CEN/TC 264 - |
Air quality |
Project
| Reference | EN 13060:2014 |
|---|---|
| Title | Small steam sterilizers |
| Work Item Number | 00102115 |
| Abstract/Scope | This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids. This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm). The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971). This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases). This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat. NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665 1. This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide). |
| Status | |
| Reference Document | |
| date of Availability (DAV) | 2014-12-17 |
| 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 (C 226, 2015-07-10) |
Implementation Dates
| date of Ratification (DOR) (1) | 2014-11-15 |
|---|---|
| date of Availability (DAV) (2) | 2014-12-17 |
| date of Announcement (DOA) (3) | 2015-03-31 |
| date of Publication (DOP) (4) | 2015-06-30 |
| date of Withdrawal (DOW) (5) | 2015-12-31 |
Relations
| Supersedes | EN 13060:2004+A2:2010 |
|---|---|
| Normative reference (6) |
EN 10088-1
EN 1041+A1 EN 13060:2004+A2:2010
EN 13060:2014
EN 13445 series
EN 285:2006+A2:2009
EN 60529
EN 60751:2008 EN 61010-1:2010 EN 61010-2-040:2005
EN 61326-1:2013
EN 867-5:2001 EN 868 series EN ISO 11138-3 EN ISO 11140-1 EN ISO 14971:2012 EN ISO 17665-1:2006 EN ISO 228-1 EN ISO 3746 EN ISO 4017 EN ISO 4126-1 |
| Sales Points |
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(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.
We also invite you to check (via the website) whether corrigenda and/or amendments shall be read in conjunction with the main standard.