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EN ISO 20857:2013

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) EN ISO 20857:2013

Publication date:   Jun 14, 2013

General information

60.60 Standard published   Apr 17, 2013

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.
Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

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93/42/EEC

Medical devices

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90/385/EEC

Active implantable medical devices

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Life cycle

NOW

PUBLISHED
EN ISO 20857:2013
60.60 Standard published
Apr 17, 2013

Relations

Adopted from ISO 20857:2010 IDENTICAL