Don't forget the European Product Liability Directive (85/374/EEC amended by 99/34/EC) and General Product Safety Directive (92/59/EEC).
Neither of these require any approvals or markings, but both require that the state of the art in safety engineering is applied, and this implies the use of all relevant standards, whether harmonised or not, and world-class expert knowledge where international standards are incomplete or inappropriate. Note that both of them include civil liability requirements that can see companies held liable for unlimited financial penalties without the injured party having to prove that the product actually caused the injury. This is variously known as "no-fault liability" or "strict liability", and the larger your company is, the more likely it is to be a target for no-win no-fee lawyers. Whether you complied with these directives or not is determined by a court while you are being sued. It is getting more and more difficult, I am told, for manufacturer to make a successful defence. The UK's implementation of the Product Liability directive is the 1987 Consumer Protection Act. A useful guide to this used to be found at: http://www.lowpay.gov.uk/access/consumer/intro.html. The UK's implementation of the GPSD is the 'General Product Safety Regulations 1994', and a guide used to be available at: http://www.dti.gov.uk/access/safreg94/foreword.html#1 . All the very best! Keith Armstrong www.cherryclough.com In a message dated 12/03/02 15:30:57 GMT Standard Time, [email protected] writes: > Subj:RE: ( More) Laser Safety Questions > Date:12/03/02 15:30:57 GMT Standard Time > From: [email protected] (Andrew Carson) > Sender: [email protected] > Reply-to: <A > HREF="mailto:[email protected]";>[email protected]</A> > (Andrew Carson) > To: [email protected] (Collins, Jeffrey), [email protected] > > Jeff > > In response the second part of your question on who enforces EN60825 > within Europe. If the laser device is used on a product that falls under > on of the CE (or New Approach Directives ) eg. The LVD. Then the > enforcement will be like any other CE marked goods. Which varies from > country to country, bt for the UK the CE mark is watched over by the > Depeartment of Trade and Industy and the The Office of Trading > Standards. > > Now complaice to a CE marking directive carries penalities ranging from > Finess, porduct recal and worst case upto 2 years jail time for the > person signing the DOC. The enforcement is made agaist the perosn, not > the company. > > Starngely though, if your Laser porduct does not fall under a CE > directive, there is no piece of European legistation saying it needs to > meet EN60825, beyond the old Product Safety Directive (Which does not > require a CE mark). > > In your case, if you are incororating an already CDRH registered Class 1 > device into your product without alteration. Then you do not need to re > register your overall product. This is covered by a CDRH notice to the > laser industry No. 42. > > Andrew Carson - Senior Compliance Engineer, Xyratex, UK > > Phone: +44 (0)23 9249 6855 Fax: +44 (0)23 9249 6014 > > > -----Original Message----- > From: Chris Maxwell [mailto:[email protected]] > Sent: 12 March 2002 13:22 > To: Collins, Jeffrey; [email protected] > Subject: RE: ( More) Laser Safety Questions > > > I believe that OSHA enforces the CDRH laser safety guidelines in the > workplace. I'm not sure about consumer goods...Possibly the Consumer > Product Safety Commission? > > Penalties for non-compliance would be the typical fines, recalls ... > handed out by OSHA or CPSC. > > > -----Original Message----- > > From: Collins, Jeffrey [SMTP:[email protected]] > > Sent: Monday, March 11, 2002 10:32 PM > > To: '[email protected]' > > Subject: ( More) Laser Safety Questions > > > > > > Hello Group, > > > > There was a lot of good dialog recently regarding laser safety. Thanks > > to > > all that participated!!!! > > > > Questions: > > > > Who enforces the FDA CDRH 1040.1 laser safety standards in the US? > > > > How is it enforced? > > > > What are the penalties for noncompliance? > > > > Who enforces the IEC or EN 60825 laser safety standards in Europe / > > Globally? > > > > How is it enforced? > > > > What are the penalties for noncompliance? > > > > > > My questions are stemming from the Class 1 or 1M laser safety > > requirements > > particularly in Telecom networks. > > Some NRTL's and CAB's do not require or do not enforce their clients > > doing a > > submittal ( To the FDA ) for installing these types of laser products > > in > > your equipment. Their decision was based on your company using a class > > 1 > > laser that carries a current NRTL / CAB safety certification which was > > not > > modified from it's original design when installed into your products. > > > > > > > > Thanks in advance, > > > > Jeffrey Collins > > Sr. HW Engineering Manager > > EMC/ NEBS/ Safety/ Reliability > > CIENA Core Switching Division > > 10480 Ridgeview Court, Cupertino, CA. 95014 > > (408) 366-4806, Fax (408) 366-4866 > > [email protected] > >
