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SSH 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)

May 6, 2014

General information

60.60     May 6, 2014

DPS

DPS/KT 316

European Norm

11.080.01  

English  

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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 directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Directive 98/79/EC
93/42/EEC

Medical devices

Directive 93/42/EEC
90/385/EEC

Active implantable medical devices

Directive 90/385/EEC

Life cycle

NOW

PUBLISHED
SSH EN ISO 20857:2013
60.60 Standard published
May 6, 2014

Related project

Adopted from EN ISO 20857:2013