The Field Inspection Process

In doing some research on the field inspection process worldwide, I came across this excellent article from Conformity magazine;

http://www.conformity.com/artman/publish/printer_226.shtml

Be sure to click on the link provided within to download a pdf, if you would like a hardcopy.

World Noise Exposure Standards - List

Here is a great listing of the noise (audible) exposure standards arround the world.  As the author points out the list is not complete, but it should serve as a great reference point from which to begin research on this topic.

http://staff.washington.edu/rneitzel/standards.htm

Japan Market Electrical Device Product Safety Information Resources

A compiled list of informational resources for importation of medical electrical devices in Japan.  This is not an all-inclusive list, but it will get you started.

Japanese Industrial Standards Committee

Japan  METI - Ministry of Economics, Trade and Industry

Japan DENAN - Electrcial Appliance and Material Safety Law

Japan PMDA - Pharmaceutical and Medical Devices Agency

Japan External Trade Organization - Information on Standards and Regulations

TUV Rheinland, Japan

The CE Marking Process

Excerpted from: BSI Website

The CE marking process

Step 1: Identify the Directive(s) that are applicable to your product. You can download these directives free of charge from the European Union website

Step 2: Identify the conformity assessment procedure that must be taken. This could be self-declaration, involve testing, inspection or quality system assessment from a Notified Body or a combination of these. The conformity assessment procedure will differ depending on your product and the Directive in respect of which you will be CE marking. If you are unsure about which procedure to take, please Contact Us for advice.

Step 3: Determine the dates by which you must take action. This will be the date that the Directive comes into force. The majority of directives are already in force. In these cases, it is an offence to place a product on the market without CE marking because it indicates a presumption of conformity with all relevant Legislation.

Step 4: Identify if there are any Harmonised European Standards applicable to your product. These are not always mandatory for manufacturers although there is a presumption that conformity to these standards will give conformity with the relevant part of the Directive. Whenever possible or appropriate, manufacturers should follow harmonised standards.

Step 5: Ensure the product complies with all the essential requirements of the Directive(s). Take appropriate measures to comply or identify existing data and test reports.

Step 6: Identify whether independent assessment of your conformity to the Directive, or some aspects of it, is required from a Notified Body. This will be stated in the directive and is dependent upon the product you are CE marking. You must not affix CE marking to your product until all necessary certifications have been obtained from the Notified Body.

Step 7: Maintain Technical Documentation required by the Directive(s). Your technical documentation should support your compliance with the requirements of the Directive. It is essential to retain this documentation.

Step 8: Prepare the Declaration of Conformity and the required supporting evidence. The Declaration of Conformity along with the Technical Documentation should be available to Competent Authorities (EU Members) upon request.

Step 9: Check that no other purely national requirements exist in the countries where the product will be sold. These may include national standards, labelling or packaging requirements.

Step 10: Affix CE marking on your product and/or its packaging and accompanying literature as stated in the directive.