About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
CEN/TC 204 |
- |
Sterilization of medical devices |
Project
| Reference | EN 556-2:2015 |
|---|---|
| Title | Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices |
| Work Item Number | 00204059 |
| Abstract/Scope | This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7. |
| Status |
Published
|
| Reference Document | |
| date of Availability (DAV) | 2015-09-02 |
| ICS | 11.080.01 - Sterilization and disinfection in general |
| A-Deviation(s) | |
| Special National Condition(s) |
Legal
| Directive(s) | 90/385/EEC, 93/42/EEC, 98/79/EC |
|---|---|
| Mandate(s) | M/252, M/BC/CEN/89/9 |
| Citation in OJEU | C 173 (2016-05-13) for Directive 90/385/EEC, C 173 (2016-05-13) for Directive 93/42/EEC, C 173 (2016-05-13) for Directive 98/79/EC |
Implementation Dates
| date of Ratification (DOR) (1) | 2015-07-24 |
|---|---|
| date of Availability (DAV) (2) | 2015-09-02 |
| date of Announcement (DOA) (3) | 2015-12-31 |
| date of Publication (DOP) (4) | 2016-03-31 |
| date of Withdrawal (DOW) (5) | 2016-03-31 |
Relations
| Supersedes | EN 556-2:2003 |
|---|---|
| Superseded by | FprEN 556-2 |
| Normative reference (6) |
EN ISO 11135:2014
EN ISO 11137-1:2015 EN ISO 13408-2:2011
EN ISO 13408-5:2011
EN ISO 13485:2012
EN ISO 14160:2011
EN ISO 14937:2009
EN ISO 17665-1:2006
EN ISO 20857:2013
EN ISO 25424:2011
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| 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.