Recognition List Number: 024 Publication Date: 06/10/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-63: IEC 60601-2-16 (Third edition - 2008), Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment CORRIGENDUM 1. (ObGyn/Gastroenterology)
Date of Standard: 2008. |
| Address of Standards Organization: |
| 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: |
| Hemodialysis Systems, High Permeability Hemodialysis Systems |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, GMP, Design Controls |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete Standard
Transition:
FDA recognition of IEC 60601-2-16 (1998) is hereby superseded by recognition of IEC 60601-2-16 (Third edition - 2008), Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment CORRIGENDUM 1. FDA will accept declaration of conformity, in support of premarket submissions, IEC 60601-2-16 (1998) until June 30, 2013. After this transitional period, declaration of conformity to IEC 60601-2-16 (1998) will not be accepted. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.5820 |
System, Dialysate Delivery, Single Patient |
Class 2 |
FKP |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.5860 |
Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Class 2 |
KDI |
| |
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| Relevant Guidance: |
Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA. Issued on August 30, 2002
Guidance for Industry and CDRH Reviewers-Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems. Issued August 7, 1998 |
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| FDA Technical Contact: |
| Gema Gonzalez |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room G220 |
| Silver Spring MD 20993 |
| 301/796-6519 |
| Email: gema.gonzalez@fda.hhs.gov |
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