This International Standard specifies requirements and test methods for root canal sealants that cure with or without the aid of moisture and are used for permanent filling of the root canal with or without the aid of plug points. It can only be applied to sealants for orthograde use, i.e. a root filling placed from the coronal aspect of a tooth.
Certain qualitative and quantitative test methods are not included in this international standard to demonstrate independence from unacceptable biological risks, but it is recommended to refer to ISO 10993-1 and ISO 7405 for the assessment of such biological risks.
The components, when used in accordance with the manufacturer's instructions, will form a sealant that complies with the requirements of this international standard.
Specific qualitative and quantitative requirements for the determination of microbiological growth are not included in this international standard.
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