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

Updated Guidance On The New EMC Directive

This Guide has been structured in a logical way suitable for users who need to ensure that their equipment is in conformity with the EMC Directive. It is divided into the following Chapters:

1. Scope:  Allows manufacturers or others to quickly decide whether their equipment falls under the scope of the EMC Directive and if so, if it is apparatus or a fixed installation.
2. Essential requirements provide an overview of the mandatory requirements.
3. Conformity assessment procedure for apparatus: gives information including: the usual steps of an EMC assessment; information and documentation requirements; EC Declaration of Conformity and CE marking. 
4. More detailed guidance is provided for an EMC assessment where harmonised standards are not used or do not cover all protection requirements.
5. Procedures for fixed installations: on the relevant requirements and documentation needed for fixed installations, including the use of apparatus specifically for incorporation into a given fixed installation.
6. Enforcement of the EMC Directive: relates to the duties of the national competent authorities in ensuring only compliant apparatus circulated in the Community, with further information on apparatus intended for demonstration at trade-fairs. In parallel, to ensure that fixed installations meet the essential requirements.
7. Notified Bodies: their role, selection, coordination and the treatment of complaints.

Click HERE to access or download the guide.

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