Standards Development

Scope

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:

a) liquid water or solutions in which a solute is dissolved;

b) suspensions in which solid particles are suspended in an aqueous solvent;

c) 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:

1. saturated steam;

2. non-saturated steam;

3. a mixture of steam and pressurized water spray; or

4. water immersion.

An over pressurising non-condensable gas such as air or nitrogen introduced into the chamber can be used to prevent container deformation or bursting and protect the integrity of the container closure system for steam-air mixtures, heated water as a spray or water immersion processes.

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. 

The sterilizer can be used in a health care facility or an industrial setting.

The reference loads described in this document are representative of a small load of low thermal capacity and a large load of high thermal capacity which can be used for establishing the basic performance of the sterilizer. The performance of the sterilizer when processing production loads will be established during validation using specified loads. Requirements for the development, validation and routine control of moist heat sterilization processes is described in ISO 17665.

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.

Sterilizers conforming with this document can also be used for the sterilization of veterinary products.

Sterilizers conforming with this document can also be used for the sterilization of a contained product enclosed within a sterile barrier system conforming to the ISO 11607 series.

This document is not intended to be retrospectively applied to pre-existing sterilizer equipment.

NOTE 1 The sterilizing agent, moist heat, is produced within the contained product by use of a heating medium.

NOTE 2 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 fluid sterilization processes.