Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-238: IEC 80601-2-35 Edition 2.0 2009-10, Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use. (General Plastic Surgery/General Hospital)
Date of Standard: 2009. |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
|
SWITZERLAND
|
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
|
| (2) | OFFICE OF COMPLIANCE (OC) |
|
| (3) | OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB) |
|
|
| Devices Affected: |
| All mattresses, heating blankets or pads for use with standard hospital beds for medical use |
|
| Processes Affected: |
| 510(k), PMA, IDE, PreIDE, HDE, GMP, Design Controls |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5100 |
Bed, Ac-Powered Adjustable Hospital |
Class 2 |
FNL |
| §880.5100 |
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use |
Class 2 |
LLI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5110 |
Bed, Hydraulic, Adjustable Hospital |
Class 1 |
FNK |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5120 |
Bed, Manual |
Class 1 |
FNJ |
| |
|
| Relevant Guidance: |
| FDA Guidance to Reduce Patient Entrapment would be replaced when this standard's transition period ends. (Note: Test methods for entrapment are not written for the layperson in the IEC standard) |
|
| FDA Technical Contact: |
| Gail Gantt |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2524 |
| Silver Spring MD 20993 |
| 301/796-6288 |
| Email: gail.gantt@fda.hhs.gov |
|
|
