action to eliminate a detected nonconformity
Note 1: A correction may be made in conjunction with a corrective action.
Note 2: A correction may be, for example, rework or degrade.
[GB/T 19000-2008, definition 3.6.6]
Contents
Foreword i
Introduction iv
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (Informative) Guidance
Annex B (informative) Process definition based on inactivation of the microbial population in its natural state (bioburden-based method)
Annex C (Informative) Process definition based on the inactivation of a reference microorganism and a knowledge of bioburden on product items to be sterilized (combined bioburden/biological indicator based method)
Annex D (Informative) Conservative process definition based on inactivation of reference microorganisms (overkill method)
Annex E (Informative) Operating cycles
Bibliography
GB 18278.1-2015 Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices (English Version)
Standard No.
GB 18278.1-2015
Status
valid
Language
English
File Format
PDF
Word Count
18500 words
Price(USD)
140.0
Implemented on
2017-1-1
Delivery
via email in 1 business day
Detail of GB 18278.1-2015
Standard No.
GB 18278.1-2015
English Name
Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
1 Scope
This part of GB 18278 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
Note: Although the scope of this part is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.
Moist heat sterilization processes covered by this part include but are not limited to:
a) saturated steam venting systems;
b) saturated steam active air removal systems;
c) air steam mixtures;
d) water spray;
e) water immersion.
Note: See Annex E.
This part of GB 18278 does not specify requirements for development, validation, and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
Note: See YY/T 0771.1, YY/T 0771.2 and ISO 22442-3.
This part of GB 18278 does not apply to those sterilization processes that are based on a combination of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent.
This part of GB 18278 does not detail a specified requirement for designating a medical device as “sterile.”
Note: Attention is drawn to national or regional requirements for designating medical devices as “sterile.” See, for example, YY/T 0615.1 or ANSI/AAMI ST67.
This part of GB 18278 does not specify a quality management system for the control of all stages of production of medical devices.
Note: It is not a requirement of this part of GB 18278 to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party.
This part of GB 18278 does not specify requirements for occupational safety associated with the design and operation of moist heat sterilization facilities.
Note: Requirements for operational safety are specified in GB4793.4. Additionally, safety regulations exist in some countries.
2 Normative references
The following documents contain provisions 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.
ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General Requirements
ISO 11138-3 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 11140-3 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test
ISO 11140-4 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
ISO 11140-5 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
ISO 13485: 2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 17664 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
air detector
device designed to detect the presence of non-condensable gases in a stream of steam and condensate or in the sterilizer chamber
3.2
automatic controller
device that, in response to pre-determined operating cycle variables, operates the sterilizer sequentially through the required stages of the operating cycle(s)
3.3
bioburden
population of viable microorganisms on and/or in a product and/or sterile barrier system [GB/T 19971-2015, definition 2.2]
3.4
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
[GB/T 19971-2015, definition 2.3]
3.5
calibration
set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards. Its purpose is to determine the indication value of the measuring instrument by comparison with the standard
[VIM: 1993, definition 6.11]
3.6
chemical indicator (non-biological indicator)
test system that reveals change in one or more pre-defined process variables based on a chemical or physical change resulting from exposure to a process [GB/T 19971-2015, definition 2.6]
3.7
contained product
product for which the environment within the sterilizer during any stage of the sterilization process does not come into direct contact with the product
Note: The environment within the sterilizer is used for heating and cooling purposes only, not for achieving the sterilization effect; e.g. a solution in a sealed bottle.
3.8
correction
action to eliminate a detected nonconformity
Note 1: A correction may be made in conjunction with a corrective action.
Note 2: A correction may be, for example, rework or degrade.
[GB/T 19000-2008, definition 3.6.6]
Contents of GB 18278.1-2015
Contents
Foreword i
Introduction iv
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (Informative) Guidance
Annex B (informative) Process definition based on inactivation of the microbial population in its natural state (bioburden-based method)
Annex C (Informative) Process definition based on the inactivation of a reference microorganism and a knowledge of bioburden on product items to be sterilized (combined bioburden/biological indicator based method)
Annex D (Informative) Conservative process definition based on inactivation of reference microorganisms (overkill method)
Annex E (Informative) Operating cycles
Bibliography
