Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-86: ISO 8185 Third edition 2007-07-01, Corrected verions 2008-06-15 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems. (Anesthesias)
Date of Standard: 2011. |
| 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) | | |
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| Devices Affected: |
| Medical devices, including accessories (e.g. breathing tube, temperature sensors, etc.), which are intended to raise the water content of gases delivered to the patient in the form of water droplets or vapour, or both; excluding devices commonly referred to as ?room humidifiers? or humidifiers used in heating, ventilation, and air conditioning systems, or humidifiers incorporated into infant incubators. Nebulizers used for the delivery of drugs to patients are also excluded. |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Any declaration of conformance to ISO 8185 should be accompanied by the following documentation:
1. A summary report that identifies all sections of the standard with an indication of ?yes?, ?no?, or ?not applicable? to indicate conformance;
2. the tests reports accompanying those clauses of the standard that necessitate functional testing in order to verify compliance
3. the pass/fail acceptance criteria utilized
4. identification of and justification for any deviations from the requirements of the standard for application to the device under review
5. evidence of compliance with labeling (i.e. identification, marking and documents) requirements
Complete standard with the following exceptions:
Clause 4.6 is recognized in part. (cc) Delivered gas temperature, per the definition provided by clause 3.3 of ISO 8185:2007, shall be sampled at the patient connection port
Clause 6.1(aa) is recognized in part. Symbols included on the exterior of the humidifier should be accompanied by English Text.
Clause 6.8.2. is recognized in part. Please refer to the Draft Guidance for Industry and FDA staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling for recommendations regarding development of reuse instructions (e.g. cleaning process, and disinfection or sterilization method, as applicable) and appropriate validation methods.
Clause 6.8.2. is recognized in part. The Instructions for Use should specify the type of water (e.g. tap, distilled) for use with the humidifier device.
Clause 44.7 is not recognized. Please refer to the Draft Guidance for Industry and FDA staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling for recommendations regarding development of reuse instructions (e.g. cleaning process, and disinfection or sterilization method, as applicable) and appropriate validation methods.
Clause 44.8 Compatibility with substances used with the equipment is not recognized.
Clause 46 is not recognized. Please refer to FDA-recognized standard IEC 62366 Medical Devices ? Application of usability engineering to medical devices and Draft Guidance for Industry and FDA staff: Applying Human Factors and Usability Engineering to Optimize Device Design for processes and recommendations for integrating human factors engineering into product design and development, which ensures that needs of the user are appropriately defined, verified and validated.
Clause 102.1 is not recognized. Please refer to FDA-recognized standard IEC 62366 Medical Devices ? Application of usability engineering to medical devices and Draft Guidance for Industry and FDA staff: Applying Human Factors and Usability Engineering to Optimize Device Design for processes and recommendations for integrating human factors engineering into product design and development, which ensures that needs of the user are appropriately defined, verified and validated. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5270 |
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer |
Class 2 |
BZE |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5450 |
Humidifier, Respiratory Gas, (Direct Patient Interface) |
Class 2 |
BTT |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5895 |
Ventilator, Continuous, Facility Use |
Class 2 |
CBK |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5905 |
Ventilator, Non-Continuous (Respirator) |
Class 2 |
BZD |
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| Relevant Guidance: |
FDA Heated Humidifier Review Guide, 1997
Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, May 2011
Draft Guidance for Industry and FDA Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, June 2011
Draft Guidance for Industry and FDA Staff: 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, July 2011 |
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| FDA Technical Contact: |
| Paul Shin |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1253 |
| Silver Spring MD 20993 |
| 301/796-6667 |
| Email: paul.shin@fda.hhs.gov |
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| * 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 |
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