Treggers,
Below are some guidelines for Certification to the TTE Directive. These
guidelines are as we percieve them. How far off are they, if they are? And
where specifically are they off? I welcome and encourage different
information. Please respond if the information here is new to you or different
from the information you've been given. I'll have our research department
discuss each issue as it arises and post the response to T-REG.
This is a relatively high-level approach, and has left the details (standards,
testing, design, etc.) to individual implementation schemes.
Again, I welcome your information.
Routes to Certification for TTE Directive
ROUTE 1
This involves the following:
EC Type Examination by the Notified Body from test results prepared by an
approved test house as per Annex I of the TTE Directive
and
a Declaration of Conformity (DoC) to Type from the manufacturer with his
manufacturing quality system approved by the Notified Body to the requirements
of Annex II or III of the Directive.
How to Use the Annexes
Annex I-Type Examination
A notified body ascertains and attests a TEST SAMPLE to the TTE
Directive
and issues an EC Type examination certificate. The tests required depend on
the particular type of equipment being tested.
Annex II
A DoC from the manufacturer with the type on the examination
certificate.
A Notified Body does Product Checks at random intervals agreed between the
notified body and the manufacturer.
Annex III
DoC from the manufacturer as Annex II except a Notified Body assesses,
approves and audits an Approved Quality System for Production.
ROUTE 2
The manufacturer issues a DoC as required in Annex IV of the TTE Directive.
This means having Full Quality Assurance. A Notified Body assesses, approves
and audits the QA system. There is no Type Examination required with this
route.
2 Options
2.1 Digital Equipment Only
2.1.1 With Type Examination
In principle approval of digital equipment presents a straight forward since
CTRs exist for a range of digital equipment. Satisfactory testing to the
appropriate CTRs means the Notified Body can issue a Type Examination
Certificate for the system and therefore the manufacturer can raise a DoC and
decide whether to use the Products Checks or Production QA route.
2.1.2 Without Type Examination
Annex IV of the TTE Directive allows a manufacturer to issue DoCs for its
products providing it has Full Quality Assurance as outlined above. This
essentially means having a quality management system that fulfils the
requirements of ISO9001or similar.
2.2 Analogue and Digital Equipment
There are no CTRs for analogue equipment or for testing analogue lines into a
digital equipment. In UK analogue equipment is typically tested to NTR 3 or 8
depending on the type of port.
2.3 Hybrid Approach
BABT have informed us that a hybrid approach is acceptable for modular systems.
e.g. where a system comprises digital modules that have been assessed to the
requirements of the CTRs and then the manufacturer wishes to sell analogue
modules in a specific EU country he can use the evidence gained on the digital
modules and include this in his technical file for the application for national
approval for the analogue modules. This saves on testing as he does not have to
have the digital modules re-tested to the CTRs.
3 What Can you do?
Based on the above the following is a suggested approach:
. Identify the appropriate routes for certification,
. Identify the CTRs to be used or the national standards,
. Make arrangements with approved EU test labs to have the testing performed,
. Act to have your quality system assessed by BABT for approval under Annex II,
III, or IV,
. Appoint an authorised representative then submit the application for the EC
Type Examination to BABT or for national approval as required,
Wait.
Rick Towner
Technology International
