rfu-rst-028 application of modules a1 and h1 according to ... - CIRCA
rfu-rst-028 application of modules a1 and h1 according to ... - CIRCA
rfu-rst-028 application of modules a1 and h1 according to ... - CIRCA
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RECOMMENDATION FOR USE<br />
CO-ORDINATION BETWEEN NOTIFIED BODIES<br />
DIRECTIVE 2008/57/EC AND SUBSEQUENT AMENDMENTS<br />
ON THE INTEROPERABILITY OF THE RAILWAY SYSTEMS<br />
WITHIN THE UNION<br />
TITLE<br />
APPLICATION OF MODULES A1 AND H1 ACCORDING TO TSI FREIGHT WAGON<br />
ORIGINATOR SUBJECT RELATED TO<br />
EISENBAHNCERT, CETREN,<br />
LUXCONTROL, VUZ<br />
REVISIONS<br />
TSI FREIGHT WAGON<br />
Issue 01<br />
-original RFU<br />
Issue 02<br />
-New Sections: B.6, C<br />
-general update on references (e.g. adding <strong>of</strong> 2009/107/EC)<br />
DESCRIPTION AND BACKGROUND EXPLANATION<br />
RECOMMENDATION FOR USE<br />
RFU-RST-<strong>028</strong><br />
Issue 04<br />
Date 08/02/2012<br />
Page 1 <strong>of</strong> 5<br />
Certification <strong>of</strong> Interoperability Constituents <strong>according</strong> <strong>to</strong> TSI Freight Wagon<br />
(2006/861/EC, 2009/107/EC) – “Existing solutions” for Interoperability Constituents<br />
Current state:<br />
A certification <strong>of</strong> Interoperability Constituents <strong>according</strong> <strong>to</strong> TSI Freight Wagon<br />
(2006/861/EC, 2009/107/EC) is conducted by choosing module A, A1 or H1, provided that<br />
an “existing solution” is concerned (6.1.2.2, page L344/76).<br />
Extract <strong>of</strong> TSI Freight Wagon (6.1.2.2):<br />
If an existing solution for an interoperability constituent is already on the European market<br />
before this TSI enters in<strong>to</strong> force, then the following process applies.<br />
The manufacturer shall demonstrate that tests <strong>and</strong> verification <strong>of</strong> IC’s have been<br />
considered successful for previous <strong>application</strong>s under comparable conditions. In this case<br />
these assessments shall remain valid in the new <strong>application</strong>. In this case, the type can be<br />
considered as already approved <strong>and</strong> an assessment <strong>of</strong> the type is not necessary.<br />
In case <strong>of</strong> the manufacturer for example opts for procedure “full quality management<br />
system (module H1)” then the conditions set out in TSI Freight Wagon Annex Q (pages<br />
L344/321 <strong>to</strong> 324) apply.<br />
Extract <strong>of</strong> TSI Freight Wagon (Module H1):<br />
1. This module describes the procedure whereby the manufacturer or his authorised<br />
representative established within the Community who satisfies the obligations <strong>of</strong> point 2,<br />
ensures <strong>and</strong> declares that the interoperability constituent concerned satisfies the<br />
requirements <strong>of</strong> the TSI that apply <strong>to</strong> it.<br />
3.2 The quality management system must ensure compliance <strong>of</strong> the interoperability
RECOMMENDATION FOR USE<br />
CO-ORDINATION BETWEEN NOTIFIED BODIES<br />
DIRECTIVE 2008/57/EC AND SUBSEQUENT AMENDMENTS<br />
ON THE INTEROPERABILITY OF THE RAILWAY SYSTEMS<br />
WITHIN THE UNION<br />
constituent with the requirements <strong>of</strong> the TSI that apply <strong>to</strong> it.<br />
RECOMMENDATION FOR USE<br />
RFU-RST-<strong>028</strong><br />
Issue 04<br />
Date 08/02/2012<br />
Page 2 <strong>of</strong> 5<br />
Questions:<br />
The description for “existing solutions” for interoperability constituents in TSI Freight<br />
Wagon (6.1.2.2, page L344/76) in context with provisions stated in module H1 prompts<br />
the following questions:<br />
The fundamental question is - what TSI requirements apply <strong>to</strong> an “existing solution” <strong>of</strong><br />
interoperability constituent?<br />
1) When does the existing solution comply with current TSI requirements?<br />
2) When does the existing solution not comply with current TSI requirements but<br />
prior <strong>to</strong> entering in<strong>to</strong> force <strong>of</strong> TSI Freight Wagon (01/2007) was homologated<br />
on basis <strong>of</strong> fulfilment <strong>of</strong> requirements <strong>of</strong> norms <strong>and</strong> st<strong>and</strong>ards (i.e. DIN, EN,<br />
UIC-leaflets) at that time?<br />
3) When was the “existing solutions” <strong>of</strong> interoperability constituent defined as TSIcompliant<br />
(i.e. bogie, annex Y, page L344/405 <strong>to</strong> 407, wheelsets)?<br />
RFU PROPOSAL<br />
Until such time as a definitive interpretation <strong>of</strong> the TSI becomes available, NB-Rail<br />
suggests the following interpretation <strong>of</strong> the TSI.<br />
When applying module H1 or A1“existing solution” <strong>of</strong> interoperability constituent the<br />
apportionment <strong>of</strong> tasks are as follows:<br />
A) Tasks <strong>of</strong> NoBo’s when applying module H1 or A1 “existing solution”<br />
The issue <strong>of</strong> a certificate <strong>according</strong> module H1 or A1 “existing solution” is possible under<br />
the following conditions:<br />
A.1) NoBos check whether appropriate evidence <strong>of</strong> the tasks apportioned <strong>to</strong> the<br />
client exists <strong>and</strong> that it is demonstrated that the constituent was successful<br />
under comparable conditions as under point 2) above. If the existing solution is<br />
compliant with norms <strong>and</strong> st<strong>and</strong>ards which were valid at the time when TSI<br />
entered in<strong>to</strong> force, then the Notified Body can consider the existing solution <strong>to</strong><br />
be type-approved. The <strong>application</strong> <strong>of</strong> norms <strong>and</strong> st<strong>and</strong>ards older than the<br />
above-mentioned has <strong>to</strong> be justified by the client (manufacturer) by<br />
comparison with the ones which were valid at the time when TSI entered in<strong>to</strong><br />
force.
RECOMMENDATION FOR USE<br />
CO-ORDINATION BETWEEN NOTIFIED BODIES<br />
DIRECTIVE 2008/57/EC AND SUBSEQUENT AMENDMENTS<br />
ON THE INTEROPERABILITY OF THE RAILWAY SYSTEMS<br />
WITHIN THE UNION<br />
RECOMMENDATION FOR USE<br />
RFU-RST-<strong>028</strong><br />
Issue 04<br />
Date 08/02/2012<br />
Page 3 <strong>of</strong> 5<br />
A.2) NoBos evaluate the quality management system <strong>to</strong> make sure the<br />
manufacturing process meets the pertaining requirements. In particular, the<br />
assessment should take in<strong>to</strong> account whether the manufacturer built the<br />
existing solution himself (H1 only).<br />
A.3) NoBos verify the products by examination <strong>and</strong> testing <strong>of</strong> every constituent or<br />
by statistical verification (A1).<br />
B)Conditions <strong>to</strong> be met by the applicant (manufacturer) when applying module H1 or A1<br />
<strong>to</strong> “existing solutions”<br />
B.1) He establishes evidence that the interoperability constituent was on the<br />
European market before this TSI Freight Wagon entered in<strong>to</strong> force. This<br />
means that the constituent has been accepted for unlimited operation in any<br />
member state.<br />
B.2) He provides evidence that tests <strong>and</strong> verification <strong>of</strong> IC’s have been considered<br />
successful for previous <strong>application</strong>s under comparable conditions in order <strong>to</strong><br />
establish the approved type <strong>and</strong> the st<strong>and</strong>ards which apply <strong>to</strong> it. The st<strong>and</strong>ards<br />
which apply will be those used when the existing solution was originally<br />
approved <strong>and</strong> authorised for use. The conditions for the newly manufactured<br />
constituent should be comparable in respect <strong>of</strong> both technical (such as similar<br />
axle load or speed) <strong>and</strong> operational conditions. The client should identify<br />
whether the existing solution is compliant with norms <strong>and</strong> st<strong>and</strong>ards which<br />
were valid at the time when TSI entered in<strong>to</strong> force, then the Notified Body can<br />
consider the existing solution <strong>to</strong> be type-approved. If the existing solution is<br />
compliant with norms <strong>and</strong> st<strong>and</strong>ards older than the above-mentioned, the client<br />
should justify the <strong>application</strong> by comparison with those which were valid at the<br />
time when TSI entered in<strong>to</strong> force.<br />
B.3) Where the “existing solution” <strong>of</strong> an interoperability constituent is defined in the<br />
TSI (for example in Annex Y or FF) there is no need for evidence <strong>according</strong> <strong>to</strong><br />
point 1) <strong>and</strong> 2).<br />
B.4) He sets up <strong>and</strong> integrates within his quality management system a procedure<br />
<strong>to</strong> establish <strong>and</strong> demonstrate TSI conformity <strong>according</strong> <strong>to</strong> the approved type<br />
established in point 2) (H1).<br />
B.5) He submits his products <strong>to</strong> the NoBo for individual or statistical verification<br />
(A1).<br />
B.6) When compiling the necessary evidence <strong>according</strong> <strong>to</strong> TSI WAG 2006/861/EC<br />
Annex Q Module H1 (3.2) – especially those evidence defined by 3 rd <strong>and</strong> 6 th<br />
indent - the applicant (manufacturer) shall consider the listing contained in<br />
TSI WAG 2006/861/EC Annex Q Module A1 (3) until this aspect becomes<br />
more clearly defined in a TSI.
RECOMMENDATION FOR USE<br />
CO-ORDINATION BETWEEN NOTIFIED BODIES<br />
DIRECTIVE 2008/57/EC AND SUBSEQUENT AMENDMENTS<br />
ON THE INTEROPERABILITY OF THE RAILWAY SYSTEMS<br />
WITHIN THE UNION<br />
RECOMMENDATION FOR USE<br />
RFU-RST-<strong>028</strong><br />
Issue 04<br />
Date 08/02/2012<br />
Page 4 <strong>of</strong> 5<br />
C)Specific aspects <strong>to</strong> be considered at the assessment <strong>of</strong> the ICs Wheelset, Wheel <strong>and</strong><br />
Axle when applying module H1 or A1 <strong>to</strong> “existing solutions”<br />
C.1) The assessment <strong>of</strong> the ICs Wheelset, Wheel <strong>and</strong> Axle against TSI WAG<br />
2006/861/EC in connection with 2009/107/EC <strong>and</strong> the related ERA List <strong>of</strong><br />
applicable st<strong>and</strong>ards requires <strong>to</strong> take in<strong>to</strong> account the st<strong>and</strong>ards EN13260,<br />
EN13261 <strong>and</strong> EN13262.<br />
C.2) Theses st<strong>and</strong>ards were already in force when TSI WAG 2006/861/EC<br />
entered in<strong>to</strong> force. Ins<strong>of</strong>ar the assessment process <strong>of</strong> an existing solution is<br />
subject <strong>to</strong> the requirements <strong>of</strong> A.1 above.<br />
C.3) That means that the requirements for Design Testing as well as for<br />
Production Quality Testing as contained in these st<strong>and</strong>ards must be<br />
respected.<br />
C.4) Therefore for <strong>application</strong> <strong>of</strong> <strong>modules</strong> A1 or H1 the applicant has <strong>to</strong> be in<br />
possession <strong>of</strong> the necessary evidence resulting from testing <strong>and</strong> verification<br />
<strong>of</strong> the IC in accordance <strong>to</strong> B.2 above.<br />
C.5) Additionally when applying module H1 the NoBo must assess the suitability<br />
<strong>of</strong> the presented evidence relating <strong>to</strong> the aspects <strong>of</strong> Production Quality<br />
Testing.<br />
C.6) According <strong>to</strong> EN13260(E.1), EN13261(I.1) <strong>and</strong> EN13262(E.1) which cover<br />
the aspects <strong>of</strong> Production Quality, any Production Quality Testing result can<br />
only be related <strong>to</strong> that particular Production Process which has been applied<br />
at the production <strong>of</strong> the test specimen for such a test. This is obviously a<br />
direct consequence <strong>of</strong> the need <strong>to</strong> apply a suitable <strong>and</strong> reproducible<br />
Production Process at these product categories.<br />
C.7) As long as no other requirements are given by a TSI, this Production Process<br />
shall be deemed <strong>to</strong> include Manufacturing <strong>of</strong> Raw Materials, Intermediate<br />
Manufacturing Stages <strong>and</strong> Final Manufacturing Stage for Wheels <strong>and</strong> Axles<br />
<strong>and</strong> Intermediate Manufacturing Stages <strong>and</strong> Final Manufacturing Stage for<br />
Wheelsets.<br />
C.8) A change <strong>of</strong> suppliers involved in the Production Process, a change <strong>of</strong> the<br />
Production Process itself <strong>and</strong> an appreciable change <strong>of</strong> the Product<br />
Geometry shall be deemed as a change <strong>of</strong> design <strong>according</strong> <strong>to</strong> the st<strong>and</strong>ards<br />
EN13260, EN13261 <strong>and</strong> EN13262. In such a case the Production Quality<br />
Tests (provisional <strong>and</strong> definitive) as defined in these st<strong>and</strong>ards – in particular<br />
the fatigue tests – must be performed also for those products which are<br />
derived from the changed Production Process.<br />
C.9) The applicant must notify any change <strong>to</strong> the Notified Body <strong>and</strong> must<br />
demonstrate <strong>to</strong> the satisfaction <strong>of</strong> the Notified Body for any change whether it<br />
is appreciable or not.
RECOMMENDATION FOR USE<br />
CO-ORDINATION BETWEEN NOTIFIED BODIES<br />
DIRECTIVE 2008/57/EC AND SUBSEQUENT AMENDMENTS<br />
ON THE INTEROPERABILITY OF THE RAILWAY SYSTEMS<br />
WITHIN THE UNION<br />
DATE OF AGREEMENT AT NB RAIL PLENARY MEETING<br />
08/02/2012<br />
RECOMMENDATION FOR USE<br />
RFU-RST-<strong>028</strong><br />
Issue 04<br />
Date 08/02/2012<br />
Page 5 <strong>of</strong> 5