Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-70: ASTM F 1246-91 (Reapproved 2005), Standard Specification for Electrically Powered Home Care Ventilators, Part 1 - Positive-Pressure Ventilators and Ventilator Circuits. (Anesthesias)
Date of Standard: 1991. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF COMPLIANCE (OC) | | |
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| (2) | OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB) | | DIVISION OF POSTMARKET SURVEILLANCE (DPS) |
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| (3) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Home Care Ventilators and Ventilator Circuits |
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| Processes Affected: |
| Design Control Inputs, Premarket Notification |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete and annexes with the following exceptions:
Clause 3.1.5 is recognized with clarification. The home environment refers only to the patient's place of residence outside the hospital, and not for transport or medical facility use.
Clause 4.1.1 is not recognized. Please refer to Section 5.3 of the Reviewer Guidance for Ventilators.
Clause 4.1.4 is recognized with clarification. Electrical safety, EMC and mechanical/environmental testing should be consistent with the recommendations of the Reviewer Guidance, Excerpts Related to EMI from November 1993 and the Draft Reviewer Guidance for Ventilators July 1995.
Clause 5.1.4 is not recognized
Clause 6.1.1 is not recognized. Please refer to Section 5.4 of the Reviewer Guidance for Ventilators. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5895 |
Continuous, Ventilator, Home Use |
Class 2 |
NOU |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5975 |
Set, Tubing And Support, Ventilator (W Harness) |
Class 1 |
BZO |
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| Relevant Guidance: |
Review Guidance for Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities, April 1996
Reviewer Guidance, Excerpts Related to Emi from November 1993
Draft Reviewer Guidance for Ventilators, July 1995
Guidance on Medical Device Labelling, April 2001 |
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| FDA Technical Contact: |
| Bahram Parvinian |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2534 |
| Silver Spring MD 20993 |
| 301/796-6445 |
| Email: bahram.parvinian@fda.hhs.gov |
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