Resumen
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
Preview
Previsualice esta norma en nuestra Plataforma de navegación en línea (OBP)
Informaciones generales
-
Estado: PublicadoFecha de publicación: 2019-02Etapa: Norma Internacional en proceso de revisión sistemática [90.20]
-
Edición: 2Número de páginas: 13
-
Comité Técnico :ISO/TC 198ICS :11.080.30
- RSS actualizaciones
Ciclo de vida
-
Anteriormente
RetiradaISO 11607-2:2006
RetiradaISO 11607-2:2006/Amd 1:2014
-
Ahora
-
00
Preliminar
-
10
Propuesta
-
20
Preparación
-
30
Comité
-
40
Consulta
-
50
Aprobación
-
60
Publicación
-
90
Revisión
-
95
Retirada
Correcciones / Modificaciones
PublicadoISO 11607-2:2019/Amd 1:2023
-
00
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)