Recognition List Number: 024 Publication Date: 06/10/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-231: AAMI / ANSI / IEC 60601-2-20:2009, Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators. (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, IDE, PreIDE, HDE, GMP, Design Controls |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete Standard
Transition:
FDA recognition of IEC 60601-2-20 1996-10: Amendment 1 - Medical electrical equipment Part 2: Particular requirements for the safety of transport incubators is hereby superseded by recognition of ANSI/AAMI/IEC 60601-2-20:2009 Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant incubators. FDA will accept declaration of conformity, in support of premarket submissions, to IEC 60601-2-20:1996 until June 30, 2013. After this transitional period, declaration of conformity to IEC 60601-2-20:1996 will not be accepted. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5410 |
Incubator, Neonatal Transport |
Class 2 |
FPL |
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| Relevant Guidance: |
| Guidance for Industry and FDA Reviewers/Staff Neonatal and Neonatal Transport Incubators - Premarket Notifications Documents issued on: September 18, 1998 |
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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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