Oxygen Concentrator Testing: ISO 80601-2-69, IEC 60601-1 and IEC 60601-1-2

A medical oxygen concentrator needs medical electrical safety and electromagnetic compatibility (EMC) testing before it reaches the market. This article covers which standards apply, how the particular, general and collateral standards fit together, which SUNGO company and laboratory does the work, which accreditation the report falls under, and what to prepare before submitting a unit.

The short answer

• Safety testing of an oxygen concentrator is built around the particular standard: ISO 80601-2-69 internationally, EN ISO 80601-2-69 in its European designation, and the mandatory industry standard YY 9706.269 in China. The particular standard is applied together with the general standard IEC 60601-1 / EN 60601-1 / GB 9706.1.
• If the concentrator is intended for use at home, the home healthcare collateral standard IEC 60601-1-11 / EN 60601-1-11 / YY 9706.111 also needs to be assessed. The particular standard itself sets requirements for technical alarm conditions (Table 201.101 of the 2020 edition), and the alarm system and alarm signals are assessed against the alarm collateral standard IEC 60601-1-8 / EN 60601-1-8 / YY 9706.108.
• EMC is tested to IEC 60601-1-2 / EN 60601-1-2 / YY 9706.102, as modified by the particular standard (Clause 202 in the 2020 edition). The scope also lists CISPR 11 and IEC 61000-3-2, -3-3, -4-2, -4-3, -4-4, -4-5, -4-6, -4-8, -4-11 and -4-39 separately as basic emission and immunity standards, with the corresponding EN and GB designations (see the table below).
• All of the standards listed above are within the scope of the Hefei laboratory's IAS accreditation (TL-1119). The scope lists them as whole standards, with no excluded clauses and no edition years.
• The particular standard also makes the usability collateral standard IEC 60601-1-6 apply, as modified (subclause 201.1.3 of the 2020 edition). IEC 60601-1-6 is not in the Hefei laboratory's IAS scope.
• Biocompatibility testing of the breathing gas pathway is not in this scope either. Where it is needed, SUNGO subcontracts it to a laboratory holding the appropriate qualifications. Under the accreditation rules, the customer's agreement is obtained before subcontracting, and the report identifies the subcontracted items and the subcontractor.

Standards and scope

Particular standard: ISO 80601-2-69 / EN ISO 80601-2-69 / YY 9706.269

According to the abstract published on the ISO website, ISO 80601-2-69 applies to transit-operable and non-transit-operable oxygen concentrators, and to oxygen concentrators integrated into, or used with, other medical devices, ME equipment or ME systems. Examples in the abstract include concentrators with an integrated oxygen conserving, humidifier, liquid reservoir or gas cylinder filling function, and concentrators used with a flowmeter stand.

It also covers accessories that the manufacturer intends to connect to the concentrator and whose characteristics can affect its basic safety or essential performance. The abstract lists masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment. Oxygen concentrators for use with a medical gas pipeline system are outside its scope.

The abstract of the 2020 edition on the ISO website notes that these concentrators are typically used by a single patient in the home healthcare environment, including on private and public transportation and on commercial aircraft, and that they can also be used in professional healthcare facilities.

Keep three editions apart:

• The ISO website shows that the third edition, ISO 80601-2-69:2026, was published in April 2026 and replaces the second edition published in November 2020. The second edition had replaced the 2014 first edition.
• The FDA Recognized Consensus Standards database currently lists the second edition (2020-11) as recognition number 1-148 (complete standard), linked to product code CAW (Generator, Oxygen, Portable; 21 CFR 868.5440; Class II; 510(k)).
• In China, the current standard is YY 9706.269-2021, published on 2021-03-09 and implemented on 2023-05-01. It fully replaces YY 0732-2009. Its scope, as published on the national standards information platform, closely matches the description in the ISO abstract. Which ISO edition YY 9706.269-2021 is based on is stated in its foreword.

None of these three standard numbers carries an edition year in the Hefei laboratory's IAS scope. State the edition you need in your request, and the laboratory will confirm it when the request is reviewed.

General standard: IEC 60601-1 / EN 60601-1 / GB 9706.1

The particular standard is not used on its own. The scope text of ISO 80601-2-69 refers several times to clauses of the "general standard" (for example 7.2.13, 8.4.1 and 4.2), meaning IEC 60601-1. The Chinese counterpart is GB 9706.1-2020. The national standards information platform shows it as a modified adoption of IEC 60601-1:2012, published on 2020-04-09 and implemented on 2023-05-01.

Testing follows the particular standard together with the corresponding clauses of the general standard; the standard text defines which general-standard clauses are added to, replaced or deleted.

The particular standard also sets out how the collateral standards apply. Subclause 201.1.3 of ISO 80601-2-69:2020, for example, states that IEC 60601-1-2, IEC 60601-1-6 and IEC 60601-1-11 apply as modified in Clauses 202, 206 and 211 respectively, that IEC 60601-1-3 does not apply, and that all other published collateral standards in the IEC 60601-1 series apply as published. For the 2026 edition, refer to the standard text.

Home healthcare collateral standard: IEC 60601-1-11 / EN 60601-1-11 / YY 9706.111

YY 9706.111-2021 (published 2021-03-09, implemented 2023-05-01) sets basic safety and essential performance requirements for ME equipment and ME systems used in the home healthcare environment. It applies to equipment whose instructions for use state that it is intended for the home healthcare environment, including equipment intended for several environments of which home healthcare is one.

Concentrators are usually home-use products, so this collateral standard is normally assessed; whether it applies depends on the use environment stated in the instructions for use.

Alarm collateral standard: IEC 60601-1-8 / EN 60601-1-8 / YY 9706.108

YY 9706.108-2021 sets requirements for alarm systems and alarm signals in ME equipment and ME systems, and gives guidance on applying alarm systems. It fully replaces YY 0709-2009 and was implemented on 2023-05-01.

Part of the alarm requirements for an oxygen concentrator sits in the particular standard itself. Table 201.101 of ISO 80601-2-69:2020 lists as essential performance that the oxygen concentration in the delivered gas, in normal condition and single fault condition, stays within the performance levels indicated in the instructions for use, or an alarm condition is generated. The table refers to technical alarm conditions for power supply failure, internal electrical power source nearing depletion, low oxygen concentration, malfunction and the start-up period. The alarm system and alarm signals are assessed against IEC 60601-1-8 / YY 9706.108; the applicable clauses are defined in the standard text.

EMC: IEC 60601-1-2 / EN 60601-1-2 / YY 9706.102

YY 9706.102-2021 sets general EMC requirements and tests for ME equipment and ME systems. It fully replaces YY 0505-2012 and was implemented on 2023-05-01. Subclause 1.2 of IEC 60601-1-2:2014 states that the requirements of that collateral standard are in addition to the requirements of the general standard and serve as the basis for particular standards.

The basic emission and immunity standards listed separately in the Hefei laboratory's IAS scope are shown in the table below. The scope covers only the standards and parts listed there.

Which tests apply to a given concentrator, at what test levels, and how results are judged is defined in the particular standard's modifications to IEC 60601-1-2 (Clause 202 in the 2020 edition) together with IEC 60601-1-2 / YY 9706.102. A note to Table 201.101 of the 2020 edition states that subclause 202.8.1.101 gives methods for evaluating delivered oxygen concentration as acceptance criteria after the specified tests.

Outside the accreditation scope listed here

• Usability and other collateral standards: of the IEC 60601-1 collateral standards, the Hefei laboratory's IAS scope lists only IEC 60601-1-2, -1-8 and -1-11. IEC 60601-1-6 (applied as modified in Clause 206 under subclause 201.1.3 of the 2020 edition) and the other published IEC 60601-1 collateral standards are not in the scope. Check the applicable requirements in the standard text before placing a request.
• Breathing gas pathway biocompatibility: besides ISO 80601-2-69, the FDA page for product code CAW lists ISO 18562-1 to -4 (biocompatibility evaluation of breathing gas pathways in healthcare applications: evaluation within a risk management process, and tests for particulate matter emissions, volatile organic compound emissions and leachables in condensate). These standards are not in the Hefei laboratory's IAS scope. Where needed, SUNGO subcontracts them to a laboratory holding the appropriate qualifications; under the accreditation rules, the customer's agreement is obtained beforehand and the report identifies the subcontracted items and the subcontractor.
• Use on aircraft: use of a portable concentrator on commercial aircraft involves aviation requirements that are not in the scope listed here. Confirm them with the airline or the aviation authority.
• Other product standards cited in your product technical requirements, and safety or transport standards for the battery itself, are not in the scope listed here. Send us your full list of standards before testing so that each one can be checked.

Test items

The table below is taken from the oxygen concentrator entries in the IAS accreditation scope of Hefei SUNGO Medical Technology Co., Ltd. (TL-1119; scope effective date 2026-06-04), with the ISO/IEC, EN and GB/YY designations of each standard combined in one row. All are accredited as whole standards, with no edition years; "None" means the scope lists no specific clauses, exclusions or limitations.

The "Item" column reproduces the scope title of the ISO/IEC (or CISPR) entry in each row; the EN, GB and YY entries in the same row carry the same or similarly worded titles in the scope. Standard numbers are reproduced exactly as they appear in the scope.

Where SUNGO performs the work and under which accreditation

• Site: Hefei laboratory, Zipeng Town, Feixi County, Hefei, Anhui Province, China.
• Legal entity: Hefei SUNGO Medical Technology Co., Ltd., a separate legal entity, not a branch.
• Accreditation and certificate number: IAS accreditation, certificate TL-1119. The oxygen concentrator safety and EMC standards listed in the table are within the scope of the Hefei laboratory's IAS accreditation (TL-1119).
• Shanghai laboratory: Shanghai SUNGO Medical Technology Co., Ltd. is a separate legal entity, with its laboratory at 958 Kangqiao East Road, Pudong, Shanghai. The standards listed here are not in its accreditation scope, so oxygen concentrator safety and EMC testing is carried out in Hefei.

Whether a report is accepted for registration in a particular country or region, including mainland China, depends on the local regulator or notified body. Confirm the report requirements with your regulatory consultant or the reviewing authority first, then decide which standard designations and editions the report should cover.

Preparing for testing

• Standards and editions: State the target market, the standard designations you need (ISO/IEC, EN or GB/YY) and the edition years. The scope carries no edition years, so the edition is confirmed when your request is reviewed.
• Models and variants: List every model to be covered and how the models differ, for example the oxygen delivery mode, whether oxygen conserving or humidifier functions are integrated, whether the unit is designed to be transit-operable, and the power configuration.
• Configuration: A list of the main unit and supplied accessories. Because ISO 80601-2-69 covers accessories that can affect basic safety or essential performance, supply cannulae, humidifiers, external power sources, carrying cases and similar accessories with the main unit.
• Instructions for use and labelling: The intended use, the intended use environment (including home healthcare and use in vehicles, if applicable), technical specifications, warnings and maintenance requirements, plus drafts of the rating plate and markings.
• Essential performance and risk documents: The manufacturer's definition of essential performance and the parts of the risk management file relevant to the tests. For EMC, also describe how essential performance is monitored and judged during immunity testing.
• Sample condition: Production-equivalent samples with the software or firmware version fixed and stated; batteries and chargers for battery-powered units; a list of critical components with supporting documents.
• Electrical ratings: Rated voltage, frequency and input power, and the power adapter model. If assessment under several supply conditions is needed, say so in advance.

The number of samples, and any extra samples for disassembly or test fixtures, depend on the selected clauses and the product design; an engineer confirms this when the request is reviewed.

Frequently asked questions

Is IEC 60601-1 or GB 9706.1 alone enough for oxygen concentrator safety testing?

Usually not. Oxygen concentrators have their own particular standard, ISO 80601-2-69 (the mandatory standard YY 9706.269 in China), applied together with the general standard; home-use units also need IEC 60601-1-11 / YY 9706.111, and because the particular standard sets technical alarm requirements, the alarm system is assessed against IEC 60601-1-8 / YY 9706.108. The particular standard also applies the usability standard IEC 60601-1-6, as modified, which is not in the Hefei laboratory's IAS scope.

Which accreditation covers SUNGO's oxygen concentrator safety and EMC reports?

The reports are issued by the Hefei laboratory of Hefei SUNGO Medical Technology Co., Ltd., and the relevant standards are within the scope of its IAS accreditation (TL-1119), listed as whole standards. Whether a particular regulator accepts the report depends on that regulator's requirements.

What is the current edition of ISO 80601-2-69?

The ISO website shows the third edition, ISO 80601-2-69:2026, published in April 2026 and replacing the 2020 edition. The FDA Recognized Consensus Standards database currently lists the 2020 edition (recognition number 1-148), and the current Chinese standard is YY 9706.269-2021. State the edition your target market requires; which edition the report covers, and whether it is within the accreditation scope, is confirmed when the request is reviewed.

Can biocompatibility testing be ordered together with safety and EMC?

Yes, but SUNGO does not perform it. SUNGO subcontracts biocompatibility testing to a laboratory holding the appropriate qualifications; under the accreditation rules, the customer's agreement is obtained before subcontracting, and the report identifies the subcontracted items and the subcontractor.

Can the Shanghai laboratory test oxygen concentrators?

The oxygen concentrator safety and EMC standards listed here are not in the accreditation scope of Shanghai SUNGO Medical Technology Co., Ltd. This work is done at the Hefei laboratory, and the report is issued by Hefei SUNGO Medical Technology Co., Ltd.

Requesting a quote

For a quote or a check of your standards list, see our medical electrical safety testing and EMC testing service pages, then use the contact page to send the product models, target market, standard designations and editions, and a draft of the instructions for use. We first check each standard against the Hefei laboratory's IAS accreditation scope (TL-1119), then propose a test plan.