YY/T 1265-2015 Evaluation of materials of medical device subject to moist heat 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 moist heat sterilization.
This standard is applicable to the evaluation of materials of medical devices subject to moist heat sterilization.
Note: 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 evaluation.
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 16886.1 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 expose any adverse health consequences
3.2
glass transition
reversible change of an amorphous polymer or a polymer having a partially crystalline state from a viscous or elastic state to a harder and more brittle state
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3.3
glass transition temperature
Tg
median value of the temperature range at which the glass transition occurs
3.4
melt temperature
Tm
melting temperature, or temperature at which the plastic melts
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 moist heat sterilization with specific materials
Bibliography
