EN ISO 25539-3:2011
Current
The latest, up-to-date edition.
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
01-12-2011
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Intended performance
6 Design attributes
7 Materials
8 Design evaluation
9 Post-market surveillance
10 Manufacturing
11 Sterilization
12 Packaging
Annex A (informative) - Attributes of endovascular devices
- Vena cava filters - Technical and clinical
considerations
Annex B (informative) - Descriptions of potential device
effects of failure and failure modes and descriptions
of detrimental clinical effects
Annex C (informative) - Bench and analytical tests
Annex D (informative) - Test methods
Annex E (informative) - Examples of terms for clinical use
of vena cava filters
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
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.