{"id":3531,"date":"2013-11-21T08:03:19","date_gmt":"2013-11-21T08:03:19","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3531"},"modified":"2013-11-21T08:03:19","modified_gmt":"2013-11-21T08:03:19","slug":"status-update-on-en-60601-106-a113-for-eu-mdd-annexes-za-zz","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/11\/21\/status-update-on-en-60601-106-a113-for-eu-mdd-annexes-za-zz\/","title":{"rendered":"Status Update on EN 60601-1:06 + A1:13 for EU MDD &#038; Annexes ZA &#038; ZZ"},"content":{"rendered":"<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization &amp; Impact of Annex ZA &amp; ZZ are discussed in this blog.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><!--more--><\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">So, you can get to the important areas for you I have split this blog into several sections that you can jump too quickly by clicking on the below links:<\/span><\/p>\n<ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><a href=\"#Whendid60601A1comeout\">When did the IEC 60601-1 A1 come out?<\/a><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><a href=\"#WhatisstatusofEN606011A1\">What is the status of the EN 60601-1 A1?<\/a><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><a href=\"#IsEN606011_A1MDDHarmonized\">Is EN 60601-1:06 + A1:13 Harmonized under the MDD Yet?<\/a><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><a href=\"#AllOtherEN60601SeriesStds\">What about all the other EN 60601 series of standards?<\/a><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><a href=\"#AnnexZA\">So, what is Annex ZA about?<\/a><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><a href=\"#AnnexZZ\">And what about Annex ZZ?<\/a><\/span><\/li>\n<\/ul>\n<\/ul>\n<p><a name=\"Whendid60601A1comeout\"><\/a><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><span style=\"text-decoration: underline;\">When did the IEC 60601-1 A1 come out<\/span>?<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><a href=\"http:\/\/bit.ly\/IEC60601-1A1\" target=\"_blank\" rel=\"noopener noreferrer\">Amendment 1 (A1) of IEC 60601-1:2005 (3<sup>rd<\/sup> ed.)<\/a> was published last summer on 13 July 2013 and the consolidated edition (<a href=\"http:\/\/bit.ly\/ed3dot1IEC60601-1\" target=\"_blank\" rel=\"noopener noreferrer\">edition 3.1 = IEC 60601-1:2005 + A1:2012<\/a>) was published on 20 August 2012.\u00a0 The consolidated edition is very useful as it shows all the <em><span style=\"text-decoration: underline;\">redlines of the 496 changes that were made for A1<\/span><\/em> vs the <a href=\"http:\/\/bit.ly\/3rdedIEC60601-1\" target=\"_blank\" rel=\"noopener noreferrer\">original 3<sup>rd<\/sup> ed<\/a>.<\/span><\/p>\n<p><a name=\"WhatisstatusofEN606011A1\"><\/a><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><span style=\"text-decoration: underline;\">What is the status of the EN 60601-1 A1?<\/span><\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">So, for Europe it has taken over a year to get the EN (European Norm) of <a href=\"http:\/\/bit.ly\/EN60601-1_2006_A1_2013\" target=\"_blank\" rel=\"noopener noreferrer\">A1:2013 to EN 60601-1:2006 (third edition)<\/a> to be ratified by <a href=\"http:\/\/bit.ly\/CENELEC\" target=\"_blank\" rel=\"noopener noreferrer\">CENELEC<\/a> which was on 24 Sept 20013, then it became available for publication (Date of Availability) in Europe on 4 October 2013 and so now it is allowed to be published in Europe and must be implemented or published by all of the EU countries by 24 June 2014.\u00a0 The only country that I have been able to find it published in is Denmark as a Dansk Standard (DS or in English it would be Danish Standards).\u00a0 It is <a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">DS\/EN 60601-1:06\/A1:13<\/a> issued on 15 October 2013.<\/span><\/p>\n<p><a name=\"IsEN606011_A1MDDHarmonized\"><\/a><\/p>\n<p><span style=\"text-decoration: underline; font-size: small; font-family: arial, helvetica, sans-serif;\">Is EN 60601-1:06 + A1:13 Harmonized under the MDD Yet?<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The answer is a no, not yet but we are getting pretty close to it occurring.\u00a0 \u00a0It hasn\u2019t been Harmonized yet but soon it will be approved as a Harmonized Standard.\u00a0 <a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2013\/11\/EN-60601-1_06-+-A1_13-Adoption-of-pilot-Annexes-ZZ-ZA-%E2%80%93-EN-60601-1_06-its-A1-13-BT145_DG9198_DV.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">This document tells a lot of the story for the history of the Harmonization process for EN 60601-1:06 + A1:13<\/a>.\u00a0 This version of the standard has been reviewed and approved for harmonization by the Consultants so its only a matter of publishing it in the <a href=\"http:\/\/bit.ly\/OJ_EU\" target=\"_blank\" rel=\"noopener noreferrer\">Official Journal of the EU (OJ)<\/a>.<\/span><\/p>\n<p><a name=\"AllOtherEN60601SeriesStds\"><\/a><\/p>\n<p><span style=\"text-decoration: underline; font-size: small; font-family: arial, helvetica, sans-serif;\">What about all the other EN 60601 series of standards?<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">If you read thru the <a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2013\/11\/EN-60601-1_06-+-A1_13-Adoption-of-pilot-Annexes-ZZ-ZA-%E2%80%93-EN-60601-1_06-its-A1-13-BT145_DG9198_DV.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">document referenced in the previous paragraph<\/a> you will find there are 41 total 60601 series standards in the pipeline that are all expected to flood out of the <a href=\"http:\/\/bit.ly\/OJ_EU\" target=\"_blank\" rel=\"noopener noreferrer\">OJ<\/a> as <a href=\"http:\/\/bit.ly\/MDD_Harmonized_Stds_Listing\" target=\"_blank\" rel=\"noopener noreferrer\">Harmonized Standards under the MDD<\/a> by the end of the 1<sup>st<\/sup> quarter of 2014.\u00a0 That\u2019s a lot of change to come in a short period of time.\u00a0 But realize that is not the full series of 60601 standard out there &amp; note there are Joint IEC\/ISO projects that are titled 80601 series too.\u00a0 So, keep your eyes and ears peeled and open to keep up with what will be happening soon.<\/span><\/p>\n<p><a name=\"AnnexZA\"><\/a><\/p>\n<p><span style=\"text-decoration: underline; font-size: small; font-family: arial, helvetica, sans-serif;\">So, what is Annex ZA about?<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Annex ZA is a listing of normative (required or mandated) references to international publications with their corresponding European publications.\u00a0 This is a list of the European &amp; <a href=\"http:\/\/bit.ly\/MDD_Harmonized_Stds_Listing\" target=\"_blank\" rel=\"noopener noreferrer\">EU Harmonized standards<\/a>.\u00a0 This primarily changes most of the IEC and ISO standards that are referenced in <a href=\"http:\/\/bit.ly\/ed3dot1IEC60601-1\" target=\"_blank\" rel=\"noopener noreferrer\">IEC 60601-1:06 + A1:13 (ed. 3.1)<\/a> to EN &amp; EN ISO standards for the EN version of the standard.\u00a0 The standards that change in the base of the standard are marked by (mod.) to indicate the original requirements have been modified by common modifications as noted in the beginning of Annex ZA.\u00a0 There are some that stay as IEC &amp; ISO standards but most change.\u00a0 But that isn\u2019t the bombshell.\u00a0 When <a href=\"http:\/\/bit.ly\/IEC60601-1A1\" target=\"_blank\" rel=\"noopener noreferrer\">A1:12 of IEC 60601-1:05<\/a> was published a decision was made to go <em><span style=\"text-decoration: underline;\">from dated references<\/span><\/em> for the IEC 60601 series standards (i.e. <a href=\"http:\/\/bit.ly\/IEC60601-1-2_2007\" target=\"_blank\" rel=\"noopener noreferrer\">IEC 60601-1-2:2007<\/a>) <em><span style=\"text-decoration: underline;\">to primarily undated references<\/span><\/em> (IEC 60601-1-2), unless a specific standard reference didn\u2019t meet the criteria for the change (most changes occurred and a few stayed as dated references).\u00a0 The primary reason for this change was to make the standards development maintenance process of the whole series of standards (almost 60 standards in the series &amp; growing) easier to update when there was a change in a Particular (i.e. IEC 60601-2-XX) or a Collateral standard (i.e. IEC 60601-1-XX).\u00a0 <em><span style=\"text-decoration: underline;\">About a year ago under the IEC A1 version of 60601-1 undated references came about but that now has been changed back to dated references in the EN version of the standard (<a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">EN60601-1:06 +A1:13<\/a>)<\/span><\/em>.\u00a0 <span style=\"text-decoration: underline;\">This means, as it says at the beginning of Annex ZA, \u201cFor dated references, only the (dated) edition cited applies.\u201d<\/span>\u00a0 Annex ZA also says \u201cFor undated references, the latest edition of the referenced document (including any amendments) applies.\u201d<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">So, for the IEC series of 60601 standards you currently have the <a title=\"To learn more about Collateral &amp; Particular Standards read this article\" href=\"http:\/\/bit.ly\/MDDIRegStratsIEC60601-1_3rd\" target=\"_blank\" rel=\"noopener noreferrer\">Collaterals and Particulars<\/a> being updated or will be updated in the near future (now thru about 2 years from now) to reflect the undated standards references to filter through-out the whole series of IEC 60601 standards.\u00a0 So, more change to keep an eye out for.\u00a0 Some people would say you need to have a Master\u2019s degree to keep up with this but you could rely on consultants, like me, as this is one of my many job duties is to keep up-to-date on standards development information so I can keep my client\u2019s informed &amp; up-to-date.<\/span><\/p>\n<p><a name=\"AnnexZZ\"><\/a><\/p>\n<p><span style=\"text-decoration: underline; font-size: small; font-family: arial, helvetica, sans-serif;\">And what about Annex ZZ?<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Annex ZZ is a fairly long section clocking in at 19 pages long and part of the focus is on the Risk Management Process of sub-clause 4.2.2 of <a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">EN 60601-1:06 + A1:13<\/a> as the <a href=\"http:\/\/bit.ly\/DS_EN_ISO14971_2012\" target=\"_blank\" rel=\"noopener noreferrer\">EN ISO 14971:2012<\/a> standard is the Harmonized standard most recently called out in the <a href=\"http:\/\/bit.ly\/MDD_Harmonized_Stds_Listing\" target=\"_blank\" rel=\"noopener noreferrer\">EU MDD Harmonized List of Standards<\/a> (a voluntary listing but easiest way to prove compliance too) and is a significant modification of <a href=\"http:\/\/bit.ly\/ISO14971_2007\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 14971:2007<\/a> with some major changes to it.\u00a0 So read on for more details with respect to the changes for risk management, among other issues for this Annex ZZ.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Annex ZZ is titled the \u201cRelationship between this European Standard and the Essential Requirements of <a href=\"http:\/\/bit.ly\/MDDConsolidated_93_42_EECand2007_47_EC\" target=\"_blank\" rel=\"noopener noreferrer\">EU Directive 93\/42\/EEC on Medical Devices<\/a>\u201d. Annex ZZ is a means for showing conformance to meeting the parts of the Essential Requirements (ER\u2019s), Annex I, of the <a href=\"http:\/\/bit.ly\/MDDConsolidated_93_42_EECand2007_47_EC\" target=\"_blank\" rel=\"noopener noreferrer\">MDD under 93\/42\/EEC as amended by 2007\/47\/EC<\/a>, that apply to the standard <a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">EN 60601-1:06 + A1:13<\/a>.\u00a0 This standard doesn\u2019t confer compliance with all of the ER\u2019s under the MDD only certain ER\u2019s in whole or in part.\u00a0 I am repeating the first page text of Annex ZZ in \u201cquotes\u201d below and then writing my commentary, <em>in italics,<\/em> to explain each section.<\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">\u201cThis European Standard has been prepared under a mandate given to <a href=\"http:\/\/bit.ly\/CENELEC\" target=\"_blank\" rel=\"noopener noreferrer\">CENELEC<\/a> by the European Commission and the <a href=\"http:\/\/bit.ly\/EURO_FTA\" target=\"_blank\" rel=\"noopener noreferrer\">European Free Trade Association<\/a> to provide a means of conforming to the Essential Requirements given in Annex I of the <a href=\"http:\/\/bit.ly\/MDDConsolidated_93_42_EECand2007_47_EC\" target=\"_blank\" rel=\"noopener noreferrer\">EC Directives 93\/42\/EEC as amended by 2007\/47\/EC<\/a>.\u201d<\/span><\/p>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>This means that <a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">EN 60601-1:06 + A1:13<\/a> Annex ZZ will be the means to prove conformance to the ER\u2019s of the MDD in whole or part based on a mandate to <a href=\"http:\/\/bit.ly\/CENELEC\" target=\"_blank\" rel=\"noopener noreferrer\">CENELEC<\/a> from the European Commission &amp; <a href=\"http:\/\/bit.ly\/EURO_FTA\" target=\"_blank\" rel=\"noopener noreferrer\">EFTA<\/a>.<\/em><\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">\u201cOnce this standard will be cited in the <a href=\"http:\/\/bit.ly\/OJ_EU\" target=\"_blank\" rel=\"noopener noreferrer\">Official Journal of the European Union<\/a> under that Directive, compliance with the clauses of this standard given in Table ZZ.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements (ERs) of that Directive and associated <a href=\"http:\/\/bit.ly\/EURO_FTA\" target=\"_blank\" rel=\"noopener noreferrer\">EFTA<\/a> regulations.\u201d<\/span><\/p>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Once this standard is Harmonized under the <a href=\"http:\/\/bit.ly\/MDDConsolidated_93_42_EECand2007_47_EC\" target=\"_blank\" rel=\"noopener noreferrer\">MDD<\/a> (via publication thru the <a href=\"http:\/\/bit.ly\/OJ_EU\" target=\"_blank\" rel=\"noopener noreferrer\">OJEU<\/a>) compliance with the clauses of the standard, within the limits of the scope of the standard, cited in Table ZZ.1 confers a presumption of conformity with the corresponding ER\u2019s of the <a href=\"http:\/\/bit.ly\/MDDConsolidated_93_42_EECand2007_47_EC\" target=\"_blank\" rel=\"noopener noreferrer\">MDD<\/a> &amp; associated <a href=\"http:\/\/bit.ly\/EURO_FTA\" target=\"_blank\" rel=\"noopener noreferrer\">EFTA<\/a> regulations (MDD adopted by EFTA).\u00a0<\/em><\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>\u00a0<\/em>\u201cNOTE 1\u00a0\u00a0\u00a0 \u00a0This standard is intended to be applied in its entirety only. Selected clauses or subclauses may be not applicable due to the specific type of equipment under consideration. It is necessary to understand and apply Clauses 1 to 5. It is also recommended to understand and apply those clauses which contain general requirements related to a specific subclause. Elements of the standard that are not cited in Table ZZ.1 may be relevant for the appropriate fulfilment of certain essential requirements through indirect reference, and for safety and performance aspects of the device, that are not addressed through essential requirements.\u201d<\/span><\/p>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>You must use the whole standard.\u00a0 You can\u2019t just pick and choose clauses you need the whole enchilada otherwise not a valid evaluation of the product.\u00a0 But you may be able to cite &amp; provide justification that certain clauses &amp; sub-clauses don\u2019t apply to your specific device. \u00a0Clauses 1 thru 5 of the standard must be applied and understood completely and well. \u00a0These clauses include the scope of the standard, the object, how the Particular and Collateral standards of the 60601 series of standards apply, which standards are normative references and how they work (dated vs undated), terminology &amp; definitions, general requirements which includes discussion of &amp; requirements for:<\/em><\/span><\/p>\n<ul>\n<ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Conditions of the equipment to be tested and analyzed <\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>The Risk Management Process<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Essential Performance<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Expected Service Life<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Equivalent Safety <\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Parts that touch the Patient but aren\u2019t to be marked as Applied Parts<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Single Fault Condition<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Component requirements<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Use of High-Integrity Components<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Power Supply issues<\/em><\/span><\/li>\n<\/ul>\n<\/ul>\n<\/ul>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>And General Requirements for Testing the ME Equipment<\/em><\/span><\/p>\n<ul>\n<ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Type Tests<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Number of Samples for testing<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Environmental issues<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Test conditions<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Repairs and modifications<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Humidity preconditioning<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Sequence of tests<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Determination of Applied Parts vs Accessible Parts<\/em><\/span><\/li>\n<\/ul>\n<\/ul>\n<\/ul>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>\u00a0Also, all clauses that apply general requirements related to specific sub-clauses must be considered &amp; addressed.\u00a0 Even if there are specific sub-clauses that aren\u2019t cited in the Table ZZ.1 that doesn\u2019t mean they aren\u2019t valid to help meet some of the ER\u2019s even if indirectly &amp; for safety &amp; performance aspects of the device, not addressed through the ER\u2019s.<\/em><\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">\u201cNOTE 2 \u00a0\u00a0\u00a0\u00a0Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance to the <a href=\"http:\/\/bit.ly\/MDDConsolidated_93_42_EECand2007_47_EC\" target=\"_blank\" rel=\"noopener noreferrer\">MDD (Directive 93\/42\/EEC amended by 2007\/47\/EC)<\/a>. This means that risks have to be reduced &#8220;as far as possible&#8221;, &#8220;to a minimum&#8221;, &#8220;to the lowest possible level&#8221;, &#8220;minimized&#8221; or &#8220;removed&#8221;, according to the wording of the corresponding essential requirement.\u201d<\/span><\/p>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Where there is a reference made from a clause of the standard <a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">EN 60601-1:06 + A1:13<\/a> to the risk management process, the risk management process needs to be in compliance with the MDD.\u00a0 This means that risks have to be reduced according to the specific wording of the corresponding ER.\u00a0 Such as with the wording \u201cas far as possible\u201d, \u201cto a minimum\u201d, etc.<\/em><\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">\u201cNOTE 3\u00a0\u00a0\u00a0\u00a0 With respect to note 4 of clause 4.2.2 General requirement for risk management, the manufacturer\u2019s policy for determining <strong>acceptable risk <\/strong>must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the directive.\u201d<\/span><\/p>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Note 4 of clause 4.2.2 \u201cGeneral requirement for risk management\u201d states: <\/em><\/span><\/p>\n<p style=\"padding-left: 90px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>\u201cNOTE 4\u00a0\u00a0\u00a0\u00a0 Where requirements of this standard refer to freedom from unacceptable RISK, acceptability or unacceptability of this RISK is determined by the MANUFACTURER in accordance with the MANUFACTURER\u2019S policy for determining acceptable RISK.\u201d\u00a0 <\/em><\/span><\/p>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>This infers that the standard <a href=\"http:\/\/bit.ly\/ed3dot1IEC60601-1\" target=\"_blank\" rel=\"noopener noreferrer\">IEC 60601-1:05 + A1:12<\/a> requires that Risk is determined by the Manufacturer\u2019s policy for determining acceptable risk which is the Risk Management Process under <a href=\"http:\/\/bit.ly\/ISO14971_2007\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 14971:2007<\/a> per the IEC standard (ed. 3.1) but once you get into the MDD &amp; EN Harmonized standard it will be <a href=\"http:\/\/bit.ly\/DS_EN_ISO14971_2012\" target=\"_blank\" rel=\"noopener noreferrer\">EN ISO 14971:2012<\/a> based on the conversion done in Annex ZA.<\/em><\/span><\/p>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>So, continuing on &#8212; Risk is determined by the Manufacturer\u2019s policy for determining acceptable risk which is the Risk Management Process under <a href=\"http:\/\/bit.ly\/DS_EN_ISO14971_2012\" target=\"_blank\" rel=\"noopener noreferrer\">EN ISO 14971:2012<\/a> for the ER\u2019s 1, 2, 5, 6, 7, 8, 9, 11 &amp; 12 of the MDD.\u00a0 When you look at Table ZZ.1 you will see in a greyed out area of the top of each ER section for ER\u2019s 1, 2, 5, 6, 7, 8, 9, 11 &amp; 12 there is a note that says \u201cGeneral Guidance note 2 and 3 shall be observed\u201d which infers that you need to follow the risk management process stated in these specific ER\u2019s per <a href=\"http:\/\/bit.ly\/DS_EN_ISO14971_2012\" target=\"_blank\" rel=\"noopener noreferrer\">EN ISO 14971:2012<\/a> Annex ZA (for the MDD) which is where all the modifications of the Risk Management standard were made by the EU Commission causing total havoc for the EN ISO version of the standard even though not in the main text of the standard Annex ZA has caused a total mess of what was once a specific standard and now has been jumbled and makes it hard to meet risk management requirements for multiple countries when one of them is the EU and there are other countries involved as <a href=\"http:\/\/bit.ly\/ISO14971_2007\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 14971<\/a> &amp; <a href=\"http:\/\/bit.ly\/DS_EN_ISO14971_2012\" target=\"_blank\" rel=\"noopener noreferrer\">EN ISO 14971<\/a> are in direct conflict with each other.\u00a0 You can meet one but not both at the same time from what I have surmised.<\/em><\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">\u201cNOTE 4 \u00a0\u00a0\u00a0\u00a0References in the clauses 3 to 17 or in the Annexes of this standard specify whether the normative references listed in Clause 2 as cited in Annex ZA are to be applied in whole or in part.\u201d<\/span><\/p>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Clauses 3 to 17 (the meat of the standard) and the Annexes of the standard <a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">EN 60601-1:06 + A1:13<\/a> specify whether the mandatory (normative) references listed in Clause 2 (the clause for all the Normative References of the standard), which in the EN version of the standard is replaced by the citations in Annex ZA for clause 2, are to be applied in whole (the whole standard) or in part (a certain portion of the standard) as noted in the standard itself. \u00a0<\/em><\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">\u201cNOTE 5 \u00a0\u00a0\u00a0\u00a0This Annex ZZ is based on Normative References according to Annex ZA, replacing the references in the core text.\u201d<\/span><\/p>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Annex ZZ of this <a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">EN 60601-1:06 + A1:13<\/a> standard is based on the Normative references of Annex ZA (Normative Standards that were replaced from IEC &amp; ISO standards to the European EN, EN ISO, &amp; HD standards in the <a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">EN 60601-1:06 + A1:13<\/a> version of the standard).\u00a0 Bottom line this means that all the IEC 60601-1:05 + A1:12 normative references are to be replaced by the Annex ZA normative standards references for the <a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">EN 60601-1:06 + A1:13<\/a> version of the standard.<\/em><\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">\u201cWARNING: Other requirements and other EU Directives and Regulations may be applicable to the product(s) falling within the scope of this standard.\u201d<\/span><\/p>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>This simply means that the MDD is not the only Directive that may apply.\u00a0 Some examples of Directives and Regulations that may apply include the following examples:<\/em><\/span><\/p>\n<ul>\n<ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Restriction of Hazardous Substances (RoHS2) Directive\u00a0<\/em><\/span><\/li>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>This is coming up for most medical device manufacturers in June of 2014.\u00a0 That\u2019s not a lot of time to get ready for this process.\u00a0 If you would like to learn more about this process for the medical device manufacturer please join me in a presentation on RoHS2 for the Medical Device Industry on 17 Dec 2013.<\/em><\/span><\/li>\n<\/ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Waste of Electrical and Electronic Equipment (WEEE) Directive<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Machinery Directive<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Radio and Telecommunications Terminal Equipment (R&amp;TTE) Directive<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Privacy \/ data protection Clinical data and other personal data Directive<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Regulation on electronic instructions for use of medical devices<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Etc.<\/em><\/span><\/li>\n<\/ul>\n<\/ul>\n<\/ul>\n<p style=\"padding-left: 60px;\"><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><em>Note, that Axon Lawyers has prepared <a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2013\/11\/Axon_Regulation_Chart_Med_Dev_130423.docx\" target=\"_blank\" rel=\"noopener noreferrer\">a document for their local RAPS group on the associated Directives that may apply to your EU medical devices<\/a> and they have been generous to allow all of us to have access to it.\u00a0 So, thank you Erik Vollebregt for one of your many resources that has helped my clients and I to understand better the implication of the Warning in Annex ZZ of <a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">EN 60601-1:06 + A1:13<\/a>.<\/em><em>\u00a0<\/em><\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">So, get a copy of the standard <a href=\"http:\/\/bit.ly\/DS_EN60601-1_06_A1_13\" target=\"_blank\" rel=\"noopener noreferrer\">EN 60601-1:06 + A1:13<\/a> so you can have access to the important Annex ZA and Annex ZZ.\u00a0 \u00a0If you follow the details noted there you should be in good shape. Annex ZZ is a useful tool to make it easier to know what ERs are applicable to the 60601-1 standard and what is expected instead of doing it blindly for so many years without that support. Last week I actually used this table in Annex ZZ very successfully to audit a MDD Technical Files ER checklist and it provided a wealth of information that just made my life a lot easier and will make yours a lot easier too if you need to put an ER Checklist together for your next Technical File or for a Design Dossier too.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">I remember when first working on the IEC based standard that I am a convener of (IEC\/ISO 80601-2-58) I was requested to work on the parallel EN standard. \u00a0Someone in our Joint Working Group (JWG) suggested that we (the JWG) put together an Annex ZZ but I was later told by some in Europe the 60601 series of standards wasn&#8217;t doing that yet because of some political issues that I was never clear on. So, I guess we finally broke that cycle, many years later, and now many of the 60601 series of standards are slated to go thru this process (41 thru the end of 1<sup>st<\/sup> quarter of 2014). I think at first probably the more popular ones will get processed and who knows how long it will take to get all of them processed thru.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">If your company needs help with edition 3.0 or 3.1 for EN or IEC 60601-1 gap analysis, preparation of the risk management file for these versions of the standard, or training on the Standard, please contact Leo Eisner at:\u00a0<a href=\"mailto:Leo@EisnerSafety.com\"><strong>Leo@EisnerSafety.com<\/strong><\/a>.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Sign-up for our monthly newsletter to keep up to date on all our posts. \u00a0Go to the upper left hand corner of any page on the site and sign-up to enjoy articles like this. \u00a0Make sure to reply to the confirmation e-mail otherwise you won&#8217;t be signed up.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization &amp; Impact of Annex ZA &amp; ZZ are discussed in this blog.<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[61,15,16,403,404,1131,1132,1133,36,92,1134,525,1135,1136,1137,1138,63,64,1139,1140,27,185,884,138,1127,206,13,218,53,94,4,255,12,28,891,892,22,330,266,174,175,149,992,665,5,142,1128],"class_list":["post-3531","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-a1","tag-amendment-1","tag-annex-za","tag-annex-za-zz","tag-annex-zz","tag-cenelec","tag-collateral-standard","tag-efta","tag-en-14971","tag-en-60601-106-a113","tag-en-60601-106-amendment-113","tag-en-iso-14971","tag-en-iso-149712012","tag-en60601","tag-en60601-1","tag-en60601-106-a113","tag-en60601-106-amendment-113","tag-escnews","tag-eu","tag-eu-harmonized-standards","tag-eu-rohs","tag-eu-rohs2","tag-european-commission","tag-iec","tag-iec-60601-1","tag-iec60601-1","tag-iec60601-1-3rd-ed","tag-iso-14971","tag-list-of-harmonized-standards","tag-mdd","tag-mdd-amendment","tag-mdd-harmonized-standards","tag-mdd-harmonized-standards-list","tag-medical","tag-medical-device","tag-medical-device-directive","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-oj","tag-ojeu","tag-risk-management","tag-rohs","tag-rohs2"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3531","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=3531"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3531\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3531"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3531"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3531"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}