ISO 7551:2023
2023-05
Resumen
This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of 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.
Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.
Informaciones generales
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Estado: PublicadoFecha de publicación: 2023-05Etapa: Norma Internacional publicada [60.60]
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Edición: 2Número de páginas: 12
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Comité Técnico :ISO/TC 106/SC 1ICS :11.060.10
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Ciclo de vida
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Anteriormente
RetiradaISO 7551:1996
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Ahora
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00
Preliminar
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10
Propuesta
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20
Preparación
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30
Comité
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40
Consulta
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50
Aprobación
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60
Publicación
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90
Revisión
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95
Retirada
Modificaciones
Aportan contenido adicional; disponible para su compra; no incluidas en el texto de la norma existente.En desarrolloISO 7551:2023/CD Amd 1
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00
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