Recognition List Number: 024 Publication Date: 06/10/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-227: AAMI / ANSI / IEC 60601-2-21:2009, Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers. (General Plastic Surgery/General Hospital)
Date of Standard: 2009. |
| Addresses of Standards Organizations: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
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| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
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| Processes Affected: |
| 510(k), PMA, PreIDE, IDE, HDE, GMP, Design Controls |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete Standard
Transition:
FDA recognition of ANSI/AAMI/IEC 60601-2-21 and the IEC 1996 Amendment 1:2000 - Medical electrical equipment Part 2: Particular requirements for safety of infant radiant warmers is hereby superseded by recognition of ANSI/AAMI/IEC 60601-2-21:2009 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers. FDA will accept declarations of conformity, in support of premarket submissions, to ANSI/AAMI/IEC 60601-1 until June 30, 2013. After this transitional period, declarations of conformity to Edition 2:2001 of the standard will not be accepted. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5130 |
Warmer, Infant Radiant |
Class 2 |
FMT |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Nancy Pressly |
| FDA/CDRH/OCD |
| 10903 New Hampshire Avenue Building 66, Room 5414 |
| Silver Spring MD 20993 |
| 301/796-5437 |
| Email: nancy.pressly@fda.hhs.gov |
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