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IEC 60601-1
Medical Equipment Compliance
Certification and Regulatory
Help Site

 

IEC 60601-1 Standards Information

This is the MECA help website.
Also see our main site at
60601-1.com.


Introduction

This information is provided to help you understand why you need to meet the medical standards, the process of evaluating and documenting compliance, and steps you can take to meet the requirements. We will provide tips to use in the design process and when creating the required documentation, as well as how to avoid common mistakes.


What are the standards used for and why do I need to meet them?

 

Medical devices/equipment is held to a higher level of safety than almost all other types of equipment on the market.

There are several reasons for this: medical equipment may be used on patients who are not able to respond to hazardous conditions or pain, an actual electrical connection between the equipment and patient may exist, and certain types of medical equipment function as life support so their failure could result in the patient’s death. The medical equipment basic safety and essential performance standards were written to take this into account, so their requirements impact your entire design and documentation process.

 

The internationally harmonized electrical medical equipment standards are written by the IEC (International Electrotechnical Commission), which is made up of representatives from participating countries. The process takes several years and is voted on by the participating countries to be published and accepted. These standards are then either adopted by countries as the IEC standard or harmonized into a national published standard with or without deviations; such as in the US, Canada, and the European Union. Deviations mainly address the differences in national electric codes in the different countries.

 

The standards for “Medical Electrical Equipment”, which includes all electrically powered equipment (even if it’s battery operated), is the IEC 60601-1 family of standards. This includes the IEC 60601-1 Base standard and the National Deviations: AAMI ES 60601-1 (US), CSA C22.2 No. 60601-1 (Canada), and EN 60601-1 (European Union). Note that UL no longer publishes the US version of this standard, which was UL 60601-1, based on
IEC 60601-1 Edition 2. There are also IEC 60601-X-XX “Collateral” standards and “Particular” standards that must be used, when applicable.
The IEC 60601-1-XX Collateral standards cover a so-called technology or specific applications. This includes IEC 60601-1-2 (EMC - electromagnetic compatibility), IEC 60601-1-6 (Usability), and IEC 60601-1-8 (Alarms), to name a few. The IEC 60601-2-XX Particular standards cover specific device types. There are currently over 60, including IEC 60601-2-2 (Electrosurgical equipment), IEC 60601-2-24 (Infusion Pumps), IEC 60601-2-27 (ECG monitors), and IEC 60601-2-52 (Medical beds), to name a few. The ISO 80601-2-XX standards differ from the IEC 60601-2-XX standards, in that they were written either jointly by the ISO and IEC standards writing organizations, or by ISO alone. You can see a list of all of these standards on the
MECA download page (Medical Standards List with Publish Dates).

 

All of these applicable standards are used to show your device is safe and meets essential performance for global compliance. They define the broadly acceptable (minimum) level of risk and are used as a tool for the fulfilment of regulatory burden to place your device on the market internationally.

 

 

Medical Standards History: Editions, Amendments, and Corrigendums

 

The following list provides the history of the US and internationally harmonized medical standards.
This does not include the Collateral or Particular standards, for use with IEC 60601-1 (see above for a link to that list).

1972 (US), UL (Underwriters Laboratories) published the UL 544 standard for medical and dental equipment (new standard)

1977, IEC 601-1, Edition 1 published for medical equipment (new standard)

- (Note, the additional “60” was added to the front of the IEC standards in the late 1990s)

1988, Amendment 1 to IEC 601-1, Edition 1 published (minor technical revisions)

1988, IEC 601-1, Edition 2 published (revised standard)

1991, Amendment 1 to IEC 601-1, Edition 2 published (minor technical revisions)

1994 (US), UL 2601-1, Edition 1 standard published (harmonized with IEC 60601-1, Edition 2 + Amendment 1 + US Deviations)

1995, Amendment 2 to IEC 601-1 (now IEC 60601-1), Edition 2 published (minor technical changes)

1997 (US), UL 2601-1, Edition 2 standard published (adding Amendment 2 of IEC 60601-1)

2003 (US), UL 60601-1, Edition 1 standard published (editorial changes only)

2005, IEC 60601-1, Edition 3 published (Completely revised standard)

2005 (US), AAMI published the AAMI ES 60601-1 standard (harmonized with IEC 60601-1, Edition 3 + US Deviations)

2006, Corrigendum 1 to IEC 60601-1, Edition 3 published (corrections to standard)

2007, Corrigendum 2 to IEC 60601-1, Edition 3 published (corrections to standard)

2008, IS1 to IEC 60601-1, Edition 3 published (interpretations to standard)

2009, IS2 to IEC 60601-1, Edition 3 published (interpretations to standard)

2012, Amendment 1 to IEC 60601-1, Edition 3 published, re-named Edition 3.1 (major corrections to standard)

2012 (US), ES 60601-1:2005(R)2012 published (harmonized with IEC 60601-1, Edition 3 with Amendment 1 – Edition 3.1)

2013, IS3 to IEC 60601-1, Edition 3.1 published (interpretations to standard)

2014, Corrigendum 1 to IEC 60601-1, Edition 3.1 published (corrections to standard)

Proposed:
2018, Amendment 2 to IEC 60601-1, Edition 3 published (critical errors corrected)

2024, IEC 60601-1, Edition 4 published (all corrections addressed)


Continued on the next page: Country Requirements