New List of Standards for the General Product Safety Directive 2001/95/EC

Earlier today, the European Commission published in its Official Journal a new list of European harmonized standards that pertains to the General Product Safety Directive 2001/95/EC. This list of standards may be used by manufacturers of related products to prove their products comply with the safety requirements of this directive.

The following standards have been added to the list:

EN 15649-2:2009+A1:2012
Floating leisure articles for use on and in the water — Part 2: Consumer information

EN 15649-3:2009+A1:2012
Floating leisure articles for use on and in the water — Part 3: Additional specific safety requirements and test methods for class A devices

EN 15649-4:2010+A1:2012
Floating leisure articles for use on and in the water — Part 4: Additional specific safety requirements and test methods for class B devices

EN 15649-5:2009
Floating leisure articles for use on and in the water — Part 5: Additional specific safety requirements and test methods for class C devices

EN 15649-6:2009
Floating leisure articles for use on and in the water — Part 6: Additional specific safety requirements and test methods for class D devices

EN 15649-7:2009
Floating leisure articles for use on and in the water — Part 7: Additional specific safety requirements and test methods for class E devices

EN 60065:2002
Audio, video and similar electronic apparatus — Safety requirements
IEC 60065:2001 (Modified)

EN 60950-1:2006
Information technology equipment — Safety — Part 1: General requirements
IEC 60950-1:2005 (Modified)

As you know, the General Product Directive (2001/95/EC) does not require the affixing of the CE marking. Nevertheless, it allow manufacturers to leverage the standards to obtain a presumption of conformity with the requirements of the directive.

The new list of harmonized standards will be added to our Library shortly.

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2 thoughts on “New List of Standards for the General Product Safety Directive 2001/95/EC”

  1. We did a assessment of our product and found that it is not covered under the medical device directive. The product is a accessory used in radiation imaging. There are no electrical components. We would like to affix the “CE” mark but do not see a product group for our product. We make medical devices that fall under the medical device directive which allows us to affix the “CE” mark. Based on the product assessment, would it be safe to say it does not require a “CE” mark?

    • Hi Mark, Thank you for your question. I would say that it can only be safe to say that the CE marking needs or does not need to be affixed if all directives have been taken into account. Is the product covered by the definition of medical device or accessory to a medical device as defined by Directive 93/42/EC? Does the intended purpose correspond with the criteria in the Directive? If the Medical Device Directive does not apply, are there maybe other CE directives that do apply? If the answers to these questions are “no”, and none of the CE directives apply, in that case you may NOT affix the CE marking.

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