I.S. EN 13975:2003
Current
The latest, up-to-date edition.
SAMPLING PROCEDURES USED FOR ACCEPTANCE TESTING OF IN VITRO DIAGNOSTIC MEDICAL DEVICES - STATISTICAL ASPECTS
Hardcopy , PDF
English
01-01-2003
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.
Dates of withdrawal of national standards are available from NSAI.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Procedures
Annex A (informative) General notes
Annex ZA (informative) Clauses of this European Standard
addressing requirements of EU Directives
Bibliography
Covers sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body.
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN 13975 : 2003 | Identical |
| EN 13975:2003 | Identical |
| BS EN 13975:2003 | Identical |
| DIN EN 13975:2003-11 | Identical |
| UNE-EN 13975:2003 | Identical |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.