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SRPS EN ISO 20857:2014

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)

Apr 30, 2014

General information

60.60     Apr 30, 2014

ISS

Z076

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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

Directive 90/385/EEC
93/42/EEC

Medical devices

Directive 93/42/EEC
98/79/EC

In vitro diagnostic medical devices

Directive 98/79/EC

Life cycle

NOW

PUBLISHED
SRPS EN ISO 20857:2014
60.60 Standard published
Apr 30, 2014

Related project

Adopted from EN ISO 20857:2013

Adopted from ISO 20857:2010 IDENTICAL