EN 556-2:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
02-09-2015
31-03-2016
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 90/385/EEC on
active implantable medical devices
Annex ZB (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC on
medical devices
Annex ZC (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 98/79/EC on in
vitro diagnostic medical devices
Bibliography
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.NOTEFor 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.
| Committee |
CEN/TC 204
|
| DevelopmentNote |
Supersedes PREN 556-2. (09/2015)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| NBN EN 556-2 : 2015 | Identical |
| PN EN 556-2 : 2015 | Identical |
| DIN EN 556-2:2015-11 | Identical |
| NEN EN 556-2 : 2015 | Identical |
| SS-EN 556-2:2015 | Identical |
| BS EN 556-2:2015 | Identical |
| NS EN 556-2 : 2003 | Identical |
| NF EN 556-2 : 2015 | Identical |
| I.S. EN 556-2:2015 | Identical |
| DS EN 556-2 : 2015 | Identical |
| UNE-EN 556-2:2016 | Identical |