YY/T 1266-2015 Evaluation of materials of medical device subject to hydrogen peroxide sterilization
1 Scope
This standard specifies material selection, design and processing, and material test, and provides evaluation guidelines for the adaptability of materials selected for hydrogen peroxide sterilization.
This standard is applicable to the evaluation of materials of medical devices subject to hydrogen peroxide sterilization.
Note 1: The "hydrogen peroxide (H2O2) sterilization" specified in this standard refers to gaseous sterilization. Liquid hydrogen peroxide is also used for chemical sterilization, but this application is not within the scope of this standard.
Note 2: The content of this standard is general information and is intended to provide guidance for successful material qualification. This standard shall not be used as a justification for using materials without proper material qualification.
2 Normative references
The following referenced documents are indispensable for the application 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/T 1616 Hydrogen peroxide for industrial use
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY/T 0884-2013 Evaluation of materials of health care product subject to radiation sterilization
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
material biocompatibility
property of the constituent materials or packaging materials of a device not to produce substances harmful to human health after sterilization
3.2
surface modification
activity of causing changes in physical, chemical, or biological properties on the surface of a material
3.3
accelerated aging
process of storing medical devices at high temperatures or/and under other enhanced environmental conditions to simulate real time aging over a shorter period of time
3.4
shelf life
length of time that a product can be maintained without unacceptable effects on its functionality and biocompatibility under standardized storage conditions prior to use, or the length of time for which it is selected to fail
3.5
real time aging
process of storing medical devices under normal environmental conditions to evaluate their functional properties that change over time
4 Material selection
4.1 General
For medical devices subject to hydrogen peroxide sterilization, in order to ensure the safety and effectiveness of the products after hydrogen peroxide sterilization, the suitability of the product materials for hydrogen peroxide sterilization shall be evaluated.
Foreword I 1 Scope 2 Normative references 3 Terms and definitions 4 Material selection 5 Product design and processing 6 Material test Annex A (Informative) Compatibility of hydrogen peroxide sterilization with specific materials Bibliography
YY/T 1266-2015 Evaluation of materials of medical device subject to hydrogen peroxide sterilization
1 Scope
This standard specifies material selection, design and processing, and material test, and provides evaluation guidelines for the adaptability of materials selected for hydrogen peroxide sterilization.
This standard is applicable to the evaluation of materials of medical devices subject to hydrogen peroxide sterilization.
Note 1: The "hydrogen peroxide (H2O2) sterilization" specified in this standard refers to gaseous sterilization. Liquid hydrogen peroxide is also used for chemical sterilization, but this application is not within the scope of this standard.
Note 2: The content of this standard is general information and is intended to provide guidance for successful material qualification. This standard shall not be used as a justification for using materials without proper material qualification.
2 Normative references
The following referenced documents are indispensable for the application 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/T 1616 Hydrogen peroxide for industrial use
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY/T 0884-2013 Evaluation of materials of health care product subject to radiation sterilization
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
material biocompatibility
property of the constituent materials or packaging materials of a device not to produce substances harmful to human health after sterilization
3.2
surface modification
activity of causing changes in physical, chemical, or biological properties on the surface of a material
3.3
accelerated aging
process of storing medical devices at high temperatures or/and under other enhanced environmental conditions to simulate real time aging over a shorter period of time
3.4
shelf life
length of time that a product can be maintained without unacceptable effects on its functionality and biocompatibility under standardized storage conditions prior to use, or the length of time for which it is selected to fail
3.5
real time aging
process of storing medical devices under normal environmental conditions to evaluate their functional properties that change over time
4 Material selection
4.1 General
For medical devices subject to hydrogen peroxide sterilization, in order to ensure the safety and effectiveness of the products after hydrogen peroxide sterilization, the suitability of the product materials for hydrogen peroxide sterilization shall be evaluated.
Contents of YY/T 1266-2015
Foreword I
1 Scope
2 Normative references
3 Terms and definitions
4 Material selection
5 Product design and processing
6 Material test
Annex A (Informative) Compatibility of hydrogen peroxide sterilization with specific materials
Bibliography
