New requirements - Amendment 1 of IEC 60601-1 3rd edition
IEC/EN 60601-1 Ed.3.1: Basic Safety and Essential Performance.
The IEC 60601-1 is the General Overview document for the IEC 60601 Series. It has been adopted
around the world over as the benchmark for the import of medical devices. The General Medical Standard
contains requirements concerning basic safety and essential performance that are generally applicable to
medical electrical equipment. For certain types of medical electrical equipment, these requirements are
either supplemented or modified by the special requirements of a Collateral or Particular Standards.
Where Particular standards exist, the General Standard should not be used alone.
Amendment 1 to IEC 60601-1:2005/EN 60601-1:2006 was released in July 2012 and immediately got
much attention. It is acceptable to use the standard in some markets; many designers and medical device
manufacturers of medical electrical equipment should be aware of the changes and also may use the
changes to justify alternate solutions for improving their products.
*On May 16, 2014 the EU updated EU Official Journal for the Medical Device includes the EN 60601-1 with
Amendment 1. Starting with 1 January 2018, customers using the 60601-1 standard as a presumption of
conformity will need to use the EN 60601-1:2006/A1:2013.
** On November 25, 2013, OSHA published a notice in the Federal Register proposing acceptance of
ANSI/AAMI ES60601-1:2005/(R)2012 Medical electrical equipment, Part 1 including the first amendment.
Since 2014 - OSHA NRTL’s approved for AAMI ES 60601-1 3rd edition + Amendment 1 (or edition 3.1).
There are some basic statistics for Amendment 1 against 3rd edition (IEC 60601-1:2005):
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~260 changes
21 new requirements
63 modifications to requirements/tests
47 cases where risk management was deleted or made optional
19 corrections to requirements or test methods
Major issues:
 Risk management - the general Clause 4.2 defines much clear the use of ISO 14971 for specific
technical issues of IEC 60601-1, such as providing technical criteria for a specific test or justifying
an alternate solution. Full assessment of ISO 14971 is not required, and post market area is
specifically excluded. The standard also clearly states that an audit is not required to determine
compliance. Within the standard, the number of references to risk management has been
reduced, with some cases of simply reverting back to the original 2nd edition requirements.
 Essential performance – was adopted some colossal changes. The manufacturer shall declare
exact performance limits for each essential performance function. It is not enough to say “blood
pump speed” for example – as was in 3rd Edition, 3.1 Edition requires setting specification on:
o range: xx-yy mL per minute
o accuracy: ±xx % or ±xx mL
o arterial pressure: ±xx mmHg
o venous pressure -xx~+yy mmHg
o fluid temperature: xx-yy °C
o etc.
The manufacturer should consider separately essential performance in abnormal or fault
conditions. For example under a hardware fault condition a blood pump may not be expected to
provide flow with 10% accuracy, but it should still confidently stop the blood flow and generate a
high priority alarm. Care is needed, as the definition of a single fault condition includes abnormal
conditions, and many of these conditions occur at higher frequency than faults and therefore and
require a special response. User errors, low batteries, power failure, use outside of specified
ranges are all examples where special responses and risk controls may be required that are
different to genuine fault condition. For example, even a low risk diagnostic device is expected to
stop displaying measurements if the measurement is outside of the rated range or battery is too
low for accurate measurement.
Essential performance must also be declared in the technical description. This is major
change since it forces manufactures to declare essential performance in the commercial
world, especially visible since most manufacturers incorporate the technical description in
the operation manual. Until now, some manufacturers have declared there is no essential
performance, to avoid requirements such as PEMS. But writing “this equipment has no
essential performance” would raise the obvious question … what good is the equipment?
In Edition 3 of the General Standard, the only test clause which requires essential performance
is the defibrillator proof tests. Now, in 3.1 edition, essential performance is mentioned in the
compliance criteria many times in Clauses 9 (Protection against MECHANICAL HAZARDS), 11
(Protection against excessive temperatures and other HAZARDS) and 15 (Construction of ME
EQUIPMENT). These are stress tests including mechanical tests, spillage, sterilization and
cleaning. The good news is that the standard makes it clear that functional tests are only applied
if necessary. So, if engineering judgment says that a particular test is unlikely to affect
performance, there is no need to actually test performance.
 New marking requirements - contact information, serial number and date of manufacture are
now required on the labeling, aligning with EU requirements. The serial number is of special note,
since the marking method is often different to the main label. Accessories are also required to
marked with the same details (contact information, serial number, date of manufacturer). This
also fits with EU requirements, provided that the accessory is placed on the market as a separate
medical device. This may yield an effective differentiation between an “accessory” and a
“detachable part” – accessories are detachable parts which are placed on the market separately.
 Both the instructions for use and the technical description - must have a unique identifier (e.g.
revision number, date of issue).
 For defibrillation tests - any unused connectors must not allow access to defibrillator energy
(effectively requires isolation between different parts/ special connectors).
 Mechanical tests for instability and mobile equipment (rough handling test) were modified.
 The previous 15W/900J exemption of secondary circuits from fire enclosure/fault testing has
been expanded to 100VA/6000J if some special criteria are met (e.g. using PCB with FV1 rating).
Since the criteria are easy to meet, it will greatly expand the areas of the equipment that does
not need a fire enclosure or flame proof wiring; welcome news considering the huge
environmental impact of flame retardants.
 For PEMS - selected references to IEC 62304 are now mandatory (Clauses 4.3, 5, 7, 8 and 9)
I.T.L. has a highly trained team in the medical electrical equipment testing and
certification to IEC 60601-1 for all the major markets.
ITL is an independent test and certification laboratory, accredited to ISO/IEC 17065 and
ISO/IEC 17025. International agencies and institutions that certified ITL include A2LA,
Intertek (ETL), TUV, UL, CSA, FCC, DNV, Industry Canada (IC), Nemko, NATA, “Israeli
Ministry of Economy” and more. ITL is a certification body and test lab under the IECEx
and a CBTL lab under the IECEE CB scheme. ITL is accredited and performs testing,
certification and evaluation in the areas of Safety, EMC, Radio, Telecom, Environmental
and Explosive Environment based on International and local standards.