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Normas BSI – AENOR
19/30361785 DC

19/30361785 DC

BS EN ISO 13408-6. Aseptic processing of health care products. Part 6. Isolator systems

2019-04-17 /Definitive
Equivalencias internacionales:

ISO/DIS 13408-6


This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell based health care products.

This document does not specify requirements for restricted access barrier systems (RABS).

This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.

This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.

This International Standard does not define biosafety containment requirements.

Quality management, Verification, Clean rooms, Environment (working), Sterile equipment, Production, Quality assurance systems, Containers, Quality control, Personnel, Sterilization (hygiene), Medical equipment
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