YY 9706.261-2023 Active Industry standards-Medicine

YY 9706.261-2023 Medical electrical equipment—Part 2-61:Particular requirements for the basic safety and essential performance of pulse oximeter equipment

YY 9706.261-2023 Medical electrical equipment—Part 2-61:Particular requirements for the basic safety and essential performance of pulse oximeter equipment

Publish Date: 2023-01-13 Implement Date: 2026-01-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY 9706.261-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical electronic instruments and equipment

ICS Name: Anesthesia, respiration, and resuscitation equipment

Publish Date: 2023-01-13

Implement Date: 2026-01-15

Pages: 84 pages

Scope

This part of GB 9706 specifies the general requirements for the basic safety and basic performance of ME devices and ME systems.
This part applies to medical electrical equipment and medical electrical systems (hereinafter referred to as ME devices and ME systems).
If a chapter or a clause explicitly states that it only applies to ME devices or ME systems, the title and the text of the chapter or clause will indicate this. If this is not the case, the relevant chapter or clause applies to both ME devices and ME systems.
Except for 7.2.13 and 8.4.1, the hazards (sources) caused by the intended physiological effects of ME devices or ME systems within the scope of this part are not specifically required in this part.
Replacement:
This document specifies the basic safety and basic performance of pulse oximetry devices (hereinafter referred to as ME devices).
This document applies to pulse oximetry devices used by humans and repaired pulse oximetry devices. ME devices include pulse oximetry monitors, pulse oximetry probes, and probe cable extensions.
This document applies but is not limited to pulse oximetry devices intended to estimate the arterial oxygen saturation and pulse rate of patients in professional medical institutions, home care environments, and emergency medical services environments.
This document also applies to pulse oximetry devices for compensating or alleviating diseases, injuries, or disabilities, and pulse oximetry devices intended for use in extreme or uncontrolled environments outside hospitals or doctors' offices, such as ambulances and airborne transfers. Supplementary standards apply to pulse oximetry devices used in these environments.
This document does not apply to pulse oximetry devices used for laboratory research or blood oxygen meters requiring the collection of patient blood samples.
This document does not apply to fetal-specific pulse oximetry devices.
This document does

Development Information

Word Count: 158 Thousand words Pages: 84 pages

Same series standard

YY 9706.230-2023 Medical electrical equipment—Part 2-30:Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers YY 9706.231-2023 Medical electrical equipment—Part 2-31:Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source YY 9706.246-2023 Medical electrical equipment—Part 2-46:Particular requirements for the basic safety and essential performance of operating tables YY 9706.249-2023 Medical electrical equipment—Part 2-49:Particular requirements for the basic safety and essential performance of multifunction patient monitors YY 9706.256-2023 Medical electrical equipment—Part 2-56:Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement YY 9706.277-2023 Medical electrical equipment—Part 2-77:Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment YY 9706.278-2023 Medical electrical equipment—Part 2-78:Particular requirements for basic safety and essential performance of medical robots for rehabilitation,assessment,compensation or alleviation YY 9706.279-2023 Medical electrical equipment—Part 2-79:Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment YY 9706.280-2023 Medical electrical equipment—Part 2-80:Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency YY 9706.284-2023 Medical electrical equipment—Part 2-84:Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

Replace the following standards

YY 0784-2010 Medical electrical equipment—Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use

Referenced Standards

GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical 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16:Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2013 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation GB 16895.21-2004 Electrical installations of buildings—Part 4-41:Protection for safety-Protection against electric shock GB/T 16895.21-2011 Low-voltage electrical installations—Part 4-41:Protection for safety—Protection against electric shock GB/T 16895.21-2020 Low-voltage electrical installations—Part 4-41:Protection for safety—Protection against electric shock GB/T 16935.1-2008 Insulation coordination for equipment within low-voltage systems—Part 1:Principles,requirements and tests GB 17465.1-1998 Appliance couplers for household and similar general purposes Part 1:General requirements GB/T 17465.1-2009 Appliances couplers for household and similar general purposes—Part 1:General requirements GB/T 17465.1-2022 Appliance couplers for household and similar general purposes—Part 1:General requirements GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 19212.2-2006 Safety of power transformers, power supply units and similar—Part 2:Particular requirements for separating transformers for general use GB/T 19212.2-2012 Safety of power transformers, power supplies, reactors and similar products—Part 2:Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications GB/T 19212.2-2025 Safety of transformers, reactors, power supply units and combinations thereof—Part 2:Particular requirements and tests for separating transformers and power supply units incorporating separating transformers for general applications GB/T 23821-2009 Safety of machinery—Safety distances to prevent hazard zones being reached by upper and lower limbs GB 27701-2011 Mechanical safety of cathode ray tubes GB/T 28164-2011 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells,and for batteries made from them,for use in portable application GB/T 28164.2-2025 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells,and for batteries made from them,for use in portable applications—Part 2:Lithium systems YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements YY 0505-2005 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY/T 0664-2008 Medical device software—Software life cycle processes YY 0709-2009 Medical electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ISO 2882 ISO 3864-1:2002 ISO 7000:2004 ISO 7010:2011 ISO 9614-1 ISO 80000-1:2009 IEC 60601-1-6 IEC 60730-1:2010 IEC 60851-3:2009 IEC 60851-5:2008 GB/T 4208-2017 Degrees of protection provided by enclosure(IP code) GB 7247.1-2001 Safety of laser products—Part 1:Equipment classification, requirements and user's guide GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements GB/T 7247.1-2024 Safety of laser products—Part1:Equipment classification and requirements YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability YY 9706.108-2021 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 GB/T 2423.5-2019 Environmental testing—Part 2:Test methods—Test Ea and guidance:Shock GB/T 2423.56-2018 Environmental testing—Part 2:Test methods—Test Fh:Vibration, broadband random and guidance GB/T 3767-2016 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Engineering methods for an essentially free field over a reflecting plane GB/T 7247.2-2018 Safety of laser products—Part 2:Safety of optical fibre communication systems(OFCS) GB/T 16273.1-2008 Graphical symbols for use on equipment—Part 1:Common symbols GB/T 31523.1-2015 Safety information identification systems—Part 1:Signs YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 1474-2016 Medical devices—Application of usability engineering to medical devices YY 9706.111-2021 Medical electrical equipment—Part 1-11:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment YY 9706.112-2021 Medical electrical equipment—Part 1-12:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment ISO 4135:2001

Adopt standards

ISO 80601-2-61:2017

Related Standards

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YY/T 0338.1-2002 Tracheostomy tubes—Part 1:Tubes and connectors for adults

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