The big news in the IEC 60601-1, 3rd ed. world today is the US National Standard that is in the FDA’s Recognized Consensus Standards Lists [Now is ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) – Recognition List #: 031, Recognition # 5-77] has had it’s transition date moved from June 30, 2013 to December 31, 2013. So, if you are about to submit to the FDA for a pre-market submission you still may have a choice to use the IEC 60601-1, 2nd edition version of the standard instead of the US National Version of IEC 60601-1, 3rd ed. You still may want to use the US National Version that is based on IEC 60601-1, 3rd ed. but now you have a choice again. So, as of January 1, 2014 all your pre-market submissions to the FDA that rely on the US National version of the IEC 60601-1, 3rd ed. standard should be using this version of the standard (ANSI/AAMI ES60601-1:2005/(R)2012…, Rec List #: 031, Rec #: 5-77). Note, that use of the FDA’s Recognized Consensus Standards is voluntary but if you don’t use it realize the burden of proof is higher on your shoulders to prove to the FDA you meet the requirements they are expecting from you.
From what I have determined the change in transition date is based on that OSHA’s NRTL (Nationally Recognized Test Laboratories) Program will be aligning with the FDA in terms of this standard and will hopefully be by the end of this year, if not sooner, they will be able to approve NRTL Test Labs to the US National Version of IEC 60601-1, 3rd ed. which probably will be ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text). FDA has been intending to, and I hope they do, come out with a guidance document for premarket submissions of medical electrical equipment and what their expectations are for applying the US National Version of IEC 60601-1, 3rd edition. Also, about 1-1/2 months ago FDA announced their concern about cyber-security for medical devices and hospital networks and so they issued a Safety Communication on June 13, 2013 to medical device manufacturers, hospitals, medical device user facilities, health care IT & procurements staff; & biomedical engineers; and they issued a draft guidance document on the issue on June 14, 2013. To coordinate all these activities, draft guidance documents, and agencies FDA decided to extend the transition period for the US National version of IEC 60601-1, 3rd ed. equivalent.
The IEC 60601 series of standards that FDA has Listed in the Recognized Consensus Standards Listing and some of the ISO 80601 series of standards that FDA has listed are updated in List 031 with this new transition date, unless it is a brand new standard being published on the List for the first time, along with other changes that were ready to be published. The Cyber-security standards are listed in Recognition List 032 and are all new listings to the List of Recognized Consensus Standards. There were many other changes with these Recognition Lists 031 & 032 which will officially be published in the Federal Register as of 6 August 2013 and the changes will officially be effective then but have already been issued prior to August 6, 2013 in the FDA’s Recognized Consensus Database. (Either one or two days prior).
Below is a summary of the more critical changes, from my perspective, for List 031.
New Standards Added to the FDA’s Recognition List 031 (Table 2 of List 031) of significance are:
Recognition Number | Title of Standard (Abbreviated) | Standard Ref Number / Date of Issue | Blog Comments |
5-75 | Medical devices–Symbols to be used w/ med dvc labels, labeling, & info to be supplied–Part 1 | ANSI/AAMI/ISO 15223-1 / 2012 | Added the US National Version in addition to the ISO version which is Recognition # 5-73 |
17-11 | Med electrical equip–Part 2-10: Particular requirements for basic safety & essential performance of nerve & muscle stimulators | IEC 60601-2-10 Edition 2.0 / 2012-06 | Newer version of std. Transition date set for Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 17-5, IEC 60601-2-10:1987 + Amendment 1 2001 accepted up til Dec 31, 2013. Note, the transition date info is not mentioned in Rec # 17-5. |
12-251 | Med elect equip–Part 2-63: Particular requirements for basic safety & essential performance of dental extra-oral X-ray equipment | IEC 60601-2-63 Edition 1.0 / 2012-09 | Brand new std added to Recognized Consensus Standards. Since there isn’t a previous ver. of the std there is no transition date. This means this std is effective on the date of publication of this Listing in the Federal Register which is 6 August 2013. |
12-252 | Med elect equip–Part 2-65: Particular requirements for basic safety & essential performance of dental intra-oral X-ray equipment | IEC 60601-2-65 Edition 1.0 / 2012-09 | Same comments as above Rec. # 12-251. |
There were also modifications to the List of Recognized Stds (Table 1 of List 031) of some importance. The 60601 related standards were updated to align with the transition period of ANSI/AAMI ES60601-1 std along with other changes of importance as noted below.
Recognition Number(New) | Title of Standard (Abbreviated) | Standard Ref Number / Date of Issue | Blog Comments |
1-82 | Med electrical equip–Part 2-13: Particular requirements for basic safety & essential performance of anaesthetic systems | IEC 60601-2-13 Edition 3.1 / 2009-08 | Newer version of std. Transition date set for Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 1-61, IEC 60601-2-13:2003-05 accepted up til Dec 31, 2013. |
1-88 | Med electrical equip–Part 2-12: Particular requirements for basic safety & essential performance of lung ventilators — Critical care ventilators | ISO 80601-2-12 First Edition / 2011-04-15 | Newer version of std (previously was an IEC std and now an ISO std as it was done by a Joint Working group of IEC & ISO committee members). Transition date set for Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 1-60, IEC 60601-2-12:2001-10 accepted up til Dec 31, 2013. |
2-198 | Biological eval of med dvcs–Part 12: Sample prep & ref mat’ls | ANSI/AAMI/ISO 10993 / 12:2012 | Newer US National Version of ISO 10993-12. Withdrawn the ANSI/AAMI/ISO 10993-12:2007 version of the std, Rec. # 2-135 |
2-174(Published 03/16/2012) | Biological eval of med dvcs—Part 10: Tests for irritation & skin sensitization | ISO 10993-10 Third Edition / 2010-08-01 | Withdrew older version of ISO version of the std. Refer to Rec. # 2-152, ISO 10993-10: 2002 / Amendment 1:2006 |
3-115 | Med electrical equip–Part 2-34: Particular requirements for basic safety & essential performance of Invasive Blood Pressure Monitoring Euip | IEC 60601-2-34 Edition 3.0 / 2011-05 | Newer version of std. Transition date set for Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 3-38, IEC 60601-2-34:2000-10 accepted up til Dec 31, 2013 but it’s Rec # 3-38 has been deleted from the FDA Database. |
4-187 | Med electrical equip–Part 2-18: Particular requirements for basic safety & essential performance of endoscopic equip | IEC 60601-2-18 Edition 3.0 / 2009-08 | FDA’s notice says transition period extended but when checked the database the transition period ended June 30, 2013 and is referring only to IEC 60601-1:2001 (Edition 2) and ANSI / AAMI ES60601-1:2005 which doesn’t correlate with the other listings. It seems like the database either hasn’t been updated for this item or got goofed up as of the evening of Aug 5th. |
5-53 | Med electrical equip – Part 1-2: General requirements for basic safety & essential performance – Collateral std: Electromagnetic compat – Requirements & tests | IEC 60601-1-2 Edition 3.0 / 2007-03 | Transition period extended for this IEC version of the std from June 30, 2013 to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 5-34, IEC 60601-1-2, Edition 2:2001 + Amendment 1:2004 accepted up til Dec 31, 2013. |
5-54 | Med electrical equip – Part 1-2: General requirements for basic safety & essential performance – Collateral std: Electromagnetic compat – Requirements & tests | ANSI/AAMI/IEC 60601-1-2 Edition 3.0 / 2007 (R)2012 | Transition period extended for US National version (ANSI/AAMI/IEC) of the std from June 30, 2013 to Dec 31, 2013 and this std reaffirmed in 2012. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 5-35, ANSI/AAMI/IEC 60601-1-2, Edition 2:2001 + Amendment 1:2004 accepted up til Dec 31, 2013. |
5-76 | Med electrical equip – Part 1-8: General requirements for basic safety & essential performance – Collateral std: General requirements, tests, & guidance for alarm systems in med elect equip & med elect systems | IEC 60601-1-8 Edition 2.1 / 2012-11 | Withdrew Rec # 5-55 (IEC 60601-1-8 Ed.1:2003) and replaced with Rec #5-76 and extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 5-55 accepted up til Dec 31, 2013. |
6-300 | Med electrical equip–Part 2-21: Particular requirements for basic safety & essential performance of infant radiant warmers | IEC 60601-2-21 Edition 2.0 / 2009-02 | Rec #6-300 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 6-9 (IEC 60601-2-21:1996 + A1:2000) accepted up til Dec 31, 2013. In the extension note section of Rec # 6-300 there are a couple typos as they refer to 60601-2-19 instead of 60601-2-21. |
6-298 | Med electrical equip–Part 2-19: Particular requirements for basic safety & essential performance of infant incubators | IEC 60601-2-19 Edition 2.0 / 2009-02 | Rec #6-298 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 6-29 (IEC 60601-2-19 A1:1996-10) accepted up til Dec 31, 2013. In the extension note section of Rec # 6-298 there are a couple typos as they refer to ANSI/AAMI/IEC 60601-2-19:2009 instead of IEC60601-2-19:2009-02 |
6-299 | Med electrical equip–Part 2-20: Particular requirements for basic safety & essential performance of infant radiant warmers | IEC 60601-2-20 Edition 2.0 / 2009-02 | Rec #6-299 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 6-32 (IEC 60601-2-20 A1:1996-10) accepted up til Dec 31, 2013. In the extension note section of Rec # 6-299 there are a couple typos as they refer to ANSI/AAMI/IEC 60601-2-19:2009 instead of IEC60601-2-20:2009-02 |
6-227 | Medical electrical equipment–Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers | ANSI/AAMI/IEC 60601-2-21 / 2009 | Rec #6-227 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 6-146 (IEC 60601-2-21:1996 + A1:2000) accepted up til Dec 31, 2013. |
6-228 | Medical Electrical Equipment–Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | IEC 60601-2-2 Edition 5.0 / 2009-02 | Rec #6-228 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 9-46 (IEC 60601-2-2:2006) accepted up til Dec 31, 2013. |
6-229 | Medical electrical equipment–Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories | ANSI/AAMI/IEC 60601-2-2 / 2009 | Rec #6-229 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 9-46 (IEC 60601-2-2:2006) accepted up til Dec 31, 2013. |
6-230 | Medical Electrical Equipment–Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | ANSI/AAMI/IEC 60601-2-19 / 2009 | Rec #6-230 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 6-29 (IEC 60601-2-19 A1:1996-10) accepted up til Dec 31, 2013. |
6-231 | Medical Electrical Equipment–Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators | ANSI/AAMI/IEC 60601-2-20 / 2009 | Rec #6-231 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 6-32 (IEC 60601-2-20 A1:1996-10) accepted up til Dec 31, 2013. |
6-233 | Medical electrical equipment — Part 2-52: Particular requirements for basic safety and essential performance of medical beds | IEC 60601-2-52 Edition 1.0 / 2009-12 | Rec #6-233 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 6-182 (IEC 60601-2-38:1996 + A1:1999) accepted up til Dec 31, 2013. |
6-234 | Medical electrical equipment–Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment | IEC 60601-2-50 Edition 2.0 / 2009-03 | Change in contact person only. |
6-235 | Medical Electrical Equipment–Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment | ANSI/AAMI/IEC 60601-2-50 / 2009 | Same as above comment. |
9-80 | Medical electrical equipment — Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration | IEC 60601-2-16 Third edition / 2008 | Withdrew Rec # 9-60 [IEC 60601-2-16 Edition 3.0 2008-04] and Rec # 9-63 [IEC 60601-2-16 (Third edition–2008)] replaced with Rec #9-80 and extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 9-60 & 9-63 accepted up til Dec 31, 2013. |
9-61 | Medical electrical equipment–Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment | IEC 60601-2-18 Edition 3.0 / 2009-08 | Rec #9-61 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 9-42 (IEC 60601-2-18:1996 + A1:2000) accepted up til Dec 31, 2013. |
9-81 | Medical electrical equipment–Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment | ANSI/AAMI/ IEC 60601-2-16 / 2012 | Rec #9-81 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 9-72 (IEC 60601-2-16:1998) accepted up til Dec 31, 2013. |
9-62 | Medical electrical equipment–Part 2-2: Particular requirements for the basic safety and essential performance of frequencysurgical equipment and high frequency surgical accessories | IEC 60601-2-2 Edition 5.0 / 2009-02 | Rec #9-62 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 9-46 (IEC 60601-2-2:2006) accepted up til Dec 31, 2013. |
9-64 | Medical electrical equipment–Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories | ANSI/AAMI/IEC 60601-2-2 / 2009 | Rec #9-64 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 9-46 (IEC 60601-2-2:2006) accepted up til Dec 31, 2013. |
12-201 | Medical electrical equipment–Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | IEC 60601-2-54 Edition 1.0 / 2009-06 | Rec # 12-201 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-34 (IEC 60601-2-7 Second Edition 1998-02) & Rec # 12-127 (IEC 60601-2-32 Edition 1.0 1994) accepted up til Dec 31, 2013. |
12-254 | Medical electrical equipment–Part 2-8: Particular requirements for the basic safety and essential performance of therapeuticX-ray equipment operating in the range 10 kV to 1 MV | IEC 60601-2-8 Edition 2.0 / 2010-11 | Rec # 12-254 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-54 (IEC 60601-2-8 1999-04) accepted up til Dec 31, 2013. |
12-255 | Medical electrical equipment–Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment | IEC 60601-2-11 Edition 3.0 / 2013-01 | Rec # 12-255 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-133 (IEC 60601-2-11:1997 + A1:2004) accepted up til Dec 31, 2013. |
12-202 | Medical electrical equipment–Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventionalprocedures | IEC 60601-2-43 Edition 2.0 / 2010-03 | Rec # 12-202 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-63 (IEC 60601-2-43 Edition 1.0 2000) accepted up til Dec 31, 2013. |
12-256 | Medical electrical equipment–Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computedtomography | IEC 60601-2-44 Edition 3.1 / 2012-09 | Rec # 12-254 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-203 or 12-120 (IEC 60601-2-44 2002-11) accepted up til Dec 31, 2013. Not clear if one or both are applicable. |
12-204 | Medical electrical equipment–Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis | IEC 60601-2-28 Edition 2.0 / 2010-03 | Rec # 12-204 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-126 (IEC 60601-2-28 Edition 1.0 1993) accepted up til Dec 31, 2013. |
12-205 | Medical electricalequipment–Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonicphysiotherapy equipment | IEC 60601-2-5 Edition 3.0 / 2009-07 | Rec # 12-205 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-147 (IEC 60601-2-5 Edition 2.0 2000) accepted up til Dec 31, 2013. |
12-206 | Medical electricalequipment–Part 2-1: Particular requirements for the basic safety and essential performance of electronaccelerators in the range 1 MeV to 50 MeV | IEC 60601-2-1 Edition 3.0 / 2009-10 | Rec # 12-206 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-152 (IEC 60601-2-1 1998 + A1:2002) accepted up til Dec 31, 2013. |
12-207 | Medical electrical equipment–Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic | IEC 60601-2-33 Edition 3.0 / 2010-03 | Rec # 12-207 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-189 (IEC 60601-2-33 Edition 2.2 2008) accepted up til Dec 31, 2013. |
12-208 | Medical electrical equipment–Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic anddiagnostic laser equipment | IEC 60601-2-22 Third Edition / 2007-05 | Rec # 12-208 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-197 (IEC 60601-2-22 Edition 2.0 1995) accepted up til Dec 31, 2013. |
12-209 | Medical electrical equipment–Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | IEC 60601-2-37 Edition 2.0 / 2007-08 | Rec # 12-209 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-198 (IEC 60601-2-37:2004 + A2:2005) accepted up til Dec 31, 2013. |
12-210 | Medical electricalequipment–Part 1-3: General requirements for basic safety and essential performance–Collateral Standard: Radiation protection in diagnostic X-ray equipment | IEC 60601-1-3 Edition 2.0 / 2008-01 | Rec # 12-210 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-199 (IEC 60601-1-3 1994) accepted up til Dec 31, 2013. |
12-211 | Medical electrical equipment Part 2-29: Particular requirements for the basic safety and essential performance ofradiotherapy simulators | IEC 60601-2-29 Edition 3.0 / 2008-06 | Rec # 12-211 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-200 (IEC 60601-2-29 Edition 2.0 1999) accepted up til Dec 31, 2013. |
12-256 | Medical electrical equipment–Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CORRIGENDUM 1 | IEC 60601-2-44 Third edition / 2009 | Withdrew Rec # 12-224 [IEC 60601-2-2-44 2002-11] and Rec # 12-250 [IEC 60601-2-2-44 2002-11] replaced with Rec #12-256 and extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-224 &12-250 accepted up til Dec 31, 2013. Unable to totally confirm that Rec #’s 12-224 & 12-250are linked to IEC 60601-2-44 2002-11]. |
12-236 | Medical electrical equipment–Part 2-45: Particular requirements for the safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices | IEC 60601-2-45 Edition 3.0 / 2011-02 | Rec # 12-236 extended transition period to Dec 31, 2013. So, on Jan 1, 2014 this ver. of the std will only be accepted. Rec # 12-178 (IEC 60601-2-45 Edition 2.0 2001) accepted up til Dec 31, 2013. |
In a future blog post we may discuss Recognition List 032 and the Cyber-security standards.
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