The following is for evaluating Medical Equipment and their Alarm Systems to the requirements of the IEC 60601-1 Standards. This does not replace the Standards, so a purchased copy of the IEC and National standards should also be used. This is a free document that may be downloaded at MECA’s website: http://60601-1.com MECA ALARM STANDARDS CROSS-REFERENCE A comparative resource for those who work with Alarm Systems and the corresponding Standards in the field of Medical Electrical Equipment This is a select Cross-Reference of the major Alarm System portions of the ME Collaterals and Particulars. It is intended as a companion to IEC 60601-1-8 Ed. 2.1, organizing requirements and references for Medical Device Alarm Systems and Alarm Signal Testing. The clauses have been edited to create a condensed multi-standard collection for quick assessments and comparisons between related documents. References to “alarms” have been replaced with “Alarm Systems”, “Alarm Conditions”, “Alarm Signals” etc... Common terms such as “False Alarm” or parts of speech, such as “alarming”, have not been modified. In the clauses below, the typical SMALL CAPS formatting is removed from defined terms, so that we can focus on the information that is related to Alarm Systems. I have bolded key words, as well as imperatives such as "shall, required, necessary, must or has to" and recommendations such as "should, could, may or might". These modifications are intended to aid those who are encountering new information as well as industry veterans who must assess products relating to a variety of device categories. The document ends with a multi-standard Alarm-focused Dictionary. Don’t let your project suffer due to misunderstood terminology! Prepared By: Robert A. Koch Compliance Engineer 60601-1-8 Alarm Systems Expert MECA, Medical Equipment Compliance Associates, LLC 5060 W. Ashland Way Franklin, WI 53132 Email: [email protected] or [email protected] Phone: 262-752-4017 xt.108 eFax: 847-919-3512 Web: http://60601-1.com or http://mecalabs.com (Rev. Date 2015/02/16) TABLE OF CONTENTS IEC 60601-1 Edition 3.1 2012-08 General requirements for Basic Safety and Essential Performance IEC 60601-1-2 Edition 3.0 2007-03 Electromagnetic Compatibility IEC 60601-1-6 Edition 3.0 2013-10 Usability IEC 60601-1-11 Edition 1.0 2010-04 Home Healthcare Environment IEC 60601-1-12 Ed.1.0 2014 Emergency Medical Services Environment IEC 60601-2-2 Edition 5.0 2009-02 High Frequency Surgical Equipment and High Frequency Surgical Accessories IEC 60601-2-4 Edition 3.0 2010-12 Cardiac Defibrillators IEC 60601-2-10 Edition 3.0 2010-12 Cardiac Defibrillators ISO 80601-2-12 First edition 2011-04-15 Critical Care Ventilators ISO 80601-2-13 First edition 2011-08-01 Anaesthetic Workstation IEC 60601-2-16 Edition 4.0 2012-03 Haemodialysis, Haemodiafiltration and Haemofiltration Equipment IEC 60601-2-18 Edition 3.0 2009-08 Endoscopic Equipment IEC 60601-2-23 Edition 3.0 2011-02 Transcutaneous Partial Pressure Monitoring Equipment IEC 60601-2-24 Edition 2.0 2012-10 Infusion Pumps and Controllers IEC 60601-2-27 Edition 3.0 2011-03 Electrocardiographic Monitoring Equipment IEC 80601-2-30 Edition 1.1 2013-Automated Non-Invasive Sphygmomanometers IEC 60601-2-33 Edition 3.1 2013-04 Magnetic Resonance Equipment for Medical Diagnosis IEC 60601-2-34 Edition 3.0 2011-05 Invasive Blood Pressure Monitoring Equipment IEC 80601-2-35 Edition 2.0 2009 Heating Devices Using Blankets, Pads Mattresses Intended for Heating IEC 60601-2-37 Edition 2.0 2007-08 Ultrasonic Medical Diagnostic and Monitoring Equipment IEC 60601-2-39 Edition 2.0 2007-11 Peritoneal Dialysis Equipment IEC 60601-2-47 Edition 2.0 2012-02 Ambulatory Electrocardiographic Systems IEC 60601-2-49 Edition 2.0 2011-02 Multifunction Patient Monitoring Equipment ISO 80601-2-55 First edition 2011-12-15 Respiratory Gas Monitors ISO 80601-2-56 First edition 2009-10-01 Clinical Thermometers for Body Temperature Measurement ISO 80601-2-61 First edition 2011-04-01 Pulse Oximeter Equipment ME ALARM DICTIONARY Terms related to Medical Electrical Equipment Alarm Systems ANSI / AAMI ES60601-1:2005 (IEC 60601-1:2005) / (R) 2012 and A1:2012, C1:2009 / (R) 2012 and A2:2010 / (R) 2012 General requirements for Basic Safety and Essential Performance 4.3 * Essential Performance - During Risk Analysis, the Manufacturer shall identify the performance of the clinical function(s) of the ME Equipment or ME System, other than that related to Basic Safety, that is necessary to achieve its Intended Use or that could affect the safety of the ME Equipment or ME System. NOTE 1: The performance of the Risk Control measure might well become an aspect of the Essential Performance of the ME Equipment or ME System. For example, the generation of the Alarm Signal to indicate the interruption of the Supply Mains could be “essential” if an interruption of the Supply Mains could result in an unacceptable Risk if it went unattended. Example 1: If Essential Performance is lost because of an interruption of the Supply Mains an Alarm System intended to notify the Operator that the Supply Mains has been interrupted would need to have a backup power source so that the generation of the Alarm Signal would not depend on the Supply Mains 7.8 * Indicator lights and controls, 7.8.1 Colors of indicator lights - The colors of indicator lights and their meanings shall comply with Table 2. NOTE: IEC 60601-1-8 contains specific requirement for the color, flashing frequency and Duty Cycle of alarm indicator lights. Dot-matrix and other alphanumeric displays are not considered to be indicator lights Table 2 – Colors of indicator lights and their meaning for ME Equipment: 9.6.2.1 Audible acoustic energy In Normal Use - The Patient, Operator and other persons shall not be exposed to acoustic energy from ME Equipment, except sound from auditory Alarm Signals, exceeding the levels specified below. – 80 dB(A) for a cumulative exposure of 24 h over a 24 h period; an offset of 3 dB(A) is to be added to this value when halving the cumulative exposure time over a 24 h period (e.g. 83 dB(A) for 12 h over a 24 h period); – 140 dB dB(C) (peak) sound pressure level for impulsive or impact acoustic energy (noise). NOTE 1: Interpolation or extrapolation is allowed for exposure times in accordance with the following formula, 80 - 10* log (h/24), in dB(A), where h is cumulative exposure time over a 24 h period 10 NOTE 2: Since Patients might have a higher sensitivity to acoustic energy (noise), a lower level could be more appropriate. Consideration should also be given to perception of auditory Alarm Signals. The World Health Organization has recommended a maximum impulse or impact acoustic energy (noise) level for children of 120 dB NOTE 3: If the A-weighted sound pressure level exceeds 80 dB(A), noise protection measure should be considered. Compliance is checked by measuring the maximum A-weighted sound pressure level at the minimum distances of Patient, Operator and other persons from the source of acoustic energy (noise) in Normal Use, and if necessary, calculating the A- weighted sound pressure level produced by the ME Equipment in accordance with ISO 3746, ISO 9614-1 or IEC 61672-1. The following conditions apply. a) The ME Equipment is operated under worst-case Normal Condition. b) Any protective means provided or called for in Accompanying Documents are to be in place during sound measurement. c) Sound level meters used in the measurement conform to IEC 61672-1 and IEC 61672-2. d) The test room is semi-reverberant with a hard reflecting floor. The distance between any wall or other object and the surface of the ME Equipment is not less than 3 m. e) When sound measurements in a test room are not feasible (e.g. for a large Permanently Installed Equipment), measurements may be done in situ 12.3 Alarm Systems - If the Manufacturer has implemented an Alarm System, this Alarm System shall comply with IEC 60601-1-8. Compliance is checked as specified in IEC 60601-1-8 12.4.4 Incorrect output - When applicable, the Manufacturer shall address in the Risk Management Process the Risks associated with incorrect output. Example: The Risks associated with incorrect delivery of energy or substances to a Patient can be addressed by providing an Alarm Signal to alert the Operator to any significant departure from the set level of delivery Compliance is checked by inspection of the Risk Management File Subclause 7.8 – Indicator lights and controls - For colors of indicator lights see also IEC 60073 [5]. Color alone should not be used to convey important information. A redundant means of conveying information such as shape, location, sound or marking is recommended. Subclause 11.8 – * Interruption of the power supply /Supply Mains to ME Equipment Interruption of the power supply could result in a Hazardous Situation due to loss of functionality. This Hazardous Situation is dealt with in 7.9.2.4. Restoration of the power source can also result in Hazardous Situations. Example: Examples could include unintended activation of moving parts or resumption of dangerous outputs. These potentially Hazardous Situation and the duration of the power interruption that could result in the Hazardous Situations need to be considered as part of the Risk Management Process. IEC 61000-4-11 [21] defines general and reproducible conditions for the operation of electrical and electronic equipment if they undergo voltage dips, short interruptions and voltage variations. The voltage level and duration of short interruptions are defined in Tables 210 and 211 of IEC 60601-1-2:2001. IEC 60601-1-2 treats these short interruptions as a Normal Condition. For ME Equipment in which the safety of the Patient depends on the continuity of the power, particular standards should include requirements regarding power failure Alarm Signals or other precautions IEC 60601-1-2 Third edition 2007-03 Collateral standard: Electromagnetic Compatibility – Requirements and tests Definition 3.11 – Function- clinically significant operation that the ME Equipment or ME System is intended to perform in the diagnosis, treatment or monitoring of a Patient or for compensation or alleviation of disease, injury or disability. Example: The following are examples of the Functions of ME Equipment or an ME System. – The Functions of a heart-rate monitor include measurement and display of heart rate, and may additionally include audible and visual Alarm Signals and display of the ECG waveform 6.2.1.8 - If a Function associated with Essential Performance (e.g. High Priority and Medium Priority Alarm Conditions) cannot normally be observed or verified during the test, a method shall be provided (e.g. display of internal parameters) for determining compliance. The use of special software or hardware may be needed. 6.2.1.10 - Under the test conditions specified in 6.2, the ME Equipment or ME System shall be able to provide the Basic Safety and Essential Performance. The following Degradations, if associated with Basic Safety and Essential Performance, shall not be allowed: – False Alarms; – cessation or interruption of any intended operation, even if accompanied by an Alarm Signal; – initiation of any unintended operation, including unintended or uncontrolled motion, even if accompanied by an Alarm Signal; – failure of automatic diagnosis or treatment ME Equipment and ME Systems to diagnose or treat, even if accompanied by an Alarm Signal. Subclause 6.2.7.1 b) – ME Equipment and ME Systems are allowed a deviation. For Life-Supporting ME Equipment and ME Systems for which an Alarm System is required, it is likely that the Alarm System will need to be powered by stored energy during power interruptions. A test should be performed to verify that sufficient stored energy is available to operate this Alarm System for an extended period of time, e.g. 5 min or as may be specified in particular standards (IEC 60601-2-X). IEC 60601-1-6 Edition 3.0 2010-01 General requirements for Basic Safety and Essential Performance – Collateral Standard: Usability 6.1 * Safety for the Patient, Operator and other persons - A Usability Engineering Process shall be conducted to provide safety for the Patient, Operator and other persons related to Usability of the Operator-Equipment Interface. NOTE 3: The following are examples of Hazards for the Operator: - loud noise emanating from the ME Equipment resulting in hearing impairment Operator-Equipment Interface - The Operator-Equipment Interface includes all means of communication between the ME Equipment to the Operator and the Operator to the ME Equipment. These means include, but are not limited to: Alarm Signals A.2 Rationale for particular clauses and subclauses - Definition 3.4 –The Operator-Equipment Interface includes all means of communication between the ME Equipment to the Operator and the Operator to the ME Equipment. These means include, but are not limited to: – Alarm Signals Definition 3.6 – Primary Operating Function - For the purposes of this collateral standard, a Primary Operating Function is a function that is directly related to the Basic Safety or Essential Performance of the ME Equipment in Normal Use or a function that is frequently used. Example: Examples of Primary Operating Function that directly relate to Basic Safety or Essential Performance include: – inactivating an Alarm Signal (temporarily or indefinitely); – setting Alarm Limits C.2 Use Errors – Operator fails to detect a dangerous increase in heart rate because the Alarm Limit is mistakenly set too high and Operator is over-reliant on Alarm System. C.3 Abnormal Use - The following are abbreviated descriptions of events that occurred despite proper Accompanying Documents, proper design, and proper Training, and were determined to be beyond any reasonable means of Risk Control by the Manufacturer. – Operator inactivates the Alarm System and does not properly monitor the condition of the Patient, preventing detection of the deterioration of the Patient. – Ventilator Alarm System is intentionally disconnected, preventing detection of hazardous condition. The following are examples of detailed Operator-Equipment Interface design requirements.– The ME Equipment shall be capable of producing an auditory Alarm Signal with a sound pressure level adjustable over the range of 45 dB(A) to 80 dB(A) as measured 1 m in front of the ME Equipment. IEC 60601-1-11 Edition 1.0 2010-04 Requirements for Medical Electrical Equipment and Medical Electrical Systems used in the Home Healthcare Environment General Note: Edition 2.0 has been submitted for review, but has not been published yet. 7.4.6 Additional requirements for ME Equipment – Messages In addition to the requirements of 7.9.2.10 of the general standard, the instructions for use shall include a troubleshooting guide for use when there are indications of a ME Equipment malfunction during start-up or operation. The troubleshooting guide shall disclose the necessary steps to be taken in the event of an Alarm Condition. NOTE: See also IEC 60601-1-8 Compliance is checked by inspection of the instructions for use 7.4.10 Additional requirements for ME Equipment and ME Systems - For ME Equipment or an ME System utilizing a Distributed Alarm System - The instructions for use shall include the recommended placement of the remote parts of the Distributed Alarm System to ensure that an Operator can be notified at all times by an appropriate element of the Distributed Alarm System within its specified range. 8.4 Additional requirements for interruption of the power supply/Supply Mains to ME Equipment and ME System - If an Internal Electrical Power Source is not used, the Life-Supporting ME Equipment or ME System shall be equipped with an Alarm System that includes at least a Medium Priority Alarm Condition that indicates a power supply failure. If an Internal Electrical Power Source is used, the Life-Supporting ME Equipment or ME System shall be equipped with an automatic switchover to the Internal Electrical Power Source and an Alarm System that includes at least a Low Priority Alarm Condition that indicates the switchover to the Internal Electrical Power Source. If an Internal Electrical Power Source is used, the Life Supporting ME Equipment or ME System shall be equipped with an Alarm System that includes at least a Medium Priority Technical Alarm Condition that indicates that the Internal Electrical Power Source is nearing insufficient remaining power for ME Equipment or ME System operation. This Technical Alarm Condition shall provide for a sufficient time or for a sufficient number of procedures for a Lay Operator to act. A Technical Alarm Condition of at least Low Priority shall remain active until the Internal Electrical Power Source is returned to a level that is above the Alarm Limit or until it is depleted. It shall not be possible to inactivate the visual Alarm Signal of this Technical Alarm Condition. 13 Additional requirements for Alarm Systems of ME Equipment and ME Systems - IEC 60601-1-8:2006 applies except as follows: 13.1 * Additional requirement for generation of Alarm Signals - Notwithstanding the requirements of 6.3.1 of IEC 60601-1-8:2006, for the Alarm System of ME Equipment and ME Systems intended for the Home Healthcare Environment, unless they are connected to a Distributed Alarm System that includes the generation of auditory Alarm Signals as specified in IEC 60601-1-8:2006, each High Priority and Medium Priority Alarm Condition shall cause the generation of auditory Alarm Signals as specified in IEC 60601-1- 8:2006. 13.2 * Additional requirement for Alarm Signal volume - Notwithstanding the requirements of 6.3.3.2 of IEC 60601-1-8:2006, for the Alarm System of ME Equipment and ME Systems intended for the Home Healthcare Environment reducing the auditory Alarm Signal volume below audible levels shall: • activate the indication of Alarm Off or Audio Off as specified in IEC 60601-1-8:2006. • for Life-Supporting ME Equipment or ME System not be possible unless the Alarm System is connected to a Distributed Alarm System that includes the generation of auditory Alarm Signals as specified in IEC 60601-1-8:2006. NOTE: Guidance on suitable auditory Alarm Signal volumes is found in the rationale for 6.3.3.2 of IEC 60601-1-8:2006 Compliance is checked by functional testing. Many non-Life-Supporting ME Equipment or ME Systems do not need a Technical Alarm Condition that indicates a loss of battery power, since the lack of any displayed output can be an adequate indication of no operation. However, inaccurate output data frequently could be considered as a loss of Essential Performance and would generally require a Technical Alarm Condition. See 8.4 for additional requirements when the safety of the Patient is dependent on continual operation Subclause 13.1 – Additional requirements for generation of Alarm Signals - In the Home Healthcare Environment, auditory Alarm Signals are at least as important as visual Alarm Signals. Alarm Conditions that require either immediate or prompt Operator action to protect the safety of the Patient are required to have an auditory Alarm Signal. That Alarm Signal is permitted to be present either at the ME Equipment or at a Distributed Alarm System. By permitting a Distributed Alarm System to provide the auditory Alarm Signals, this standard permits designs that allow the Patient area to be quiet, e.g. the baby's room, while the Alarm Signals are present where the Operator is located, e.g. the parent's room. Subclause 13.2 – Additional requirements for Alarm Signals volume - Reducing the auditory Alarm Signal volume below audible levels effectively initiates the Alarm Off or Audio Off Alarm Signal Inactive State. This standard requires such an action to indicate that Alarm Signals are inactivated. Such an action is inappropriate for a Life-Supporting Equipment or ME System unless it is connected to a Distributed Alarm System that is capable generating auditory Alarm Signals. IEC 60601-1-12 Ed.1.0 2014 Requirements for Medical Electrical Equipment and Medical Electrical systems intended for use in the Emergency Medical Services Environment 6.3.5 Additional requirements for ME Equipment messages - In addition to the requirements of 7.9.2.10 of the general standard, the instructions for use shall include a troubleshooting guide for use when there are indications of a ME Equipment malfunction during start-up or operation. The troubleshooting guide shall disclose the necessary steps to be taken in the event of each Technical Alarm Condition. NOTE: See also IEC 60601-1-8. Compliance is checked by inspection of the instructions for use 8.2 Additional requirements for interruption of the power supply to ME Equipment and ME System NOTE 1: For most ME Equipment or ME Systems, Essential Performance is providing an intended clinical function within specified limits or alerting the Operator of the loss or degradation of that function with an Alarm Signal. If an Internal Electrical Power Source is not provided, ME Equipment or ME Systems with Essential Performance intended to actively keep alive or resuscitate a Patient shall be equipped with an Alarm System that includes at least a Medium Priority Alarm Condition that indicates a power supply failure. Example 2: The Supply Mains voltage falls below the minimum value required for normal operation If an Internal Electrical Power Source is used, the ME Equipment or ME System with Essential Performance intended to actively keep alive or resuscitate a Patient shall be equipped with an Alarm System that includes at least a Medium Priority Technical Alarm Condition that indicates that the Internal Electrical Power Source is nearing insufficient remaining power for ME Equipment operation. This Technical Alarm Condition shall provide for a sufficient time or for a sufficient number of Procedures for an Operator to act. A Technical Alarm Condition of at least Low Priority shall remain active until the Internal Electrical Power Source is returned to a level that is above the Alarm Limit or until it is depleted. It shall not be possible to inactivate the visual Alarm Signal of this Technical Alarm Condition. Compliance is checked by inspection, functional testing and inspection of the Risk Management File Subclause 6.3 – Instructions for use - Space is limited in ambulances and frequently the full instructions for use are not stored in the ambulance, but in the facility where the ambulance is stationed. The Manufacturer of ME Equipment intended for the EMS Environment should consider creating shortened instructions for use that contains the most essential operating instructions. These shortened instructions for use are more likely to follow the equipment into the ambulance. The information in these shortened instructions for use should include items such as the start-up Procedure, the most common operating instruction and controls for any Alarm Systems. Additionally, troubleshooting instructions and, if applicable, altitude compensation tables should be included.