I.S. EN 556-2:2015
Current
STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
Hardcopy , PDF
English
01-01-2015
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
National Foreword
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'.
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| 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 |
| BS EN 556-2:2015 | Identical |
| NS EN 556-2 : 2003 | Identical |
| NF EN 556-2 : 2015 | Identical |
| UNE-EN 556-2:2016 | Identical |
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