99.60 Withdrawal effective Nov 30, 2022
CEN
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
European Norm
11.080.10 Sterilizing equipment
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, Type B or Type S where ap-propriate. The test systems specified are intended for use only in small steam sterilizers Type B conforming to prEN 13060-2 and having a usable chamber space greater than 10 l and for small steam sterilizers Type S conforming to prEN 13060-4 also having a usable chamber space greater than 5 l.
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 EN 867-1.
- 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 prEN 13060-4;
- 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 EN 867-1.
The process challenge devices described in this standard are intended for use only in sterilizers of sufficient size to accommodate the proces
Legislation related to this standard
WITHDRAWN
EN 867-5:2001
99.60
Withdrawal effective
Nov 30, 2022
PUBLISHED
EN ISO 11140-6:2022