BS EN ISO 80601-2-61:2011
Medical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeter equipment

Standard No.

BS EN ISO 80601-2-61:2011

Release Date

2011

Published By

British Standards Institution (BSI)

Status

Be replaced

Replace By

BS EN ISO 80601-2-61:2019

Latest

BS EN ISO 80601-2-61:2019

Replace

BS EN ISO 9919:2009

Scope

Subclause 1.1 of The general standard is replaced by: This International Standard 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. This International Standard 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 standard are not covered by specific requirements in this standard except in 201.11 and in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This standard can also be applied to PULSE OXIMETER EQUIPMENT and their ACCESSORIES used for compensation or alleviation of disease, injury or disability. This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use. This International Standard is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the PATIENT ENVIRONMENT.

BS EN ISO 80601-2-61:2011 Referenced Document

• IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
• IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
• IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broad-band random and guidance
• IEC 60529:2001 Degrees of protection provided by enclosure (IP code)*， 2024-04-19 Update
• IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• IEC 60601-1-6:2010 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability
• IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• IEC 60601-1-9:2007 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
• IEC 60825-1:2007 Safety of laser products - Part 1: Equipment classification and requirements
• ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
• ISO 14937:2000 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
• ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

BS EN ISO 80601-2-61:2011 history

• 2019 BS EN ISO 80601-2-61:2019 Medical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeter equipment
• 2011 BS EN ISO 80601-2-61:2011 Medical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeter equipment
• 1970 BS EN ISO 9919:2009 Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
• 2005 BS EN ISO 9919:2005 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

BS EN ISO 80601-2-61:2011 Medical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeter equipment has been changed from BS EN ISO 9919:2009 Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.