|Recognition List Number: 021 FR Publication Date: 03/18/2009
Part B: Supplementary Information
Recognition Number 6-182: IEC 60601-2-38 1996/Amendment 1:1999, medical electrical equipment - part 2-38: particular requirements for the safety of electrically operated hospital beds. (General Plastic Surgery/General Hospital)
Date of Standard: 1996.
|Address of Standards Development Organization:|
| International Electrotechnical Commission (IEC)|
| 3, Rue de Varembe'|
| PO Box 131|
| CH-1211 Geneva 20, 0 |
|CDRH Office and Division associated with recognized standards:|
|OFFICE OF DEVICE EVALUATION (ODE) |
|Processes Affected: |
|510(k), PMA, IDE, PDP, HDE|
|Type of Standard:|
| International, Vertical|
|Extent of Recognition:|
|Complete standard with the following exceptions:|
Clause 23.101 is recognized in part. The FDA Guidance entitled "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment - Guidance for Industry and FDA Staff" issued March 10, 2006 should take precedence.
Table in Figure 114 is recognized in part.
The Designator D Dimension 235 mm is not recognized by FDA as it allows for chest entrapment. A 318 mm dimension is the proposed to replace the 235 mm dimension in the 2008 revised IEC standard. The FDA guidance does not make specific dimensional recommendations for Designator D.
Designator E Dimension 235 mm is not recognized by FDA as it allows for chest entrapment. A 318 mm dimension is the proposed to replace the 235 mm dimension in the 2008 revised IEC standard. At this time, the FDA guidance does not make specific dimensional recommendations for Designator E.
Designator F Dimension should include the test method for Entrapment Zone 4 in FDA hospital bed guidance.
|Related CFR Citations and Product Codes:|
||Bed, Ac-Powered Adjustable Hospital
|Relevant Guidance: |
|Guidance for Industry and FDA Staff Hospital Beds System Dimensional and Assessment Guidance to Reduce Entrapment Document issued on: March 10, 2006|
|FDA Technical Contact:|
| Joan Todd |
| FDA/CDRH/OSB |
| 10903 New Hampshire Avenue Building 66, Room 3118 |
| Silver Spring MD 20993 |
| 301/796-6079 |
| email: firstname.lastname@example.org|