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Dentistry — Endodontic absorbent points
Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations can be made.
Reference is made to internationally accepted pharmacopoeia.
NOTE 2 National requirements can apply.
StandardDetails on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.
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