STN EN ISO 8637-1
| Name: | STN EN ISO 8637-1 |
| Validity: | Valid |
| Number of pages: | 34 |
| Language: |
EN
|
| Paper: | 17,20€ |
| Electronic version |
a) Only read (without ability to print and copy)
15,48€ b) Without ability to print, with ability to copy (printscreen) 17,20€ c) With ability to print and copy (printscreen) 22,36€ |
| Slovak title | Mimotelové systémy na čistenie krvi. Časť 1: Hemodialyzátory, hemodiafiltre, hemofiltre a hemokoncentrátory (ISO 8637-1: 2017) |
| English title | Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017) |
| Release Date: | 01. 07. 2020 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 6218 |
| Level of incorporation: | idt EN ISO 8637-1:2020, idt ISO 8637-1:2017 |
| Official Journal | 06/20 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 8637:2014-06 (85 6214) |
| Note in Official Journal: | |
| Subject of the standard: | ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans. ISO 8637-1:2017 does not apply to: - extracorporeal blood circuits; - plasmafilters; - haemoperfusion devices; - vascular access devices; - blood pumps; - pressure monitors for the extracorporeal blood circuit; - air detection devices; - systems to prepare, maintain or monitor dialysis fluid; - systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; - reprocessing procedures and equipment. NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2. |
| Preview: | Náhľad normy (PDF) |