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SSH EN ISO 13408-2:2018

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

Dec 22, 2018

General information

60.60     Aug 8, 2018

DPS

DPS/KT 316

European Norm

11.080.01  

English  

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Scope

ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.
ISO 13408-2:2018 is not applicable to removal of viruses.
Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).
ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters.
ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

Related directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
98/79/EC

In vitro diagnostic medical devices

Harmonized

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 13408-2:2011

NOW

PUBLISHED
SSH EN ISO 13408-2:2018
60.60 Standard published
Aug 8, 2018

Related project

Adopted from EN ISO 13408-2:2018

Adopted from ISO 13408-2:2018