Re: [PSES] EN 55032 - and other EN standards
Hi Gert, Thank you for your reply. You may be correct about other Directives, I'm not sure about that. I was speaking specifically for the Radio Equipment Directive (RED), sorry about that. For the RED, the manufacturer must create a risk assessment in all cases, regardless of what route they take. Even if harmonised standards listed on the OJ are fully applied. The RED states that the Notified Body must review the technical documentation, which includes the risk assessment. It does not make it very clear that the manufacturer's documentation must include a risk assessment even in cases when they use Module A (harmonised standards). For this reason, TCAM put out a clarifying document to confirm it. TCAM documents are not so easy to find, therefore it is also clarified in the RED guide, to eliminate confusion. Thanks, Michael. From: Gert Gremmen [mailto:g.grem...@cetest.nl] Sent: 27 November 2018 12:33 To: Michael Derby ; EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] EN 55032 - and other EN standards Thank you Michael, You correctly emphasize the importance of a risk analysis in front of testing and standard selection. And as well as important the fact that one needs to declare compliance directive, and not to the standard. But the directives almost always allow a manufacturer to obtain presumption of compliance if route A (Harmonised Standards / Manufacturers Declaration) is used. The risk analysis is mandatory for the Notified Body route. I must admit that the different directives are a bit vague on that, and i am not sure why. I would prefer the risk analysis to be part of every approval route, where the hazards covered by a HS are not to be further analysed. Gert On 27-11-2018 12:06, Michael Derby wrote: That's a good summary from Gert. I think one important thing to remember is that the EU (LVD + EMCD, or RED) approach to compliance is the manufacturer assessing their device in any way possible, to show compliance with a Directive. It's not a certification to a standard. So, if a product has a risk of causing interference in some way, or causing a safety issue, or being affected by EMC, it should be assessed - regardless if the standard exists yet, or if the standard is harmonised yet, or if the harmonised standard is listed on the Official Journal (OJ) yet. In an ideal situation, all devices would have an applicable harmonised standard which is listed on the OJ for the applicable Directive. If industry then notes that things are changing, the standard gets updated (or a new standard written) and added to the OJ with a reasonable transition period from the old standard. (Or, if the issue is critical, there may be no transition period, or standards can be withdrawn from the OJ). That's how it should work. However, we're not in this ideal situation right now, because the standards have not made it onto the OJ for (mostly) legal and administrative reasons. (Also some technical reasons, such as performance criteria, etc.) But this is not a show-stopper. The manufacturer must ascertain which tests or assessments must be carried out on their device, to show that it will not interfere, will not be interfered with, will be safe, etc. Then, do those tests (or assessments) and create their DoC. For example, if a new standard becomes published and there are test cases in there which apply to a product, a manufacturer would not say "I don't have to do that yet, because that standard is not on the OJ". The EU approach is declaration to a Directive, not certification to a standard. If a manufacturer knows that their device presents a safety or interference risk which is not covered in any of the standards, published or draft, it does not mean they should ignore it. It means they make their own way to assess it. This is where the manufacturer's risk assessment becomes so important. It is the starting point for any manufacturer; as a way for the manufacturer to determine which tests they should be doing on their device, and figuring out which standards they should look for. Of course, this is no problem for selling into the EU (it's easy to pick a standard which is not on the OJ and test to it - and that's ok in the EU); but I do appreciate that it could be problematic for other non-EU regions who look for compliance to standards on the OJ, and do not understand the subtlety that in the EU that is not mandatory. Michael. From: Gert Gremmen [mailto:g.grem...@cetest.nl] Sent: 27 November 2018 09:28 To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> Subject: Re: [PSES] EN 55032 Hi All, The document below has been published very recently and shows how and why... https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2018:764:FIN In simple language, the EC court has decided that HS are to be treated as EU-law (Elliot case). This has a lot
Re: [PSES] EN 55032 - and other EN standards
Thank you Michael, You correctly emphasize the importance of a risk analysis in front of testing and standard selection. And as well as important the fact that one needs to declare compliance directive, and not to the standard. But the directives almost always allow a manufacturer to obtain presumption of compliance if route A (Harmonised Standards / Manufacturers Declaration) is used. The risk analysis is mandatory for the Notified Body route. I must admit that the different directives are a bit vague on that, and i am not sure why. I would prefer the risk analysis to be part of every approval route, where the hazards covered by a HS are not to be further analysed. Gert On 27-11-2018 12:06, Michael Derby wrote: That’s a good summary from Gert. I think one important thing to remember is that the EU (LVD + EMCD, or RED) approach to compliance is the manufacturer assessing their device in any way possible, to show compliance with a Directive. It’s not a certification to a standard. So, if a product has a risk of causing interference in some way, or causing a safety issue, or being affected by EMC, it should be assessed – regardless if the standard exists yet, or if the standard is harmonised yet, or if the harmonised standard is listed on the Official Journal (OJ) yet. In an ideal situation, all devices would have an applicable harmonised standard which is listed on the OJ for the applicable Directive. If industry then notes that things are changing, the standard gets updated (or a new standard written) and added to the OJ with a reasonable transition period from the old standard. (Or, if the issue is critical, there may be no transition period, or standards can be withdrawn from the OJ). That’s how it should work. However, we’re not in this ideal situation right now, because the standards have not made it onto the OJ for (mostly) legal and administrative reasons. (Also some technical reasons, such as performance criteria, etc.) But this is not a show-stopper. The manufacturer must ascertain which tests or assessments must be carried out on their device, to show that it will not interfere, will not be interfered with, will be safe, etc. Then, do those tests (or assessments) and create their DoC. For example, if a new standard becomes published and there are test cases in there which apply to a product, a manufacturer would not say “I don’t have to do that yet, because that standard is not on the OJ”. The EU approach is declaration to a Directive, not certification to a standard. If a manufacturer knows that their device presents a safety or interference risk which is not covered in any of the standards, published or draft, it does not mean they should ignore it. It means they make their own way to assess it. This is where the manufacturer’s risk assessment becomes so important. It is the starting point for any manufacturer; as a way for the manufacturer to determine which tests they should be doing on their device, and figuring out which standards they should look for. Of course, this is no problem for selling into the EU (it’s easy to pick a standard which is not on the OJ and test to it – and that’s ok in the EU); but I do appreciate that it could be problematic for other non-EU regions who look for compliance to standards on the OJ, and do not understand the subtlety that in the EU that is not mandatory. Michael. *From:*Gert Gremmen [mailto:g.grem...@cetest.nl] *Sent:* 27 November 2018 09:28 *To:* EMC-PSTC@LISTSERV.IEEE.ORG *Subject:* Re: [PSES] EN 55032 Hi All, The document below has been published very recently and shows how and why... https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2018:764:FIN In simple language, the EC court has decided that HS are to be treated as EU-law (Elliot case). This has a lot of consequences. In order to get a _privately originated text_ count as law, the EC has added a number of conditions that standards need to fulfill. These find their base in the New Legislative Framework. Some of the problems with current texts are: * Not static (by undated references to standards), so "law" changes when referenced standards update, or referenced standards are withdrawn. ( the problem is here also that ESOs are private organisations (ISO,CENELEC, CEN, ISO) can change EU law this way) * Unclear/incomplete technical specifications , link between directives essential requirements and standards technical specifications * Ambiguous test specifications, often introduced by choices a manufacturer can make on its own, so as to avoid testing. * And many more, mostly of a legal interpretation nature. The problem is not that standards are not technically suitable to show presumption of compliance, but that they are not suitable to be used as law. Secondly, the ESOs and national committees are not (yet) fully aware of the consequences
Re: [PSES] EN 55032 - and other EN standards
That's a good summary from Gert. I think one important thing to remember is that the EU (LVD + EMCD, or RED) approach to compliance is the manufacturer assessing their device in any way possible, to show compliance with a Directive. It's not a certification to a standard. So, if a product has a risk of causing interference in some way, or causing a safety issue, or being affected by EMC, it should be assessed - regardless if the standard exists yet, or if the standard is harmonised yet, or if the harmonised standard is listed on the Official Journal (OJ) yet. In an ideal situation, all devices would have an applicable harmonised standard which is listed on the OJ for the applicable Directive. If industry then notes that things are changing, the standard gets updated (or a new standard written) and added to the OJ with a reasonable transition period from the old standard. (Or, if the issue is critical, there may be no transition period, or standards can be withdrawn from the OJ). That's how it should work. However, we're not in this ideal situation right now, because the standards have not made it onto the OJ for (mostly) legal and administrative reasons. (Also some technical reasons, such as performance criteria, etc.) But this is not a show-stopper. The manufacturer must ascertain which tests or assessments must be carried out on their device, to show that it will not interfere, will not be interfered with, will be safe, etc. Then, do those tests (or assessments) and create their DoC. For example, if a new standard becomes published and there are test cases in there which apply to a product, a manufacturer would not say "I don't have to do that yet, because that standard is not on the OJ". The EU approach is declaration to a Directive, not certification to a standard. If a manufacturer knows that their device presents a safety or interference risk which is not covered in any of the standards, published or draft, it does not mean they should ignore it. It means they make their own way to assess it. This is where the manufacturer's risk assessment becomes so important. It is the starting point for any manufacturer; as a way for the manufacturer to determine which tests they should be doing on their device, and figuring out which standards they should look for. Of course, this is no problem for selling into the EU (it's easy to pick a standard which is not on the OJ and test to it - and that's ok in the EU); but I do appreciate that it could be problematic for other non-EU regions who look for compliance to standards on the OJ, and do not understand the subtlety that in the EU that is not mandatory. Michael. From: Gert Gremmen [mailto:g.grem...@cetest.nl] Sent: 27 November 2018 09:28 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] EN 55032 Hi All, The document below has been published very recently and shows how and why... https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2018:764:FIN In simple language, the EC court has decided that HS are to be treated as EU-law (Elliot case). This has a lot of consequences. In order to get a privately originated text count as law, the EC has added a number of conditions that standards need to fulfill. These find their base in the New Legislative Framework. Some of the problems with current texts are: * Not static (by undated references to standards), so "law" changes when referenced standards update, or referenced standards are withdrawn. ( the problem is here also that ESOs are private organisations (ISO,CENELEC, CEN, ISO) can change EU law this way) * Unclear/incomplete technical specifications , link between directives essential requirements and standards technical specifications * Ambiguous test specifications, often introduced by choices a manufacturer can make on its own, so as to avoid testing. * And many more, mostly of a legal interpretation nature. The problem is not that standards are not technically suitable to show presumption of compliance, but that they are not suitable to be used as law. Secondly, the ESOs and national committees are not (yet) fully aware of the consequences and are a bit reluctant.They have been used to create and approve HS on their own, where now the EC takes the lead. This creates problems especially for older standards, that have not been written with the newer standardisation requests in mind. To assess the standards for their suitability a number of HAS-experts have been nominated, and the iterative process of creating suitable harmonised standards is active for about 6 months. Gert Gremmen -- Independent Expert on CE marking Harmonised Standards (HAS-) Consultant @ European Commission for RED and EMC EMC Consultant Electrical Safety Consultant On 27-11-2018 9:43, McBurney, Ian wrote: Hello David. I would be interested in getting more information regarding these legal issues with standards and the court
