Recognition List Number: 022 Publication Date: 09/08/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 5-49: IEC 60601-1-8 Ed. 1, Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: Alarm Systems - Requirements, tests and guidances - General requirements and guidelines for alarm systems in medical equipment. (General)
Date of Standard: 2003. |
| 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: |
|
|
| Devices Affected: |
|
| Processes Affected: |
| 510(k), IDE, PMA, PDP, HDE, QSR, Design Controls |
|
| Type of Standard: |
| Horizontal, International |
| Extent of Recognition: |
| Complete standard and any annexes |
|
| Related CFR Citations and Product Codes: |
|
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Ron D. Kaye |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2520 |
| Silver Spring MD 20993 |
| 301/796-6289 |
| Email: ron.kaye@fda.hhs.gov |
|
|
