Abstract

This document specifies requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent. These sterilizers are used for the sterilization of medical devices, particularly thermolabile medical devices. This document specifies minimum requirements for: • the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices; • the equipment and controls of these sterilizers needed for operation, control and monitoring, and which can be used for validation of the sterilization processes; • the test equipment and test procedures used to verify the sterilizer performance specified by this document. This document does not specify requirements for sterilizer intended to process liquids, biological waste, or human tissues. This document does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE Attention is drawn to the standards for quality management, e.g. EN ISO 13485. This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.

Begin

2016-04-18

WI

00102158

Planned document number

DIN EN 17180

Project number

06301777

Responsible national committee

NA 176-03-04 AA - Low temperature sterilizers  

Responsible european committee

CEN/TC 102/WG 6 - Low temperature sterilizers  

draft standard

Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2017
2017-12
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Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023
2023-03
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Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2024
2024-12
Order from DIN Media