STN EN ISO 14708-6
| Name: | STN EN ISO 14708-6 |
| Validity: | Valid |
| Number of pages: | 80 |
| Language: |
EN
|
| Paper: | 28,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
25,92€ b) Without ability to print, with ability to copy (printscreen) 28,80€ c) With ability to print and copy (printscreen) 37,44€ |
| Slovak title | Chirurgické implantáty. Aktívne implantovateľné zdravotnícke pomôcky. Časť 6: Osobitné požiadavky na aktívne implantovateľné zdravotnícke pomôcky určené na liečbu tachyarytmie (vrátane implantovateľných defibrilátorov) (ISO 14708-6: 2019) |
| English title | Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019) |
| Release Date: | 01. 10. 2022 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 3001 |
| Level of incorporation: | idt EN ISO 14708-6:2022, idt ISO 14708-6:2019 |
| Official Journal | 09/22 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies requirements that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance. This document was designed for tachyarrhythmia pulse generators used with either endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies. This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1). |
| Preview: | Náhľad normy (PDF) |