CEN/TC 102/WG 6 - Gas sterilizers

This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories.
This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for:
- the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
- the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads.
This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012.
This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.
NOTE 1   For further information on safety, see examples in the Bibliography. National or regional regulations can exist.
This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.
NOTE 2   See EN ISO 14937.
This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively.
This European Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.
NOTE 3   For further information see ISO 10993 7.

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
This European Standard specifies minimum requirements:
- for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
- for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

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;
• for the equipment and controls of these sterilizers needed for operation, control and monitoring, and which can be used for validation of the sterilization processes;
• for the test equipment and test procedures used to verify the sterilizer performance specified by this document.
This document does not specify requirements for equipment 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.
This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.
NOTE 1 Attention is drawn to the standards for quality management, e.g. EN ISO 13485.
NOTE 2 Environmental aspects of this standard are addressed in Annex H.

1.1   This document specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
1.2   This document specifies minimum requirements:
-   for the performance and design of sterilizers intended to deliver an LTSF process capable of sterilizing medical devices;
-   for the equipment and controls of these sterilizers which are needed for operation, control and monitoring of the sterilization processes, and which can be used for validation of the sterilization process.
1.3   This document specifies further test equipment and test procedures used to verify conformance of the equipment design and performance specified by this document.
1.4   This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.

This European Standard 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 European Standard specifies minimum requirements
-   for the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;
-   for the equipment and controls of these sterilizers needed for operation, control and monitoring, and which can be used for validation of the sterilization processes;
-   for the test equipment and test procedures used to verify the sterilizer performance specified by this European Standard.
This European Standard does not specify requirements for equipment intended to process liquids, biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
This European Standard does not specify requirements and tests for decontamination systems for use in rooms, enclosures or environmental spaces.
NOTE 1   Attention is drawn to the standards for quality management, e.g. EN ISO 13485.
NOTE 2   Environmental aspects of this standard are addressed in Annex H.

2008-11-04 SJ: WI approved by BT + derogation from 4 year rule for amendments: BT C 64/2008.

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
This European Standard specifies minimum requirements:
-   for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
-               for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

1.1   This European standard specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas as the sterilant, either as a pure gas or in admixture with other gases (whether supplied ready mixed or mixed at the point of use) in a temporarily sealed chamber.
These sterilizers are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes. The two types of sterilizers have been designated Type A and Type B respectively using the following criteria:
-   Type A sterilizers are capable of being programmed by the user;
-   Type B sterilizers are of limited size and provided with one or more pre-set operating cycles which cannot be varied by the user.
The clauses of this standard apply to both types of sterilizer unless it is specifically indicated within the clause that it applies only to one of the types in particular.
1.2   This standard includes minimum performance and construction requirements for sterilizers working above or below atmospheric pressure:
-   To ensure that the process is capable of being used to sterilize medical products;
-   For the equipment and controls necessary to permit validation and monitoring of the sterilization process.
1.3   This standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in EN 550.
1.4   This standard does not specify the procedures and equipment which can be used to improve the efficacy and/or efficiency of the process before or after the sterilization cycle.
1.5   Considerations of operator safety are addressed in EN 61010-1: A2 and IEC 1010-2-042.
1.6   This standard is applicable when:
a)   Specified in a contract for supply of an ethylene oxide sterilizer;
or,
b)   A sterilizer manufacturer declares compliance when intending to supply an ethylene oxide st

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
This European Standard specifies minimum requirements:
-   for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
-   for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
This European Standard specifies minimum requirements:
¾ for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

This European standard specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas as the sterilant, either as a pure gas or in admixture with other gases (whether supplied ready mixed or mixed at the point of use) in a temporarily sealed chamber. These sterilizers are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes.

This European standard specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas as the sterilant, either as a pure gas or in admixture with other gases (whether supplied ready mixed or mixed at the point of use) in a temporarily sealed chamber. These sterilizers are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes.