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DIN Standards Committee Health Technologies

Abstract

This document specifies the requirements and tests for moist heat sterilizers intended to be used for the terminal sterilization of batch produced health care products presented as aqueous liquid in sealed containers. The aqueous liquid which the sterilizer is designed to process can be: — liquid water or solutions in which a solute is dissolved; — suspensions in which solid particles are suspended in an aqueous solvent; — oil in water emulsions in which oil droplets are suspended in an aqueous solvent. The container which the sterilizer is designed to process can be rigid, semi rigid, or flexible and constructed from, for example, glass or polymeric materials. The sterilizer is designed to operate with a moist heat heating medium introduced into or created within the chamber, which can consist of: — saturated steam; — non-saturated steam; — a mixture of steam and pressurized water spray; or — water immersion. This document applies to sterilizers designed to allow the load to remain static throughout the sterilization cycle and sterilizers that have a means by which the load is mechanically agitated by, for example, shaking or rotation. NOTE 1 The sterilizer can be used in a health care facility or an industrial setting. This document is intended for sterilizers which are designed to process a defined load of product and not for those which are designed to sterilize a continuous flow of product through a processing environment. This document is not intended to be retrospectively applied to pre-existing sterilizer equipment. NOTE 2 The sterilizing agent, moist heat, is produced within the contained product by use of a heating medium. NOTE 3 Sterilizers using saturated steam for sterilizing the surfaces of medical devices are covered by other standards, e.g. EN 285, EN 13060, ANSI/AAMI ST8, ANSI/AAMI ST55, JIS T 7322 and JIS T 7324. Some moist heat / steam sterilizers can be designed to provide both saturated steam sterilization processes and contained product sterilization processes.

Begin

2023-07-17

WI

00102180

Planned document number

DIN EN ISO 19253

Project number

17600029

Responsible national committee

NA 176-03-03 AA - Steam Sterilization/Disinfection apparatus  

Responsible european committee

CEN/TC 102/WG 5 - Steam sterilizers  

Responsible international committee

ISO/TC 198/WG 3 - Moist heat sterilization  

draft standard

Sterilization of health care products - Moist heat - Requirements for sterilizers used for the terminal sterilization of aqueous liquid in sealed containers (ISO/DIS 19253:2026); German and English version prEN ISO 19253:2026
2026-03
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