ISO/DIS 23565

No disponible en español

En desarrollo

Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.

Reemplazará ISO/TS 23565:2021

ISO/DIS 23565

CHF 67

Convertir Franco suizo (CHF) a tu moneda

Resumen

This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables used in the manufacturing of cellular therapeutic products. This includes equipment for processing cellular therapeutic products starting from cell isolation/selection, expansion, washing, volume reduction, final formulation and preparation prior to cryopreservation for the storage of cellular therapeutic products.

This document provides guidance on the design, use and maintenance of equipment and equipment systems to both equipment suppliers and equipment users from aspects including the target parties, i.e. equipment supplier or equipment user, and phase of involved task, i.e. design, use or maintenance.

This document is applicable to any unit operation system that is used, alone or in combination, for the manufacturing of cellular therapeutic products, meeting equipment user requirements. It is applicable to equipment used for the purpose of monitoring equipment status.

It does not apply to:

processing equipment for cellular therapeutic products used at the point of care;
equipment used for analytical purposes;
biosafety cabinets, general cell culture equipment (such as CO₂ incubators, etc.), and software to control multiple equipment systems or multiple unit operations.

Informaciones generales

Estado
: En desarrollo

Puede contribuir al desarrollo del borrador de esta norma internacional. Para ello, contacte con su miembro nacional

Etapa
: Voto sobre el DIS iniciado: 12 semanas [40.20]
Edición
: 1

Número de páginas
: 28
Comité Técnico :
ISO/TC 276

ICS :
07.080
RSS actualizaciones