Recognized Consensus Standards: Medical Devices

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

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

Michael Adjodha

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6276