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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 3-112: AAMI / ANSI / ISO 7199:2009, cardiovascular implants and artificial organs - blood gas exchangers (oxygenators). (Cardiovascular)

Date of Standard: 2009. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Cardiopulmonary bypass oxygenators and integrated heat exchangers
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical, International
Extent of Recognition:
The complete ANSI/AAMI/ISO 7199:2009 standard and its Amendment 1 (issued 2012-02-15) with the following exceptions and qualifications:
(1) Section regarding the blood pathway integrity test procedure is not recognized because the specified test pressure of 40kPa is too low. An acceptable test procedure is described in the FDA Oxygenator Guidance (referenced below).

(2) Additional testing not included in this standard may be required for submissions to FDA/CDRH. For example, the FDA Oxygenator Guidance (referenced below) describes additional testing recommendations for 510(k) clearance, which are not specifically found in the Standard.

(3) For the tests that are described in this standard without acceptance criteria (e.g. the gas transfer, blood cell damage and heat exchanger performance testing), comparative tests with legally marketed devices may be necessary to establish the pass/fail criteria.
Related CFR Citations and Product Codes:
Device Name Device
§870.4350 Oxygenator, Cardiopulmonary Bypass Class 2 DTZ
Relevant Guidance:
Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff. Document issued on: November 13, 2000
FDA Technical Contacts:
 Catherine Wentz
  10903 New Hampshire Avenue WO66 RM1226
  Silver Spring MD 20993
  email: catherine.wentz@fda.hhs.gov
 Qijin Lu
  10903 New Hampshire Avenue WO62 RM2106
  Silver Spring MD 20993
  email: qijin.lu@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036