Recognition List Number: 013 Publication Date: 10/31/2005
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 5-4: IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General)
Date of Standard: 1988. |
| Address of Standards Organization: |
| INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC) |
| 3, RUE DE VAREMBE' |
| P.O. BOX 131 |
| CH-1211 GENEVA 20, |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| ALL OFFICES AND DIVISIONS IN CDRH |
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| Devices Affected: |
All patient vicinity medical electrical equipment.
(by introducing this scope the types of equipment subject to the 300 micro-ampere leakage current requirement can be reduced as only equipment intended for use in the patient care vicinity need comply with then requirement.) |
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| Processes Affected: |
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| Type of Standard: |
| Horizontal, International |
| Extent of Recognition: |
Entire standard when applied with or modified by:
a. all applicable FDA recognized collateral standards,
b. all applicable FDA recognized particular standards,
c. all US National infrastructure requirements enacted as statute (e.g. NFPA 99, NFPA 70, National Electric Code, etc.) |
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| Related CFR Citations and Product Codes: |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Brian Fitzgerald |
| FDA/CDRH/OSEL |
| WO62, Room 4206 10903 New Hampshire Avenue |
| Silver Spring MD 20993 |
| 301/796-2579 |
| Email: brian.fitzgerald@fda.hhs.gov |
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