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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 060 Date of Entry 05/29/2023 
FR Recognition Number 4-305
Standard
ISO  10637 Second edition 2018-05
Dentistry - Central suction source equipment
Identical Adoption
ANSI ADA Standard No. 177-2020
Central Suction Source Equipment
Scope/Abstract
This document specifies requirements and test methods for stationary, electrically powered central suction source equipment, including centrally located amalgam separators and air water separators.

It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the central suction source equipment as part of the complete dental suction system.

This document specifies requirements for central suction source equipment used to provide vacuum pressure and flow at the facility pipeline connection point.

This document does not apply to portable suction source equipment, air/water venturi suction source equipment, or to suction source equipment located in the treatment room. It also does not apply to suction source equipment used for life support or for scavenging halogenated anaesthetic gases.

This document does not include requirements for facility and exhaust piping systems or treatment room equipment.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 5.3 Electrical Safety
Clause 5.4 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 5.3 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 5.4 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 5.4 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
§872.4200 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
§872.4565 Unit, Syringe, Air And/Or Water Class 1 ECB
§872.4840 Scaler, Rotary Class 2 ELB
§872.6080 Airbrush Class 2 KOJ
§872.6250 Chair, Dental, With Operative Unit Class 1 KLC
§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
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  lauren.giles@fda.hhs.gov
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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