-50% de descuento* Si compras la misma norma UNE en distintos idiomas. * Dto. sobre el pvp inferior. Ver condiciones

DIN EN ISO 13408-7:2015-11

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015

Fecha edición: 2015-11-01
En Vigor
Idiomas disponibles: Inglés, Alemán
Resumen: This part of ISO 13408 specifies requirements and provides guidance on alternative approaches to processsimulations for the qualification of the aseptic processing of medical devices and combination products that cannotbe terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied. This part of ISO 13408 describes how risk assessment can be used during the development of an asepticprocess to design a process simulation study for medical devices and combination products in those caseswhere a straightforward substitution of media for product during aseptic processing is not feasible or would notsimulate the actual aseptic process.
Keywords: Aseptic|CE marking|Cleaning|Definitions|Health services|Medical devices|Medical instruments|Medical sciences|Medical technology|Quality assurance|Specification (approval)|Sterility
ICS: 11.080.01 - Esterilización y desinfeccion en general
CTN:

Equivalencia Internacional

Idéntica EN ISO 13408-7:2015

Idéntica ISO 13408-7:2012

Reemplazo Normas

Reemplaza a DIN EN ISO 13408-7:2015-03

El libro en palabras del autor

Ultricies magna feugiat malesuada sociosqu varius vivamus cubilia parturient, himenaeos vitae vehicula nam placerat netus urna platea, nostra rutrum felis mattis penatibus velit quisque.

Button
Preguntas frecuentes ¿Tienes alguna duda sobre nuestros productos?

Respuesta 2

Desde la web

Libros y normas

Más información