| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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052
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Date of Entry 07/15/2019
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|
FR Recognition Number
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1-142
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| Standard | |
ISO 10079-1 Third Edition 2015-11-01
Medical suction equipment - Part 1: Electrically powered suction equipment [Including: Amendment 1 (2018)] |
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Scope/AbstractISO 10079-1:2015 specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field and transport use.
ISO 10079-1:2015 does not apply to the following:
a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors;
b) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
c) syringes;
d) dental suction equipment;
e) anaesthetic gas scavenging systems;
f) laboratory suction;
g) autotransfusion systems;
h) mucus extractors including neonatal mucus extractors;
i) suction equipment where the collection container is downstream of the vacuum pump;
j) ventouse (obstetric) equipment;
k) suction equipment marked for endoscopic use only;
l) plume evacuation systems. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized because it is scientifically and technically valid and not in conflict with existing regulatory policies. |
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Transition Period
| FDA recognition of ISO 10079-1 Third edition 2015-11 [Rec# 1-142] will be superseded by recognition of ISO 10079-1 Fourth edition 2022-03 [Rec# 1-157]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-142] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 1-142] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.5050 |
Apparatus, Suction, Patient Care
|
Class 2
|
DWM
|
| §870.5910 |
Esophageal Thermal Regulation And Gastric Suctioning Device
|
Class 2
|
PLA
|
| §874.5350 |
Device, Antichoke, Suction
|
Class 3
|
EWT
|
| §878.4780 |
Apparatus, Suction, Ward Use, Portable, Ac-Powered
|
Class 2
|
JCX
|
| §878.4780 |
Pump, Portable, Aspiration (Manual Or Powered)
|
Class 2
|
BTA
|
| §878.4780 |
Wound Drain Catheter System
|
Class 2
|
OTK
|
| §878.5040 |
System, Suction, Lipoplasty
|
Class 2
|
MUU
|
| §878.5040 |
System, Suction, Lipoplasty For Removal
|
Class 2
|
QPB
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Reviewers/Staff: Guidance Document for Powered Suction Pump 510(k)s, issued September 1998.
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 Contact
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| Standards Development Organization
|
| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
