References
- Directive 93/42/EEC.
- Directive 93/42/EEC Annex I.
- Directive 93/42/EEC Annex IX.
- 2.4/1 Guidelines for the Classifcation of Medical Devices.
- EN ISO 10993-1 Biological Assessment of Medical Products.
- EN ISO 14971 Medical Products — Application of a Risk Management to Medical Products.
- DIN EN 12006-3 Special Requirements Made on Cardiac and Vascular Implants,Part 3: Endovascular Implants.
- Medical Products Act,Article 19.
- DIN EN 12006-3,Annex B Animal Experiments with Stents.
- MEDDEV 2.7.1,Evaluation of Clinical Data: A Guide for Manufacturers and Notifed Bodies.
- DIN EN ISO 14155-1 Clinical Testing of Medical Products on Human Beings,General Requirements.
- DIN EN 556 Sterilization of Medical Products Labeled as STERILE.
- DIN EN 550 Sterilization of Medical Products — Validation and Routine Monitoring of Sterilization with Ethylene Oxide.
- DIN EN 552 Sterilization of Medical Products — Validation and Routine Monitoring of Sterilization by Irradiation.
- DIN EN 554 Sterilization of Medical Products — Validation and Routine Monitoring of Sterilization by Moist Heat.