NEN-EN 12006-1
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes
inactive, Most Current
| Organization: | NEN |
| Publication Date: | 2 August 1999 |
| Status: | inactive |
| Page Count: | 55 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
Specifies particular requirements for heart valve substitutes. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. Specifies a number of test methods and requirements regarding the performance characteristics of equipment to be used to determine the physical, biological and chemical properties of heart valve substitutes of all types and of the materials and components of which they are made.
Document History
NEN-EN 12006-1
August 2, 1999
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes
Specifies particular requirements for heart valve substitutes. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing,...
September 1, 1995
Non active surgical implants - Particular reqirements for cardiac and vascular implants - Part 1: Heart valve substitutes
Specifies particular requirements for heart valve substitutes. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing,...