Advantech to conform to IEC 60601-1 standard third edition changes

Advantech says it will conform to the new third edition changes to the IEC 60601-1 standard, a family of standards that applies to safe equipment operation in medical environments.

The updated standards apply the principles of risk management in accordance with ISO14971 into the design process, ensuring higher safety and reliability is achieved.

The POC-227 point-of-care terminal is the first of its medical computing products to comply with EN 60601-1:2006, and the company will bring all its relevant products into conformance with the standard.

The IEC 60601-1 standard is a globally recognised standard for electro-medical equipment safety and a parent standard over 60 particular device standards.

The third edition, issued in 2005, has a compliance date of June 2012 for the European market (EN 60601-1:2006) and July 2013 for the US market under FDA and OSHA regulations (ANSI/AAMI ES60601-1:2005), and is radically different from the preceding, second edition standards.

One addition is a clause to conform to the ISO14971 regulations for risk management. This ISO regulation establishes requirements for the manufacturer to employ risk management in determining the safety of a medical device during its product life cycle.

IEC 60601-1 3rd Edition has several other updated regulations concerning: general requirements for medical devices; standards for identification, marking and providing accompanying documents; hazards (electrical, mechanical, radiation, temperature and fire, accuracy, etc); and hazardous situations and fault conditions.