STN EN ISO 13485
| Name: | STN EN ISO 13485 |
| Validity: | Withdrawn |
| Number of pages: | 60 |
| Language: |
SK
|
| Paper: | 21,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
19,26€ b) Without ability to print, with ability to copy (printscreen) 21,40€ c) With ability to print and copy (printscreen) 27,82€ |
| Slovak title | Zdravotnícke pomôcky. Systémy manažérstva kvality. Požiadavky na splnenie predpisov (ISO 13485: 2003) |
| English title | Medical devices. Quality management systems. Requirements for regulatory purposes (ISO 13485:2003) |
| Release Date: | 01. 05. 2004 |
| Date of withdrawal: | 01. 10. 2012 |
| ICS: | 03.120.10, 11.040.01 |
| Sorting character/National clasification code | 85 5001 |
| Level of incorporation: | idt EN ISO 13485:2003, idt ISO 13485:2003 |
| Official Journal | 04/04 |
| Amendments | Oprava *AC V 11/07, Oprava *AC 2 V 01/10 |
| Replaced by: | STN EN ISO 13485:2012-10 (85 5001) |
| Repleces: | STN EN ISO 13485:2002-10 (85 5001), STN EN ISO 13488:2002-10 (85 5002), STN EN 46003:2001-10 (85 5004) |
| Note in Official Journal: | |
| Subject of the standard: | Táto medzinárod. norma stanovuje systém kvality manažérstva tam, kde organizácia potrebuje predviesť svoju schopnosť poskytovať zdravotnícke pomôcky a súvisiace služby. |