ISO 80601-2-69:2014 PDF

Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

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Title (English):

ISO 80601-2-69:2014

Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 46
Publication date:: May 12, 2014
Edition:: IEC IS 80601 edition 1 version 1
ICS:: 11.040.10

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Description (English):

ISO 80601-2-69:2014 specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment, including transit-operable use by a single patient in various environments including any private and public transportation as well as in commercial aircraft. ISO 80601-2-69:2014 is applicable to a transit-operable and non-transit-operable oxygen concentrator. It is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.

Technical details

Technical committee: SC 62D - Particular medical equipment, software, and systems
SKU: ISO 80601-2-69:2014

Abstract

Overview

ISO 80601-2-69:2014 - Medical electrical equipment - Particular requirements for basic safety and essential performance of oxygen concentrator equipment - is a particular standard in the IEC/ISO 60601 series. It specifies safety and essential-performance requirements for oxygen concentrators and their accessories, intended to increase the oxygen concentration of gas delivered to a single patient. The scope explicitly covers both transit‑operable and non‑transit‑operable concentrators for the home healthcare environment (including public and private transport and commercial aircraft) and devices integrated into other ME equipment or systems.

Keywords: ISO 80601-2-69:2014, oxygen concentrator standard, medical electrical equipment, basic safety, essential performance, home healthcare, transit-operable.

Key topics and technical requirements

ISO 80601-2-69:2014 builds on the general IEC 60601-1 framework and adds particular requirements that reflect the unique risks of oxygen concentrators. Major technical topics include:

Scope and definitions specific to oxygen concentrators and accessories.
Identification, marking and documentation requirements (labelling, symbols and user information).
Protection against electrical and mechanical hazards, excessive temperature, unwanted radiation and contamination of breathing gas pathways.
Accuracy of controls and instruments, and protection against hazardous outputs (including oxygen delivery performance tests).
Hazardous situations and fault conditions testing, plus requirements for Programmable Electrical Medical Systems (PEMS).
Construction and ME system integration, including EMC (electromagnetic compatibility) considerations.
Accessories and interfaces: outlet connectors, signal input/output parts, remote-control and distributed alarm connections.
Infection control: requirements and tests for cleaning and disinfection procedures.
Fire risk mitigation: measures and tests to prevent propagation of fire into the concentrator and its accessories.
Performance characteristics: the standard recognises typical oxygen concentrations produced by concentrators (commonly ~82–96%, product gas up to ~95%) and requires validation of delivery performance.

Practical applications

This standard is applied to:

Design and development of home and portable oxygen concentrators.
Test protocols for verifying oxygen delivery, safety, EMC, cleaning/disinfection and fire resistance.
Selection and certification of accessories (tubing, conserving equipment, humidifiers, outlet connectors).
Integration of concentrators into larger ME systems (e.g., anaesthesia setups, filling systems).

Who uses this standard

Medical device manufacturers and designers of oxygen concentrators and accessories.
Certification and testing laboratories conducting safety and performance evaluations.
Regulatory authorities and conformity assessment bodies.
Biomedical engineers, procurement specialists and hospital/homecare teams assessing device compliance.

Related standards

IEC/ISO 60601-1 (general medical electrical safety)
IEC 60601-1-11 (home healthcare environment)
IEC 60601-1-2 (electromagnetic compatibility) and other collateral standards referenced within ISO 80601-2-69.

Related standards

Standards mentioned in the description

Abstract

Overview

Keywords: ISO 80601-2-69:2014, oxygen concentrator standard, medical electrical equipment, basic safety, essential performance, home healthcare, transit-operable.

Key topics and technical requirements

ISO 80601-2-69:2014 builds on the general IEC 60601-1 framework and adds particular requirements that reflect the unique risks of oxygen concentrators. Major technical topics include:

Scope and definitions specific to oxygen concentrators and accessories.
Identification, marking and documentation requirements (labelling, symbols and user information).
Protection against electrical and mechanical hazards, excessive temperature, unwanted radiation and contamination of breathing gas pathways.
Accuracy of controls and instruments, and protection against hazardous outputs (including oxygen delivery performance tests).
Hazardous situations and fault conditions testing, plus requirements for Programmable Electrical Medical Systems (PEMS).
Construction and ME system integration, including EMC (electromagnetic compatibility) considerations.
Accessories and interfaces: outlet connectors, signal input/output parts, remote-control and distributed alarm connections.
Infection control: requirements and tests for cleaning and disinfection procedures.
Fire risk mitigation: measures and tests to prevent propagation of fire into the concentrator and its accessories.
Performance characteristics: the standard recognises typical oxygen concentrations produced by concentrators (commonly ~82–96%, product gas up to ~95%) and requires validation of delivery performance.

Practical applications

This standard is applied to:

Design and development of home and portable oxygen concentrators.
Test protocols for verifying oxygen delivery, safety, EMC, cleaning/disinfection and fire resistance.
Selection and certification of accessories (tubing, conserving equipment, humidifiers, outlet connectors).
Integration of concentrators into larger ME systems (e.g., anaesthesia setups, filling systems).

Who uses this standard

Medical device manufacturers and designers of oxygen concentrators and accessories.
Certification and testing laboratories conducting safety and performance evaluations.
Regulatory authorities and conformity assessment bodies.
Biomedical engineers, procurement specialists and hospital/homecare teams assessing device compliance.

Related standards

IEC/ISO 60601-1 (general medical electrical safety)
IEC 60601-1-11 (home healthcare environment)
IEC 60601-1-2 (electromagnetic compatibility) and other collateral standards referenced within ISO 80601-2-69.

ISO 80601-2-69:2014 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Practical applications

Who uses this standard

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Practical applications

Who uses this standard

Related standards

Related standards

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