Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-4: IEC 60601-2-16 (1998), Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment. (ObGyn/Gastroenterology)
Date of Standard: 1998. |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
|
SWITZERLAND
|
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
|
|
| Devices Affected: |
| Hemodialysis Systems, High Permeability Hemodialysis Systems |
|
| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.5820 |
System, Dialysate Delivery, Single Patient |
Class 2 |
FKP |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.5860 |
Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Class 2 |
KDI |
| |
|
| Relevant Guidance: |
Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA. Issued on August 30, 2002
Guidance for Industry and CDRH Reviewers-Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems. Issued August 7, 1998 |
|
| FDA Technical Contact: |
| Gema Gonzalez |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room G220 |
| Silver Spring MD 20993 |
| 301/796-6519 |
| Email: gema.gonzalez@fda.hhs.gov |
|
|
