What is BS EN 1422 - Requirements and test methods for ethylene oxide sterilizers about?
BS EN 1422 is a European standard that discusses ethylene oxide sterilizers for medical purposes. BS EN 1422 outlines 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 to ensure the proper sterilization of medical devices and their accessories.
BS EN 1422 outlines 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 shown in BS EN 1422 are selected to represent several loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads.
Note 1: BS EN 1422 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 before the release of the sterile product.
Note 2: BS EN 1422 does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities
Note 3: BS EN 1422 does not cover sterilizers that employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.
Who is BS EN 1422 - Requirements and test methods for ethylene oxide sterilizers for?
BS EN 1422 on requirements and test methods for ethylene oxide sterilizers for medical purposes is useful for:
- Manufacturers of ethylene oxide sterilizers
- Medical laboratories
- Regulatory authorities
Why should you use BS EN 1422 - Requirements and test methods for ethylene oxide sterilizers?
Ethylene oxide (EO) sterilizers employing EO gas as the sterilant, either as a pure gas or in admixture with other gases, are primarily used for the sterilization of heat-labile material or product.
BS EN 1422 guideline assists you with the technical requirements on risk control, usability, materials, sterilizer chamber, design, construction, indicating, measuring, and recording instruments for ethylene oxide sterilizers for medical purposes.
BS EN 1422 also guides on process control, performance requirements, sound power, packaging, marking, labelling, service, location environment, and information to be supplied by the manufacturer for ethylene oxide sterilizers for medical purposes.
With obedience and compliance to BS EN 1422, you can standardise the performance of ethylene oxide sterilizers for medical purposes and make them safe to use.
What’s changed since the last update?
BS EN 1422:2014 supersedes EN 1422:1997+A1:2009, which is withdrawn. BS EN 1422:2014 has made some technical changes compared to EN 1422:1997+A1:2009. These include:
- New specification of the scope of the standard, e.g., the explicit exclusion of sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber and removal of different types A and B of EO-sterilizers
- Normative references have been updated
- The layout of the standard brought in line with the standard for LTSF-sterilization (EN 14180)
- The additional requirements from the machinery directive, introduced by the revision of the medical device’s directive 2007/47/EC have been addressed (see revised Annex ZA), i.e., update of technical requirements and tables ZA.1 and ZA.2
- Requirements have been rephrased to be performance requirements instead of design requirements