| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
060
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Date of Entry 05/29/2023
|
|
FR Recognition Number
|
4-306
|
| Standard | |
ISO 22052 First edition 2020-06
Dentistry - Compressed air source equipment |
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Identical AdoptionANSI ADA Standard No. 94-2021
Central Compressed Air Source Equipment |
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Scope/AbstractThis document specifies requirements and test methods for central compressed air source equipment supplying dental air for dental units and various dental air consuming devices in the dental office.
It also specifies quality requirements and test methods for the dental air produced by the central compressed air source equipment, such as requirements for the purity level of dental air.
It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the central compressed air source equipment.
This document applies only to central compressed air source equipment located outside of the dental treatment room.
This document does not apply to central compressed air source equipment located in the dental treatment room and facility piping. This document does not include requirements for dental laboratory applications (e.g. CAD/CAM systems). |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 5.1 Electrical Safety
Clause 5.2 Electromagnetic Compatibility |
|
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.
This standard is recognized in part because:
Clause 5.1 Electrical Safety is in conflict with another recognized standard, see Clause 1.1 Scope of ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] listed below.
Clause 5.2 Electromagnetc Compatibility is in conflict with another recognized standard, see Clause 1.1 Scope of IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests listed below.
Clause 5.2 is in conflict with an existing published final guidance, see Section IV.C.(1) Non-Implantable Medical Devices of the guidance listed below. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.4120 |
Saw, Bone, Ac-Powered
|
Class 2
|
DZH
|
| §872.4120 |
Drill, Bone, Powered
|
Class 2
|
DZI
|
| §872.4120 |
Driver, Wire, And Bone Drill, Manual
|
Class 2
|
DZJ
|
| §872.4120 |
Handpiece, Rotary Bone Cutting
|
Class 2
|
KMW
|
| §872.4200 |
Controller, Foot, Handpiece And Cord
|
Class 1
|
EBW
|
| §872.4200 |
Handpiece, Belt And/Or Gear Driven, Dental
|
Class 1
|
EFA
|
| §872.4200 |
Handpiece, Air-Powered, Dental
|
Class 1
|
EFB
|
| §872.4200 |
Handpiece, Contra- And Right-Angle Attachment, Dental
|
Class 1
|
EGS
|
| §872.4200 |
Handpiece, Direct Drive, Ac-Powered
|
Class 1
|
EKX
|
| §872.4200 |
Handpiece, Water-Powered
|
Class 1
|
EKY
|
| §872.4200 |
Handpiece, Air-Powered, Root Canal Irrigation
|
Class 1
|
NYL
|
| §872.4565 |
Unit, Syringe, Air And/Or Water
|
Class 1
|
ECB
|
| §872.4840 |
Scaler, Rotary
|
Class 2
|
ELB
|
| §872.6080 |
Airbrush
|
Class 2
|
KOJ
|
| §872.6640 |
Mouthpiece, Saliva Ejector
|
Class 1
|
DYN
|
| §872.6640 |
Unit, Suction Operatory
|
Class 1
|
EBR
|
| §872.6640 |
Evacuator, Oral Cavity
|
Class 1
|
EHZ
|
| §872.6640 |
Unit, Operative Dental
|
Class 1
|
EIA
|
| §872.6640 |
Unit, Operative Dental, Accessories
|
Class 1
|
NRD
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff, issued June 2022.
2. ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021].
3. IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
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