BS EN 867-5:2001

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Marking, labelling and packaging
Annex A (normative) Small steam exposure apparatus and steam
        for test purposes
Annex B (normative) Test cycles for evaluation of indicator
        performance in the porous load process challenge
        devices
Annex C (normative) Test cycles for evaluation of indicator
        systems for use in hollow load process challenge
        devices
Bibliography

Describes the performance requirements and test methods for non-biological indicator systems, including the process challenge devices within which they are intended to function, to be used for testing the steam penetration performance of small steam sterilizers, Type B of Type S where appropriate.

This European Standard specifies the performance requirements and test methods for non-biological indicator systems, including the process challenge devices within which they are intended to function, to be used for testing the steam penetration performance of small steam sterilizers, TypeB or TypeS where appropriate. The test systems specified are intended for use only in small steam sterilizers TypeB conforming to prEN13060-2 and having a usable chamber space greater than 10l and for small steam sterilizers TypeS conforming to prEN13060-4 also having a usable chamber space greater than 5l.

Non-biological indicator systems and the associate process challenge devices are specified for various types of load. The possible loads are considered in two classes: Porous loads, which can be wrapped or unwrapped, or hollow instrument loads, which also can be wrapped or unwrapped.

The relevant section of this European Standard on porous loads specifies the requirements for:

• a standard process challenge device to be used in the small load test for porous loads in small steam sterilizers;

• an indicator system for use in the porous load process challenge device. An indicator for this purpose is a Class B indicator as described in EN867-1.

• an indicator employing an alternative process challenge device equivalent to the porous load process challenge device.

The relevant section of this European Standard on hollow instruments specifies the requirements for:

• hollow load process challenge devices to be used to simulate hollow instrument loads as defined in prEN13060-4;

• an indicator system, for use in one of the hollow load process challenge device, for assessing steam penetration in a wrapped load of hollow instruments. An indicator for this purpose is a Class B indicator as described in EN867-1.

The process challenge devices described in this standard are intended for use only in sterilizers of sufficient size to accommodate the process challenge device with no part of the process challenge device closer than 20mm from the vessel wall; in the case of the porous load process challenge device the total internal volume of the vessel is not less than 10l.