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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
01-04-1998
12-01-2013
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
Gives advice on the fundamental principles governing the biological evaluation of medical devices; and the selection of appropriate tests. Also helps with the definition of categories of devices based on the nature and duration of contact with the body. Also gives detailed definitions, tables and annexes.
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Superseded
|
| Standards | Relationship |
| DIN EN 30993-1:1994-12 | Identical |
| UNE-EN 30993-1:1994 | Identical |
| BS EN 30993-1:1994 | Identical |
| I.S. EN 30993-1:1995 | Identical |
| EN 30993-1 : 1994 | 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.