ISO 80601-2-61-2017 (2018) PDF

Full title and description

St ISO 80601-2-61:2017 (Corrected version Feb 2018) — "Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment". This particular standard specifies requirements that complement the general IEC/ISO 60601 series for the safe design, essential performance and testing of pulse oximeter monitors, pulse oximeter probes and probe cable extenders intended for use on humans (including home, clinical and emergency environments).

Abstract

ISO 80601-2-61:2017 addresses basic safety and essential performance of pulse oximeter equipment used to estimate arterial oxygen haemoglobin saturation (SpO2) and pulse rate. It applies to monitors, probes and probe cable extenders required for normal use and also covers reprocessed equipment. The document excludes devices intended solely for fetal use and oximeters that require blood sampling; it references the general standard IEC 60601-1 for clauses that remain applicable.

General information

• Status: Published (second edition).
• Publication date: 15 December 2017 (corrected version: February 2018).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment / diagnostic equipment).
• Edition / version: Edition 2 (2017), with a corrected version issued in Feb 2018.
• Number of pages: 90 (as listed in ISO catalogue for the 2nd edition).

Key bibliographic and status details taken from the ISO catalogue entry for ISO 80601-2-61:2017 (corrected 2018).

Scope

Applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, covering monitors, probes and probe cable extenders required for normal use. The standard covers devices used in professional healthcare, home healthcare and emergency medical services environments, and also applies to reprocessed pulse oximeter equipment. It does not apply to laboratory-research-only oximeters, oximeters that require blood sampling, or devices intended solely for fetal use. The standard is a particular standard in the IEC 60601 and ISO/IEC 80601 series and relies on IEC 60601-1 for general requirements.

Key topics and requirements

• Essential performance and accuracy requirements for SpO2 and pulse rate measurements, including validation and testing methods for sensors and monitors.
• Requirements covering pulse oximeter monitors, probes and probe cable extenders as a complete ME (medical electrical) system or as separate ME equipment.
• Risk-management and alarm/performance considerations tied to the intended use (clinical, home, EMS), and limits on applicability (e.g., not intended for fetal-only devices).
• Requirements and tests related to reprocessing (cleaning/sterilization) of probes and accessories where applicable.
• References and cross-references to IEC 60601-1 (general safety and essential performance for medical electrical equipment) for electrical, mechanical and environmental requirements.
• Provisions to support clinical validation across a range of subjects and conditions (regulatory expectations in several jurisdictions encourage robust clinical evidence, including diverse skin pigmentation and oxygenation ranges).

Summary of technical content and emphasis drawn from the standard's abstract and scope. Regulatory and clinical validation context noted by national regulators.

Typical use and users

Manufacturers and designers of pulse oximeters and probes; test laboratories performing compliance testing; regulatory specialists preparing declarations of conformity or 510(k)/regulatory submissions; clinical engineering and procurement teams in hospitals and EMS services; companies reprocessing or servicing probes. The standard is used to demonstrate design compliance for devices intended for clinical, home and emergency use.

Related standards

Commonly used in conjunction with IEC 60601-1 (general requirements for medical electrical equipment). Other related particular standards in the 80601/60601 family include ISO 80601-2-55 (respiratory gas monitors), ISO 80601-2-56 (clinical thermometers) and IEC/ISO documents addressing thermographs and other patient-monitoring equipment; the 2017 edition replaced the earlier ISO 80601-2-61:2011 edition.

Keywords

pulse oximeter; SpO2; pulse rate; medical electrical equipment; IEC 60601; essential performance; probes; reprocessing; clinical validation; home healthcare; emergency medical services.

FAQ

Q: What is this standard?

A: ISO 80601-2-61:2017 (Corr. Feb 2018) is the particular standard specifying basic safety and essential performance requirements for pulse oximeter equipment (monitors, probes and probe cable extenders) used on humans. It is the second edition and replaces the 2011 edition.

Q: What does it cover?

A: It covers technical requirements, tests and performance criteria for accurate SpO2 and pulse-rate measurement, probe and cable requirements, reprocessing aspects, intended-use declarations (clinical, home, EMS), and references to IEC 60601-1 for general safety and essential performance clauses. It excludes fetal-only oximeters and laboratory-only devices that require blood samples.

Q: Who typically uses it?

A: Medical device manufacturers, test labs, regulatory affairs professionals, clinical engineers, procurement and quality teams, and services that reprocess probes. Regulators and conformity-assessment bodies also use the standard as a technical benchmark.

Q: Is it current or superseded?

A: As of its publication it is the current (2nd) edition, published 15 December 2017 with a corrected version in February 2018; it supersedes ISO 80601-2-61:2011. National regulators periodically review recognition/applicability—some agencies (for example national standards-recognition listings) note specific clauses where recognition or application may be limited and encourage additional clinical evidence for certain accuracy claims. Users should check the latest national recognition lists and the ISO catalogue for revision status.

Q: Is it part of a series?

A: Yes — it is a "particular requirements" standard in the IEC/ISO 60601/80601 family of medical electrical equipment standards. It complements the general standard IEC 60601-1 (general requirements for basic safety and essential performance) and other Part 2 standards addressing specific monitoring and therapeutic equipment.

Q: What are the key keywords?

A: Pulse oximeter, SpO2 accuracy, pulse rate, probe, reprocessing, IEC 60601-1, essential performance, clinical validation, home healthcare, EMS.