|Recognition List Number: 023 FR Publication Date: 05/05/2010
Part B: Supplementary Information
Recognition Number 3-63: ISO 11318:2002, cardiac defibrillators -- connector assembly df-1 for implantable defibrillators - dimensions and test requirements. (Cardiovascular)
Date of Standard: 2002.
|Address of Standards Development Organization:|
| 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:|
|OFFICE OF DEVICE EVALUATION (ODE) |
|DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
|Implantable Cardioverter Defibrillators|
|Processes Affected: |
|Type of Standard:|
| Vertical, International|
|Extent of Recognition:|
|Complete Standard except as noted below.
1. Specific requirement elements of this standard address dimensions, performance and electrical test requirements.
2. This standard specification is limited to the essential elements (described above) of a unipolar connector assembly, DF-1. It is intended for use in connecting implantable defibrillator leads to implantable defibrillator pulse generators which do not produce more than 1 kV/50 A peak output.
3. Essentially, the connector assembly consists of the "defibrillator lead connector" and "defibrillator connector cavity".
4. With respect to the "defibrillator lead connector", the standard defines the design requirements pertaining to sealing mechanism, dimensions, and marking. The associated test methods and requirements include the following: Insertion and Withdrawal Forces; Deformation due to Setscrew and Grip Zone Forces; and, Electrical Isolation Requirement.
5. With respect to the "defibrillator connector cavity", the standard defines the design requirements for dimensions but allows for optional seal mechanism. If seal(s) are provided, the standard specifies the Seal Location and Electrical Isolation Requirement. Other test requirements include Insertion and Withdrawal Forces and Current-Carrying Requirement.
6. This standard specifies that both the lead connector and the defibrillator generator shall be marked with the symbol "DF-1."
7. This standard incorporates Amendment 1.
EXCLUSION: The standard connector assembly, DF-1, does not include specifications of other connector features such as fastening means, materials, functional compatibility, reliability or interchangeability of different implantable defibrillator leads and implantable defibrillator generators assembled into an implantable defibrillator system.
|Related CFR Citations and Product Codes:|
||Defibrillator, Implantable, Dual-Chamber
||Implantable Cardioverter Defibrillator (Non-Crt)
|Relevant Guidance: |
|Guidance for Industry and FDA Reviewers on Implantable Cardioverter Defibrillators (Draft 4.8, April 16, 1999)|
|FDA Technical Contact:|
| Mitchell J. Shein |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1316 |
| Silver Spring MD 20993 |
| 301/796-6363 |
| email: email@example.com|
|* 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 |