Five, four, three, two, one
Medical device manufacturers are paying close attention to January 1, 2003. That's when the new safety standard for medical devices, UL 2601-1, becomes effective - making a new world of harmonized, and in many ways, more complex requirements for manufacturers product conformity assessment.  

The new standard, replacing (previous) UL standards for medical devices brings profound changes to manufacturers in terms of product design and documentation. Fueled by the push for worldwide harmonized standards, UL 2601-1 is based on the international medical device standard, IEC 60601-1, with a section for national deviations to accommodate requirements specific to the United States.  With products compliant to this new standard, manufacturers can gain access to all countries that have adopted standard IEC 60601-1 as the national standard. UL factsheet

A World of Difference 
Following are some of the important factors to consider when developing medical devices to meet the new standard UL 2601-1. 

• Particular and Collateral Standards:
  Standard UL 2601-1 requires product conformity to particular standards and collateral standards.  It's up to the manufacturer to find out which of these standards are applicable to the product.



• Product Markings:
  Because standard UL2601-1 is based on international standards,  manufacturers will need to replace any text-based product markings with the universally understood symbols of the international standard IEC 878 (Graphical Symbols for Electrical Equipment in Medical Practice).  These symbols encompass a wide range of information about the product including shock hazards, volume control, radiation levels and warnings.



• Thorough Documentation: Standard UL 2601-1 requires accompanying documentation - user manuals, transport and storage instructions, parts list, installation procedures - that contains specific information on all aspects of product operation.  Manufacturers can find the specifications for documentation requirements in both the particular standards and general 2601-1 requirements.



• Designed-in Safety: Standard UL 2601-1 directly addresses the use of the proper safety factors when performing the design calculations for suspended masses or patient supports such as an x-ray collimator or dental chair, respectively. To comply with these requirements, the manufacturer must provide design calculations for review to verify that appropriate safety factors were used as specified by the standard.



• Vitally Safe Human Contact:
  Because medical devices are used on humans, safety factors that address contact with the body are critical.  Standard UL 2601-1 requires documentation from the manufacturer verifying that no ill effects will result from any material directly contacting human tissue.  Safe contact of human tissue must now be documented according to the guidance and principles given in standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing.

The Next Step 
The message for manufacturers is clear.  If you plan to have a medical device on the international market in the Year 2003, obtain a copy of standard UL 2601-1.  Research the requirements applicable to your product. 

Contact your local ITS testing laboratory for assistance in understanding the new requirements.  And make plans now to comply with standard UL 2601-1 so you'll be ready to realize your market entry plans for January 1, 2003, and beyond.  For more information about UL 2601-1, please contact Don Sherratt at 978-263-2662, or e-mail dsherratt@itsqs.com. 

FACT SHEET   UL 2601-1 Standard for Medical Electrical Equipment,
Part I: General Requirements for Safety
 

Effective Date:	January 1, 2003
Replaces:	All previous UL standards, including Medical Devices UL 544, the Standard for Safety of Medical and Dental Equipment
Impacts:	All medical devices on the market as of January 3, 1003
Transition Period:	Products previously certified to UL 544 retain listings until January 1, 2005
Bottom Line:	Products noncompliant to UL 2601-1 will lose listings when UL 544 is withdrawn
Products Must Conform To: General requirements of standard UL 2601-1 Particular IEC standards for safety Collateral standards referred to in the general standards: IEC 60601-1-1 (Safety Requirements for Medical Electrical Systems) IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests) IEC 60601-1-3 (General Requirements for Radiation Protection in Diagnostic X-ray Equipment) IEC 60601-1-4 (Programmable Medical Electrical Systems)

Source: Marks and Markets, April 1999