Alarm Systems in Medical Electrical Equipment: IEC 60601-1-8 and YY 9706.108

If your medical electrical equipment has an alarm system, that alarm system is normally evaluated against IEC 60601-1-8; the exact requirements depend on the general standard and any applicable particular standard. The alarm might flag an unsatisfactory physiological state of the patient, flag an unsatisfactory functional state of the equipment, or warn the operator of a hazard. In China the matching document is the mandatory industry standard YY 9706.108, and in Europe the standard carries the EN 60601-1-8 number. This article covers four things: how these numbers relate, what the standard looks at in an alarm system, which SUNGO laboratory does the work and under which accreditation, and what to prepare before you send samples.

Key points

• IEC 60601-1-8 is a collateral standard to the general standard IEC 60601-1. It specifies requirements for alarm systems and alarm signals in medical electrical (ME) equipment and ME systems and gives guidance on applying them. It is used together with the general standard. Where a particular standard applies, the particular standard's requirements take priority.
• The core aim is consistency. The standard defines alarm priorities by degree of urgency, sets characteristics for visual and auditory alarm signals, and makes the control states (such as pausing, switching off and resetting alarm signals) and their markings consistent. It also has dedicated subclauses on alarm presets, alarm limits, distributed alarm systems and alarm system logging.
• Check the edition. The latest IEC consolidated version is Edition 2.2 (published July 2020), which includes Amendment 1 (2012) and Amendment 2 (2020). China's YY 9706.108-2021 is a modified adoption of IEC 60601-1-8:2006+AMD1:2012 and has applied since 1 May 2023.
• IEC 60601-1-8, EN 60601-1-8 and YY 9706.108 are all within the IAS accreditation scope of our Hefei laboratory (TL-1119). Each is listed as a whole standard with no stated limitation, and the scope gives no edition years.
• The standard does not say which equipment must have an alarm system. It also does not say which situations count as alarm conditions or what priority each one gets. Those questions are settled by particular standards and by the manufacturer's risk management.

The standards and their scope

How the three numbers relate

IEC 60601-1-8 has the full title "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". Its foreword says it was prepared by IEC SC 62A together with ISO/TC 121/SC 3 and is published as a double-logo standard. The latest IEC consolidated version is Edition 2.2 (CSV), published 2020-07-23. It combines the second edition (2006), Amendment 1 (2012) and Amendment 2 (2020). The IEC Webstore gives a stability date of 2028. The earlier Edition 2.1 consolidated version was published on 2012-11-28 and consists of the second edition (2006) and Amendment 1 (2012).

YY 9706.108: China's National Public Service Platform for Standards Information lists YY 9706.108-2021 (Chinese title: 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) as 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, fully replaces YY 0709-2009 and is current. Draft standards GB 9706.284 and YY 0893, published on the Shanghai Medical Products Administration website, cite it as "IEC 60601-1-8:2006+AMD1:2012, MOD". In other words, it is a modified adoption of Edition 2.1.

EN 60601-1-8 is the standard of the same title under the European (EN) numbering, used for the European market. Check the foreword of the EN text for which IEC edition and amendments it corresponds to.

This has a practical consequence. YY 9706.108-2021 is based on IEC Edition 2.1 and does not include Amendment 2 (2020), while the latest IEC consolidated version is Edition 2.2. If the same device is going to China and to other markets, state the edition of each standard separately on your test request.

For the United States, the FDA Recognized Consensus Standards database lists IEC 60601-1-8 Edition 2.2 2020-07 Consolidated Version under recognition number 5-131. The extent of recognition is "Complete standard" and the date of entry is 2020-12-21. The same entry names ANSI/AAMI/IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] as an identical adoption.

Scope: what the standard covers and what it leaves out

According to Clause 1 of IEC 60601-1-8, the standard applies to the basic safety and essential performance of ME equipment and ME systems. It specifies requirements for alarm systems and alarm signals and gives guidance on applying alarm systems. Its object is to specify basic safety and essential performance requirements and tests for alarm systems. It does this in three ways: it defines alarm categories (priorities) by degree of urgency, it makes alarm signals consistent, and it makes control states and their marking consistent. The scope given for YY 9706.108-2021 on the Chinese standards platform broadly matches the wording of IEC subclause 1.1.

The standard also states what it does not specify:

• whether any particular ME equipment or ME system is required to have an alarm system;
• the particular circumstances that initiate an alarm condition;
• the allocation of priorities to a particular alarm condition;
• the means of generating alarm signals.

For these points, look to the particular standard or to the manufacturer's risk management. Subclause 1.3 also says that, for ME equipment and ME systems, the standard complements IEC 60601-1, and that a requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.

Basic terms

Three definitions from YY 9706.108-2021, as quoted with clause references in the YY 0893 draft on the Shanghai Medical Products Administration website:

• Alarm condition (3.1): the state of the alarm system when it has determined that a potential or actual hazardous situation exists for which operator awareness or response is required. An alarm condition can be invalid (a false positive) or can be missed (a false negative).
• Alarm limit (3.3): the threshold used by the alarm system to determine an alarm condition.
• Alarm signal (3.9): the type of signal generated by the alarm system to indicate the presence (or occurrence) of an alarm condition.

In Edition 2.2, the definition of alarm condition delay separates two cases: for a physiological alarm condition the triggering event is in the patient, and for a technical alarm condition it is in the equipment. The introduction also explains that information signals convey information independent of an alarm condition.

What the standard examines (based on the Edition 2.2 table of contents)

The main clauses of IEC 60601-1-8 Edition 2.2 are listed below. YY 9706.108-2021 is based on Edition 2.1, so check its text for the exact Chinese terms and clause content.

• Clause 4 General requirements: according to the foreword, the main technical change in the second edition is in Clause 4, which now recognizes the general requirement for a risk management process in IEC 60601-1:2005.
• Clause 5 ME equipment identification, marking and documents: 5.1 Indicator lights and controls; 5.2 Accompanying documents.
• 6.1 Alarm condition: Table 1 covers determination of alarm conditions and assignment of priorities. The priority terms used are high priority, medium priority and low priority.
• 6.2 Disclosures for intelligent alarm system.
• 6.3 Generation of alarm signals: Table 2 gives the characteristics of alarm indicator lights. Tables 3 and 4 give the characteristics of the burst and of the pulse of auditory alarm signals, and Figure 1 shows the temporal characteristics of auditory alarm signals. Both visual and auditory alarm signals are evaluated under this subclause.
• 6.4 Disclosure of delays: Figure A.1 in Annex A shows the components of alarm system delay.
• 6.5 Alarm presets and 6.6 Alarm limit.
• 6.7 Alarm system security: the introduction stresses that how well an alarm system works depends critically on how the responsible organization implements it, and that the responsible organization should configure it so that an operator cannot compromise it.
• 6.8 Alarm signal inactivation states: Table 5 lists the inactivation states. Related terms include audio paused, alarm paused, audio off and alarm off.
• 6.9 Alarm reset and 6.10 Non-latching and latching alarm signals.
• 6.11 Distributed alarm system and distributed information systems about alarm conditions: Figure 2 shows the functions of a distributed alarm system that uses a medical IT network.
• 6.12 Alarm system logging and 6.13 Alarm system functions: Figure 3 shows the functions of an alarm system.

The annexes are as follows. Annex C (normative) covers the symbols used on markings for alarm systems. Annex F (normative) is titled "Reserved melodies for alarm signals". Annex G (normative) covers auditory alarm signals, including the characteristics of the auditory pointer and the auditory icon. Annexes D, E and H are informative and cover guidance for auditory alarm signals, verbal alarm signals and validation of auditory icons. Annex A gives general guidance and rationale, and Annex B is a guide to the marking and labelling requirements.

The normative references in Edition 2.2 include the general standard IEC 60601-1, IEC 61672-1 (sound level meters), ISO 3744 (sound power determined from sound pressure), IEC 62366-1 (usability engineering), and IEC 60417 and ISO 7000 (graphical symbols). The foreword explains that requirements and definitions are set in roman type and test specifications in italic type. How compliance is judged is set by the text of each clause.

Test scope table

The table lists the entries in the Hefei laboratory's IAS accreditation scope (TL-1119) that are relevant to this article. The alarm collateral standard is used together with the general standard, so the three general-standard entries are included as well.

Where SUNGO does this work and under which accreditation

• Laboratory: Hefei laboratory, in Zipeng Town, Feixi County, Hefei, Anhui Province, China.
• Legal entity: Hefei SUNGO Medical Technology Co., Ltd., an independent company, not a branch.
• Accreditation: IAS, certificate TL-1119, scope effective 2026-06-04. IEC 60601-1-8, EN 60601-1-8 and YY 9706.108 are all within the IAS accreditation scope of the Hefei laboratory (TL-1119).

Keep three things in mind.

1. The IAS scope lists standards by number without edition years. State the exact edition on your request, for example IEC 60601-1-8 Edition 2.2 or YY 9706.108-2021, and the laboratory will confirm it before testing.
2. The IAS certificate carries the ilac-MRA mark. Before testing, check with the relevant regulator or notified body whether the report can be used for registration or certification in a given market, including NMPA registration testing in China.
3. Several standards often evaluated alongside the alarm standard are also within the Hefei laboratory's IAS scope (TL-1119): the general standard IEC 60601-1 / EN 60601-1 / GB 9706.1; the home healthcare collateral standard IEC 60601-1-11 / EN 60601-1-11 / YY 9706.111; the EMC collateral standard IEC 60601-1-2 / EN 60601-1-2 / YY 9706.102; and the oxygen concentrator particular standard ISO 80601-2-69 / EN ISO 80601-2-69 / YY 9706.269. Apart from the oxygen concentrator particular standards above, no IEC 60601-2, ISO 80601-2, GB 9706.2 or YY 9706.2 series particular standards are in this scope. If another particular standard applies to your product, tell us when you ask for a quotation so we can first check whether it is covered.

Preparing your submission

An alarm system evaluation looks at both the sample and the documentation. These are general preparation points. The exact list depends on your product configuration.

• Model and configuration description: the model and specification being submitted, and how the configurations differ, for example whether networking, remote alarms or add-on modules are included.
• Instructions for use and technical description: Clause 5 covers marking and accompanying documents, and Annex B gives a guide to the related requirements.
• Alarm list: for each alarm condition, state whether it is physiological or technical, its trigger, its priority, the matching visual and auditory alarm signals, any delays, the preset values and the adjustable range. Clause 6 is checked item by item against this list.
• Risk management documentation: how alarm conditions are determined and how priorities are assigned have to be read together with risk management (see Clause 4), so please provide the relevant risk management records.
• Usability documentation: IEC 62366-1 is a normative reference. If you already have a usability engineering file, please include it.
• Sample state: the software and hardware versions of the sample must match those in your submission. Explain how to trigger each alarm condition (for example a test mode, a simulator or step-by-step instructions) and how to view or export the alarm system log.
• Distributed alarms: if the product sends alarm information over a network to a central station or another device, provide the receiving equipment or describe the network configuration.
• Applicable standards list: state the target markets, the applicable particular standards and the edition of each standard.

FAQ

Are IEC 60601-1-8 and YY 9706.108 the same standard?

They share the same source but are based on different editions. YY 9706.108-2021 is a modified adoption of IEC 60601-1-8:2006+AMD1:2012 and has applied since 2023-05-01, whereas the latest IEC consolidated version, Edition 2.2, also includes Amendment 2 (2020). Choose the edition that fits your target market and state it on your request.

Does equipment without an alarm function need IEC 60601-1-8?

IEC 60601-1-8 itself does not say which equipment must have an alarm system. That depends on the applicable particular standard and the manufacturer's risk management. Where equipment does have an alarm system, that alarm system is normally evaluated against this standard.

If a particular standard also has alarm requirements, which one applies?

Subclause 1.3.2 of IEC 60601-1-8 says that a requirement in a particular standard takes priority over the corresponding requirement in the collateral standard. If your product has a particular standard, read it side by side with the collateral standard.

Which SUNGO laboratory does alarm system testing, and under which accreditation?

The work is done by the Hefei laboratory of Hefei SUNGO Medical Technology Co., Ltd., within its IAS accreditation scope (TL-1119). The scope lists IEC 60601-1-8, EN 60601-1-8 and YY 9706.108 as whole standards without edition years. The exact edition is confirmed when you place the request.

Does the US FDA recognize IEC 60601-1-8?

The FDA Recognized Consensus Standards database lists IEC 60601-1-8 Edition 2.2 2020-07 Consolidated Version under recognition number 5-131. The extent of recognition is "Complete standard" and the date of entry is 2020-12-21.

Request a quotation

If your product has an alarm system and you are preparing its medical electrical safety evaluation, start with our medical electrical safety testing service. If you also need EMC testing, see our EMC testing service. When you ask for a quotation, tell us the product name, model, target markets and the editions of the applicable standards, and attach the instructions for use and the alarm list. Send it through our contact page.