ISO 20857:2010
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of an industrial sterilization process for medical devices
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.
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.
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- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.
The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.
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