| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
|
050
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Date of Entry 09/17/2018
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|
FR Recognition Number
|
1-139
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| Standard | (Included in ASCA) |
ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
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Scope/AbstractISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed.
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.
ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.
If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.
Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 7.2.13 and 8.4.1 of the general standard. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Clause 201.12.1.101.1 SpO2 ACCURACY of PULSE OXIMETER EQUIPMENT, Specification is not recognized. |
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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 201.12.1.101.1 SpO2 ACCURACY of PULSE OXIMETER EQUIPMENT, Specification" is in conflict with an existing published final guidance. See Section 4.1 Accuracy of Pulse Oximeters, Table 3. Typical Arms Specification by Sensor Type, of the Guidance document cited below. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.2700 |
Oximeter
|
Class 2
|
DQA
|
|
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series
Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
