Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-74: ISO 13958 Second edition 2009-04-15, Concentrates for haemodialysis and related therapies. (ObGyn/Gastroenterology)
Date of Standard: 2009. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| 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) | | DIVISION OF REPRODUCTIVE, GASTRORENAL AND UROLOGY DEVICES (DRGUD) |
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| Devices Affected: |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Quality System Regulations |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
ISO 13958:2009 Concentrates for hemodialysis and related therapies;
With the following qualifications:
Additional testing not included in this standard may be required for marketing clearance or approval.
In general, the standard may be applied as needed to dry cartridges.
For 510(k) devices, testing and design requirements specified in Sections 4 and 5 should be applied in terms of comparing predicate and proposed devices and determining substantial equivalence.
For Section 5.2.10 Containers, compliance with 4.1.10 may be determined by testing in accordance with FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
For Section 5.4.2 Materials compatibility, compliance with the requirements of 4.3.2 can be determined by testing in accordance with FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.5820 |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
Class 2 |
KPO |
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| Relevant Guidance: |
Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis. Issued May 30, 1997.
Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA. Issued August 30, 2002. |
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| FDA Technical Contact: |
| Jeffrey Cooper, D.V.M. |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room G228 |
| Silver Spring MD 20993 |
| 301/796-5590 |
| Email: jeffrey.cooper@fda.hhs.gov |
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