CEN/TC 264 - |
Air quality |
Project
| Reference | EN 1422:2014 |
|---|---|
| Title | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| Work Item Number | 00102078 |
| Abstract/Scope | 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. |
| Status |
Published
|
| Reference Document | |
| date of Availability (DAV) | 2014-05-21 |
| ICS | 11.080.10 - Sterilizing equipment |
| A-Deviation(s) | |
| Special National Condition(s) |
Legal
| Directive(s) | 93/42/EEC |
|---|---|
| Mandate(s) | M/023 |
| Citation in OJEU | 93/42/EEC (No) |
Implementation Dates
| date of Ratification (DOR) (1) | 2014-04-17 |
|---|---|
| date of Availability (DAV) (2) | 2014-05-21 |
| date of Announcement (DOA) (3) | 2014-08-31 |
| date of Publication (DOP) (4) | 2014-11-30 |
| date of Withdrawal (DOW) (5) | 2017-05-30 |
Relations
| Supersedes | EN 1422:1997+A1:2009 |
|---|---|
| Normative reference (6) |
EN 13445-3
EN 13445-5 EN 14222 EN 61010-1:2010 EN 61010-2-040:2005
EN 61326-1:2006
EN 764-7
EN 868-4 EN 868-5 EN ISO 10993-7:2008 EN ISO 11135:2014 EN ISO 11138-1 EN ISO 11138-2 EN ISO 11607-1 EN ISO 14971:2012 EN ISO 3746:2010 |
| Sales Points |
|
(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
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