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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 063 Date of Entry 12/23/2024 
FR Recognition Number 1-189
Standard
ISO  4135 Fourth edition 2022-01
Anaesthetic and respiratory equipment - Vocabulary
Scope/Abstract
This 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.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
866.6090 Cancer Predisposition Risk Assessment System Class 2 QAZ
§868.1870 Calibrator, Volume, Gas Class 1 BXW
§868.1965 Valve, Switching (Ploss) Class 1 JFE
§868.2300 Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge Class 1 CCN
§868.2350 Flowmeter, Calibration, Gas Class 1 BXY
§868.2875 Transducer, Gas Pressure, Differential Class 1 BYR
§868.5250 Circulator, Breathing-Circuit Class 2 CAG
§868.5270 Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Class 2 BZE
§868.5340 Cannula, Nasal, Oxygen Class 1 CAT
§868.5450 Humidifier, Respiratory Gas, (Direct Patient Interface) Class 2 BTT
§868.5450 Humidifier Nebulizer Kit Class 2 OGG
§868.5454 High Flow/High Velocity Humidified Oxygen Delivery Device Class 2 QAV
§868.5460 Humidifier, Non-Direct Patient Interface (Home-Use) Class 1 KFZ
§868.5630 Nebulizer (Direct Patient Interface) Class 2 CAF
§868.5630 Spacer, Direct Patient Interface Class 2 NVO
§868.5640 Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Class 1 CCQ
§868.5710 Tent, Pediatric Aerosol Class 2 FNC
§868.5760 Spreader, Cuff Class 1 CBG
§868.5795 Brush, Cleaning, Tracheal Tube Class 1 EPE
§868.5800 Tracheotomy Care Kit Class 2 NXA
§868.5895 Ventilator, Continuous, Facility Use Class 2 CBK
§868.5895 Ventilator, Continuous, Non-Life-Supporting Class 2 MNS
§868.5895 Ventilator, Continuous, Minimal Ventilatory Support, Facility Use Class 2 MNT
§868.5895 Accessory To Continuous Ventilator (Respirator) Class 2 MOD
§868.5895 Continuous, Ventilator, Home Use Class 2 NOU
§868.5895 Ventilator, Continuous, Minimal Ventilatory Support, Home Use Class 2 NQY
§868.5895 Mechanical Ventilator Class 2 ONZ
§868.5905 Ventilator, Non-Continuous (Respirator) Class 2 BZD
§868.5915 Ventilator, Emergency, Manual (Resuscitator) Class 2 BTM
§868.5915 Cardiopulmonary Resuscitation Aid Kit Class 2 OEV
§868.5925 Ventilator, Emergency, Powered (Resuscitator) Class 2 BTL
§868.5955 Attachment, Intermittent Mandatory Ventilation (Imv) Class 2 CBO
§868.6810 Catheters, Suction, Tracheobronchial Class 1 BSY
§870.2200 Adjunctive Heart Failure Status Indicator Class 2 QUO
§870.5050 Apparatus, Suction, Patient Care Class 2 DWM
§876.4680 Catheter, Suction, Tracheobronchial, Reprocessed Class 1 NQV
N/A Ventilator, High Frequency Class 3 LSZ
N/A Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led QKS
N/A Emergency Ventilator QOT
N/A Critical Care Ventilator QOV
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.
FDA Technical Contacts
 Neel Patel
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6274
  Neel.Patel@fda.hhs.gov
 Rachana Visaria
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  240-402-5628
  Rachana.Visaria@fda.hhs.gov
 Ethan Nyberg
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  240-402-5973
  Ethan.Nyberg@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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