STN EN ISO 13485
| Name: | STN EN ISO 13485 |
| Validity: | Withdrawn |
| Number of pages: | 16 |
| Language: |
SK
|
| Paper: | 14,10€ |
| Electronic version |
a) Only read (without ability to print and copy)
12,69€ b) Without ability to print, with ability to copy (printscreen) 14,10€ c) With ability to print and copy (printscreen) 18,33€ |
| Slovak title | Systémy kvality. Zdravotnícke pomôcky. Osobitné požiadavky na používanie EN ISO 9001 (ISO 13485:1996) |
| English title | Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001 (identical to ISO 13485:1996) |
| Release Date: | 01. 10. 2002 |
| Date of withdrawal: | 01. 05. 2004 |
| ICS: | 03.120, 11.040.01 |
| Sorting character/National clasification code | 85 5001 |
| Level of incorporation: | idt ISO 13485:1996, idt EN ISO 13485:2000 |
| Official Journal | 09/02 |
| Amendments | |
| Replaced by: | STN EN ISO 13485:2004-05 (85 5001) |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | Spolu s ISO 9001 táto norma špecifikuje požiadavky systému kvality na návrh/vývoj, výrobu a ak treba na zavedenie do prevádzky a na obsluhu zdravotníckych pomôcok. |