PREN 556-2 : DRAFT 2014
Superseded
View Superseded by
STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
12-01-2013
01-09-2015
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 |
TC 204
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| 14/30273161 DC : 0 | Identical |