Do you interpret the European Union rules for implementing the new
EN60950-1:2006+A11:2009 (2nd Edition) safety standard on products the same way
that I do?
EN60950-1:2006+A11:2009 (2nd Edition safety standard) becomes mandatory for
Information Technology Equipment (computers, etc.) on 1 December 2010
according to the "Official Journal of the European Union" 2010/C 71/02 on page
C71/66. The only document that I have found that explains the implementation
process for standards updates is the European Commission's "Guide to the
Implementation of Directives Based on the New Approach and the Global
Approach" published in year 2000. Based on this document, I believe the
implementation rules are as follows:
1. Each individual serial number product must comply with the
2nd Edition safety standard if that individual product is
first put into service within Europe on 1 December 2010 or
later.
2. Individual serial number products complying only with
1st Edition safety (not 2nd Edition) would have to be
installed at the customer site and put into service by
30 November 2010.
3. Once the individual serial number product has been put
into service within Europe, then the product should be
maintained (repaired) in a manner that either keeps the
same safety compliance level or upgrades the product to
the latest edition of the safety standards. In other
words, additional 1st Edition compliant repair or
replacement parts may be shipped into Europe to maintain
1st Edition safety compliant products already in use
within Europe
To achieve the above, that would mean that manufacturers would have to build
2nd Edition safety compliant product well in advance of the 1 December date to
ensure that the products have time to be shipped through customs and delivered
to the customer so the customer can install the product prior to 1 December.
If a manufacturer sells services to have trained experts install the product
for the customer, that appointment to install the product would have to be set
for a date prior to 1 December for a product that only complies with the 1st
Edition safety standard.
Do you agree with my interpretation described above?
If I am correct on the European Union rules, then many manufacturers are
failing to work to implement these rules. Some are only ensuring that the
factory changes over to building 2nd Edition safety compliant products by 1
December 2010. Others are only concerned about ensuring that only 2nd Edition
compliant products are imported into Europe starting 1 December 2010.
However, I am having difficulty finding manufacturers that are attempting to
ensure that only 2nd Edition safety compliant products arrive at the ultimate
customer's site and are installed ("put into service") on 1 December or later.
SUPPORT BACKGROUND (FOR THOSE THAT HAVE NOT LOOKED AT THIS ISSUE)
The European Commission's "Guide to the Implementation of Directives Based on
the New Approach and the Global Approach" is available online at:
http://ec.europa.eu/enterprise/policies
single-market-goods/files/blue-guide/guidepublic_en.pdf
Section 2.3.1 (page 18) states the following:
"Accordingly, the new products manufactured in the Community and all
products
imported from third countries -- whether new or used -- must meet the
provisions of the applicable directives when made available for the first time
on the Community market."
"Moreover, the concept of placing on the market refers to each
individual
product, not to a type of product, and whether it was manufactured as an
individual unit or in series."
Section 2.3.2 (page 19) states the following:
* "Putting into service takes place at the moment of first use within
the
Community by the end user."
* "Products must comply with the provisions of the applicable New
Approach
directives and other Community legislation when they are put into service."
Based on the above quotes from section 2.3, the product must meet the current
directives and the current harmonized standards at the time the individual
serial number product is actually first put into service at the customer site.
It does not matter that products of the same model number and build were
already sold within the Community prior to 1 December 2010, but the focus is
on the "individual product" and when it was "put into service".
Section 2.1 (page 16) states the following:
* "Products which have been repaired (for example following a defect),
without changing the original performance, purpose or type, are not to be
considered as new products according to the New Approach directives."
* "This applies even if the product has been temporarily exported to a
third
country for repair operations."
* "Thus, maintenance operations are basically excluded from the scope
of the
directives."
Based on the above quotes from section 2.1, we can repair and maintain the
products already in use within Europe using parts that keep the same level of
safety compliance. In other words, 1st Edition compliant parts can be used to
repair 1st Edition compliant products. Of course, we could always upgrade the
safety compliance of a product by using 2nd Edition safety compliant parts (as
long as the parts are compatible in the safety reports), but this is not
required.
Thanks.
Monrad Monsen | Worldwide Compliance Officer
Oracle Compliance Engineering
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