BS EN 556-2:2015
Superseded
View Superseded by
Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices
Hardcopy , PDF
English
30-09-2015
08-11-2024
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
Describes the requirements for an aseptically processed medical device to be designated 'STERILE'.
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes 02/560165 DC (02/2004) Supersedes 14/30273161 DC. (09/2015)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| Standards | Relationship |
| NBN EN 556-2 : 2015 | Identical |
| EN 556-2:2015 | Identical |
| DIN EN 556-2:2015-11 | Identical |
| NEN EN 556-2 : 2015 | Identical |
| NS EN 556-2 : 2003 | Identical |
| NF EN 556-2 : 2015 | Identical |
| I.S. EN 556-2:2015 | Identical |
| UNE-EN 556-2:2016 | Identical |
A newer version of this standard is available.
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