Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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1-189
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Standard | |
ISO 4135 Fourth edition 2022-01 Anaesthetic and respiratory equipment - Vocabulary |
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Scope/AbstractThis document establishes a vocabulary of terms used for anaesthetic and respiratory equipment and supplies, related devices and supply systems.
NOTE 1 To avoid multiple definitions of the same term in different categories, this document attempts to ensure consistency by the inclusion of a 'general' category, and by use of domain specifiers and unique pre-coordinated domain-specific term names.
NOTE 2 In addition to terms and definitions used in two of the three official ISO languages (English and French), this document gives the equivalent terms in the German language; these are published under the responsibility of the member body for Germany. However, only the terms and definitions given in the official languages can be considered as ISO terms and definitions.
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
866.6090 |
Cancer Predisposition Risk Assessment System
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Class 2
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QAZ
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§868.1870 |
Calibrator, Volume, Gas
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Class 1
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BXW
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§868.1965 |
Valve, Switching (Ploss)
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Class 1
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JFE
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§868.2300 |
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
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Class 1
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CCN
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§868.2350 |
Flowmeter, Calibration, Gas
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Class 1
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BXY
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§868.2875 |
Transducer, Gas Pressure, Differential
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Class 1
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BYR
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§868.5250 |
Circulator, Breathing-Circuit
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Class 2
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CAG
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§868.5270 |
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
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Class 2
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BZE
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§868.5340 |
Cannula, Nasal, Oxygen
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Class 1
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CAT
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§868.5450 |
Humidifier, Respiratory Gas, (Direct Patient Interface)
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Class 2
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BTT
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§868.5450 |
Humidifier Nebulizer Kit
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Class 2
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OGG
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§868.5454 |
High Flow/High Velocity Humidified Oxygen Delivery Device
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Class 2
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QAV
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§868.5460 |
Humidifier, Non-Direct Patient Interface (Home-Use)
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Class 1
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KFZ
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§868.5630 |
Nebulizer (Direct Patient Interface)
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Class 2
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CAF
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§868.5630 |
Spacer, Direct Patient Interface
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Class 2
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NVO
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§868.5640 |
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
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Class 1
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CCQ
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§868.5710 |
Tent, Pediatric Aerosol
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Class 2
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FNC
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§868.5760 |
Spreader, Cuff
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Class 1
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CBG
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§868.5795 |
Brush, Cleaning, Tracheal Tube
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Class 1
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EPE
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§868.5800 |
Tracheotomy Care Kit
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Class 2
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NXA
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§868.5895 |
Ventilator, Continuous, Facility Use
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Class 2
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CBK
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§868.5895 |
Ventilator, Continuous, Non-Life-Supporting
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Class 2
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MNS
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§868.5895 |
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
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Class 2
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MNT
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§868.5895 |
Accessory To Continuous Ventilator (Respirator)
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Class 2
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MOD
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§868.5895 |
Continuous, Ventilator, Home Use
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Class 2
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NOU
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§868.5895 |
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
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Class 2
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NQY
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§868.5895 |
Mechanical Ventilator
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Class 2
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ONZ
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§868.5905 |
Ventilator, Non-Continuous (Respirator)
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Class 2
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BZD
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§868.5915 |
Ventilator, Emergency, Manual (Resuscitator)
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Class 2
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BTM
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§868.5915 |
Cardiopulmonary Resuscitation Aid Kit
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Class 2
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OEV
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§868.5925 |
Ventilator, Emergency, Powered (Resuscitator)
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Class 2
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BTL
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§868.5955 |
Attachment, Intermittent Mandatory Ventilation (Imv)
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Class 2
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CBO
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§868.6810 |
Catheters, Suction, Tracheobronchial
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Class 1
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BSY
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§870.2200 |
Adjunctive Heart Failure Status Indicator
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Class 2
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QUO
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§870.5050 |
Apparatus, Suction, Patient Care
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Class 2
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DWM
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§876.4680 |
Catheter, Suction, Tracheobronchial, Reprocessed
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Class 1
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NQV
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N/A |
Ventilator, High Frequency
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Class 3
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LSZ
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N/A |
Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led
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QKS
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N/A |
Emergency Ventilator
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QOT
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N/A |
Critical Care Ventilator
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QOV
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Relevant FDA Guidance and/or Supportive Publications*
1. Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, issued October 1993.
2. ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
3. ISO and IEC maintain terminology databases for use in standardization at the following addresses:
- ISO Online browsing platform: available at https://www.iso.org/obp
- IEC Electropedia: available at https://www.electropedia.org/
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |
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