NBN EN 30993-1 : 1995
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
BIOLOGISCHE BEOORDELING VAN MEDISCHE HULPMIDDELEN - DEEL 1 : RICHTLIJNEN VOOR DE KEUZE VAN PROEVEN
04-01-1998
01-12-2013
Cooperating organizations
National foreword
Foreword
Introduction
Guide
1. Scope
2. Normative references
3. Definitions
4. General principles applying to biological evaluation
of materials and devices
5. Categorization of medical devices
6. Testing
7. Guidance on selection of biological evaluation tests
8. Assurance of test methods
Annexes
A. (informative) Rationale
B. (informative) Bibliography of international and
national standards and regulations
Tables
1. Guidance for initial evaluation tests
2. Guidance for supplementary evaluation tests
National annexes
NA. (informative) Committees responsible
NB. (informative) Cross-references
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.