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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

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