Archive for May, 2012
The European Commission has been busy updating lists of European harmonized standards for various product directives. Here are the updates to the Official Journal (OJ) of the European Union, looking back from the most recent:
May 4, 2012 – Updates to the ATEX Directive (94/9/EC), the European CE directive that applies to equipment used in potentially explosive atmospheres.
The list introduces two new European harmonized standards:
- EN 13617-2:2012 Petrol filling stations – Part 2: Safety requirements for construction and performance of safe breaks for use on metering pumps and dispensers. Replaces the 2004 version with the same number and must be applied by September 30, 2012.
- EN 60079-11:2012 Explosive atmospheres – Part 11: Equipment protection by intrinsic safety ‘i’ (IEC 60079-11:2011). Replaces EN 60079-11:2007 + EN 60079-27:2008 + EN 61241-11:2006 and must be applied by August 4, 2014.
For explanation of the new EN 60079 standard and other updates, register for this July 17 seminar: Hazardous Location Product Safety Compliance for North America (UL & CSA), EU (ATEX) & World (IECEx)
April 11, 2012 – Updates to the Radio and Telecommunication Terminal (R&TTE) Directive (1999/5/EC) and the EMC Directive (2004/108/EC).
February 29, 2012 – Updates to the Machinery Directive (2006/42/EC).
These updated lists are important for manufacturers of relevant CE-marked products that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directives, you’ll need to reevaluate your products against the updated or new standards and update your Declaration of Conformity.
Request pricing and lead time for CE Mark testing.
Effective last month, Brazilian National Certification Bodies (NCBs) and CB Testing Laboratories (CBTLs) have been suspended from the IECEE CB Scheme. This is the first time that the IECEE has suspended a member.
The suspension is attributed to additional accreditation requirements of Brazil’s regulatory authority, the National Institute of Metrology, Quality and Technology (INMETRO). INMETRO requires that CB test reports and certificates come from a testing laboratory accredited by INMETRO or an Accreditation Body that is a signatory of the International Laboratory Accreditation Cooperation Mutual Recognition Agreement (ILAC MRA). This requirement is not in line with the requirements of the IECEE, which is based on a Peer Assessment System between members of the IECEE CB Scheme.
The suspension prevents IECEE members from accepting test certificates and test reports from Brazil.
The IECEE CB Scheme is an international cooperation between 65 NCBs with hundreds of testing laboratories located in 50 participating countries. It is based on the principal of mutual recognition of test results for obtaining national safety certification of electrical equipment and components.
According to the IECEE Executive Secretary, Pierre de Ruvo, the suspension will be cancelled and full membership reinstated as soon as an agreement is reached with INMETRO and/or the Brazilian Committee of Electricity, Electronics, Lighting and Telecommunication (COBEI).
Laboratories – Learn how to become a CBTL of a U.S.-based NCB.
Manufacturers – Get a CB Scheme test report or test certificate.
Register for a free webinar: Using the CB Scheme to Access the World Marketplace.
For Medical Electrical Equipment product safety compliance in Canada, Health Canada currently recognizes both the second edition of IEC 60601-1, published in 1988, and the third edition, published in 2005. In October, 2008, Health Canada published a notice indicating that until June 1, 2012, conformity to the second edition of IEC 60601-1 and its related collateral and particular standards would be accepted. After June 1, 2012, conformity to the third edition would be required.
New editions of particular standards (specific to a particular device type and designated as IEC 60601-2-X) harmonized with the third edition of IEC 60601-1 have, in many cases, not yet been published, or have been published only recently, making a full transition to the entire family by the June 1, 2012 deadline impossible.
To address this, on March 22, Health Canada issued Additional Guidance on Transition from the Second to the Third Editions of the IEC 60601 Family of Standards on Health Canada’s List of Recognized Standards. It states:
- If there is not a particular standard that is directly applicable to the device as of June 1, 2012, it should conform to IEC 60601-1 3rd edition and its applicable collateral standards (that is, IEC 60601-1-X).
- If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1 3rd edition and its applicable collateral standards in addition to this particular standard.
- If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply. During this transition, Health Canada will accept conformity to both editions and related collateral standards.
These transition rules will not be applied retroactively. If the manufacturer currently holds a license for a device that was tested according to IEC 60601-1 2nd edition, you do not need to submit additional data, unless there is a significant change to the product as defined in the Guidance for the Interpretation of Significant Change of a Medical Device.
Keep in mind that provincial or territorial electrical safety requirements are separate and distinct from the requirements of the Health Canada regulations. For further information regarding these requirements, contact the applicable regulatory authorities. A listing of some of these authorities is available here.
The Health Canada website should be consulted for the most current List of Recognized Standards.
For the 3rd edition implementation schedule for the United States, see this Compliance Today post.
Later this month, MET is hosting a free Medical Equipment Regulatory Compliance Seminar in Texas. It features presentations on 60601-1 for product safety and EMC compliance, as well as CE marking.