Home Healthcare Medical Devices: What IEC 60601-1-11 Adds to IEC 60601-1

If the instructions for use of your medical electrical (ME) equipment say it can be used at home, or the device is meant for both hospital and home use, the general safety standard IEC 60601-1 does not cover everything. Under its scope, the collateral standard IEC 60601-1-11 also applies; in China, the corresponding mandatory standard is YY 9706.111. This guide walks through the standard's table of contents to explain what it examines on top of the general standard, which products are in scope, where the testing is done at SUNGO and under which accreditation, and what to prepare before you send samples.

Key points

• Scope depends on the intended use environment. IEC 60601-1-11 applies to ME equipment and ME systems that the manufacturer's instructions for use specify for the home healthcare environment, whether the operator is a lay person or trained healthcare personnel.
• Dual-use devices are included. Equipment intended for several use environments is in scope as long as one of them is the home healthcare environment. Equipment intended solely for professional healthcare facilities, or solely for the emergency medical services environment (covered by IEC 60601-1-12), is out of scope.
• It is not used on its own. It complements the general standard IEC 60601-1. Where a particular standard exists, the corresponding requirement in the particular standard takes priority.
• The additional topics are supply mains, transport, storage and operating conditions, accompanying documents, cleaning and disinfection, ingress of water and particulate matter, power interruption and internal power sources, mechanical strength, strangulation and asphyxiation, electromagnetic emissions, and alarm systems.
• The Chinese standard is mandatory. YY 9706.111-2021 has applied since 1 May 2023, the same date as GB 9706.1-2020.
• At SUNGO the work is done by the Hefei laboratory, within the scope of its IAS accreditation (TL-1119). The scope covers IEC/EN 60601-1-11 and YY 9706.111 as whole standards, together with the general, EMC, alarm and oxygen concentrator standards listed in the test items table below.

The standard and its scope

Edition history

IEC 60601-1-11 is titled "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". It was prepared by a joint working group of IEC subcommittee 62A and ISO/TC 121/SC 3 and is published as a double-logo standard. IEC 60601-1-11 was originally published in 2010. The second edition, published in 2015, cancelled and replaced the 2010 edition, and Amendment 1 followed in 2020. The version currently offered by the IEC webstore is the consolidated IEC 60601-1-11:2015+AMD1:2020 CSV (edition 2.1), published on 2020-07-22, with a stability date of 2028.

According to the IEC, the main changes in the second edition were: a corrected test method for relative humidity control at temperatures above 35 °C; redrafted subclauses that had altered, rather than added to, the general standard or other collateral standards; and alignment with the amendments to the general standard and the other collateral standards.

What counts as the home healthcare environment

Subclause 3.1 defines the home healthcare environment as the dwelling place in which a patient lives, or other places where patients are present. It excludes professional healthcare facility environments where operators with medical training are continually available when patients are present. The examples given are being in a car, bus, train, boat or plane, in a wheelchair, or walking outdoors.

Note 1 to entry lists what counts as a professional healthcare facility, including hospitals, physician offices, freestanding surgical centres and dental offices. Note 2 says that, for the purpose of this collateral standard, nursing homes are considered home healthcare environments. Note 3 adds that other places where a patient is present include the outdoor environment, while working, and in vehicles.

The scope clause also carries a note that equipment used in the home healthcare environment is frequently used in locations with unreliable electrical sources and poor electrical grounding.

Relationship with the general standard and particular standards

Under subclauses 1.2 and 1.3, the collateral standard specifies general requirements that are in addition to those of the general standard and serves as the basis for particular standards. In the text, "the general standard" means IEC 60601-1 including its amendments, and "this standard" means the general standard and the collateral standard taken together. A requirement in a particular standard takes priority over the corresponding requirement in the collateral standard.

Oxygen concentrators are a good example. The scope of the second edition of ISO 80601-2-69 (2020) states that such concentrators are typically intended for use in the home healthcare environment by a single patient, including on private and public transport and in commercial aircraft. That is the edition listed under FDA recognition number 1-148; the ISO website shows the 2020 edition as withdrawn on 2026-04-10 and revised by ISO 80601-2-69:2026.

China: YY 9706.111-2021

The Chinese counterpart is YY 9706.111-2021, a mandatory pharmaceutical industry standard under the National Medical Products Administration (NMPA). It was issued on 2021-03-09, took effect on 2023-05-01 and is currently in force. Its scope is worded in the same way as the IEC version. It does not apply to equipment intended solely for the emergency medical services environment described in YY 9706.112, or solely for professional healthcare facilities under GB 9706.1. The Chinese general standard GB 9706.1-2020 took effect on the same date and is a modified adoption of IEC 60601-1:2012. For detailed technical differences between YY 9706.111 and the IEC text, refer to the standards themselves.

FDA recognition and the EN version

In the FDA Recognized Consensus Standards database, IEC 60601-1-11 edition 2.1 has partial recognition (recognition number 19-38). The part that is not recognized is Note 2 to entry in subclause 3.1, which treats nursing homes as home healthcare environments. FDA's reason is that this note conflicts with the definition of a professional healthcare facility in its guidance "Design Considerations for Devices Intended for Home Use", issued in November 2014. The database also lists the US adoption ANSI/AAMI HA60601-1-11:2015 (including the 2021 amendment, identified as IEC 60601-1-11:2015 MOD), which has complete recognition (recognition number 19-47).

EN 60601-1-11 is the European-numbered version of the standard. Which edition to use for a given market depends on that market's requirements.

What IEC 60601-1-11 adds to the general standard

The topics below follow the table of contents of IEC 60601-1-11:2015+AMD1:2020. Clause numbers are those of the IEC consolidated version; for the clause structure of YY 9706.111, refer to the Chinese text. This guide describes what each clause covers and does not quote limits or pass/fail values.

1. Supply mains and environmental conditions (Clause 4)

• 4.1: additional requirements for supply mains for ME equipment and ME systems.
• 4.2.2: environmental conditions of transport and storage between uses. Refer to the standard for how it applies.
• 4.2.3: additional requirements for environmental operating conditions. Refer to the standard for the actual conditions.

2. Marking, accompanying documents and instructions for use (Clause 7)

The introduction to the standard notes that lay operators, and possibly the people supervising them, may lack training and differ in level of education. The accompanying documents and the marking on the equipment therefore have to be understandable to them, and the standard gives specific guidance on how to write the instructions for use.

• 7.1: usability of the accompanying documents. 7.2: additional requirements for marking of the IP classification.
• 7.3: accompanying documents, including contact information (7.3.1) and lay operator briefing information (7.3.2).
• 7.4: additional requirements for the instructions for use, covering warning and safety notices, the electrical power source, equipment description, start-up procedure, operating instructions, equipment messages, cleaning, disinfection and sterilization, maintenance, and environmental protection.
• 7.5: technical description, including permanently installed Class I ME equipment and professional hygienic maintenance.

Annex B summarizes the marking and labelling requirements and Annex C lists symbols used in marking. The normative references include the symbol and labelling standards ISO 15223-1, ISO 7000 and ISO 7010.

3. Cleaning, ingress and power (Clause 8)

• 8.1 and 8.2: additional requirements for cleaning and disinfection, and for sterilization, of ME equipment and ME systems.
• 8.3: ingress of water or particulate matter into ME equipment and ME systems, with IEC 60529 (IP code) as a normative reference. Table A.2 in Annex A summarizes the enclosure requirements by type of use.
• 8.4: interruption of the power supply or supply mains. 8.5: internal electrical power sources, covering indication of state, accessibility of small internal electrical power sources, and separation of parts.

4. Controls and mechanical strength (Clauses 9 and 10)

• Clause 9: accuracy of controls and instruments, and protection against hazardous outputs.
• 10.1: additional requirements for mechanical strength. Table 1 sets out which tests apply to non-transit-operable equipment and Table 2 to transit-operable equipment (equipment that can be used while being transported). The normative references include IEC 60068-2-27 (shock), IEC 60068-2-31 (rough handling shocks) and IEC 60068-2-64 (broadband random vibration).
• Table A.3 in Annex A gives a qualitative assessment of home healthcare equipment subjected to shock and vibration. 10.2 adds requirements for actuating parts of controls.

5. Strangulation, emissions and alarms (Clauses 11 to 13)

• Clause 11: protection against strangulation or asphyxiation.
• Clause 12: additional requirements for electromagnetic emissions, with CISPR 11 and IEC 60601-1-2 as normative references.
• Clause 13: additional requirements for alarm systems, covering generation of alarm signals and alarm signal volume, with IEC 60601-1-8 as a normative reference.

So a home-use device with alarms also needs to be assessed against IEC 60601-1-8 / YY 9706.108, and EMC is assessed against IEC 60601-1-2 / YY 9706.102. The usability standards IEC 60601-1-6 and IEC 62366-1, which also appear in the normative references, are not within SUNGO's accreditation scope. The other referenced standards (IEC 60529, the IEC 60068-2 series and the symbol standards) are not listed separately in the certificate either.

Test items within the accreditation scope

The table below is taken from the IAS accreditation scope (TL-1119) of Hefei SUNGO Medical Technology Co., Ltd.:

The "Item" column reproduces the item field of the certificate. The certificate lists no clauses and no edition years, so the "Basis" column gives the standard number. The limitation field is empty for every row, meaning no limitation is listed; the descriptions in the notes column have been added in this guide to help identify each standard. The edition to be used in the report is agreed when the test order is placed; whether that edition falls within the IAS scope is confirmed against the certificate and the accreditation rules.

Where the testing is done and under which accreditation

• Site and legal entity: the Hefei laboratory in Zipeng Town, Feixi County, Hefei, Anhui Province, operated by Hefei SUNGO Medical Technology Co., Ltd., an independent legal entity. Shanghai SUNGO Medical Technology Co., Ltd. is a separate company, and its accreditation scope does not include medical electrical safety.
• Accreditation: the Hefei laboratory, within the scope of its IAS accreditation (TL-1119). The IAS certificate carries the ILAC MRA mark. Whether a report will be accepted by a particular regulator or certification body depends on that body's requirements, so please check with them before testing.
• Outside the scope: the only particular standard in the certificate is the oxygen concentrator group listed above. Other particular standards (for example YY 9706.261 for pulse oximeter equipment), IEC 60601-1-12 and ANSI/AAMI HA60601-1-11 are not within the accreditation scope.
• Biocompatibility: where patient-contacting parts need biological tests such as cytotoxicity, sensitization or irritation, SUNGO subcontracts them to an appropriately qualified laboratory. Under the accreditation rules, the client's consent to subcontracting is obtained in advance, and the report identifies the subcontracted items and the subcontractor.

Preparing for testing

1. Models and variants: the model to be tested, the models it is meant to cover, and a description of the differences between them (power configuration, software version, accessories, construction).
2. Intended use environment: whether the device is for home use, whether it is also used in professional facilities, and whether it is used while in transit. This decides whether mechanical strength under Clause 10 is assessed against Table 1 (non-transit-operable) or Table 2 (transit-operable); for how Clause 4 environmental conditions apply, refer to the standard.
3. Configuration: supply mains, batteries, external power adapters, the charging method and the accessory list; for devices with alarms, the alarm types and how they are set.
4. Instructions for use and technical description: the same version that will go to market, with complete briefing information, contact details, cleaning and disinfection instructions (including recommended cleaning and disinfecting agents) and maintenance instructions.
5. Labels and marking: drafts or physical samples of the rating plate, warning labels, IP marking and symbols.
6. Sample condition: production-equivalent units with all accessories. For tests that may damage samples, discuss in advance whether extra samples are needed; the number depends on the project.
7. Essential performance: the manufacturer's identification of essential performance and the related risk analysis, used to decide what is observed during the tests.
8. Applicable standards: the combination of general, collateral and particular standards, and the edition requirements of the target markets (China registration, the US, the EU and so on).

FAQ

Is IEC 60601-1 enough for a home-use medical device?

No. Under the scope of IEC 60601-1-11, equipment whose instructions for use specify the home healthcare environment also falls under that collateral standard. In China, GB 9706.1 and YY 9706.111 are both mandatory standards; for other markets, follow local requirements.

Does a device used both in hospitals and at home need IEC 60601-1-11?

Yes. The scope states that equipment intended for several use environments is covered as long as one of them is the home healthcare environment.

Is a nursing home a home healthcare environment?

Under Note 2 to entry in subclause 3.1 of IEC 60601-1-11, yes. However, FDA gives the IEC edition (recognition number 19-38) only partial recognition, and that note is the part it does not recognize, because it conflicts with the definition of a professional healthcare facility in FDA's 2014 guidance on design considerations for devices intended for home use.

Where does SUNGO test to IEC 60601-1-11, and under which accreditation?

At the Hefei laboratory (Hefei SUNGO Medical Technology Co., Ltd.), within the scope of its IAS accreditation (TL-1119). The scope covers IEC/EN 60601-1-11 and YY 9706.111 as whole standards, plus the general, EMC, alarm and oxygen concentrator standards listed in the table above.

Requesting a quote

Start with our medical electrical safety testing page. If EMC is also needed, see EMC testing. For biological tests, see biocompatibility (subcontracted). Once you have the model list, a statement of the intended use environment and the instructions for use, send your request through our contact page, and we will confirm the combination of standards that applies to your product and target markets.