IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment, published by the International Electrotechnical Commission

International Electrotechnical Commission

The International Electrotechnical Commission is a non-profit, non-governmental international standards organization that prepares and publishes International Standards for all electrical, electronic and related technologies – collectively known as "electrotechnology"...

. First published in 1977 and regularly updated and restructured, it is made up, as of 2011, of a general standard, about 10 collateral standards, and about 60 particular standards.

General standard

The general standard IEC 60601-1 - Medical equipment|medical electrical equipment - Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a de-facto requirement for the commercialization of an electrical medical equipment in many countries. Many companies view compliance with IEC 60601-1 as a de facto requirement for most markets.

National deviations

National deviations of this series of standards exist which include country specific requirements; see e.g. UL

Underwriters Laboratories

Underwriters Laboratories Inc. is an independent product safety certification organization. Established in 1894, the company has its headquarters in Northbrook, Illinois. UL develops standards and test procedures for products, materials, components, assemblies, tools and equipment, chiefly dealing...

 or AAMI

Association for the Advancement of Medical Instrumentation

The Association for the Advancement of Medical Instrumentation founded in 1966, is a voluntary consensus organization which promotes knowledge and use of medical instrumentation. It creates standards, educates and certifies technicians, and publishes technical documents, books, periodicals, and...

 for US specifics.

Revisions

In 2005, the third edition of IEC 60601-1 was published. It was the result of a comprehensive review of the second edition (dating from 1988). Some key changes are: the outline and the numbering scheme of the clauses and subclauses were changed, risk management was made much more relevant and the concept of essential performance was added. Currently (2011), the applicability of the second and third edition is somehow overlapping depending on the products under consideration and the country/area of application.

Collateral and particular standards

Requirements of 60601-1 may be overridden or bypassed by specific language in the standards for a particular product.
Collateral standards (numbered 60601-1-X) define the requirements for certain aspects of safety and performance, e.g. Electromagnetic Compatibility (IEC 60601-1-2) or Protection for diagnostic use of X-rays (IEC 60601-1-3).
Particular standards (numbered 60601-2-X) define the requirements for specific products, e.g. MR scanners (IEC 60601-2-33) or Electroencephalograms (IEC 60601-2-26). .
Collaterals and Particulars may have their own revisions which are different from the General Standard.

Example

IEC 60601-1-9 for Environmentally Conscious Design of Medical Electrical Equipment

Medical equipment

Medical equipment is designed to aid in the diagnosis, monitoring or treatment of medical conditions.-Types:There are several basic types:* Diagnostic equipment includes medical imaging machines, used to aid in diagnosis...

 published July 2007 is a collateral standard

Standardization

Standardization is the process of developing and implementing technical standards.The goals of standardization can be to help with independence of single suppliers , compatibility, interoperability, safety, repeatability, or quality....

 to IEC 60601-1 and has been developed drawing on extensive practical experience at Philips Medical Systems and Siemens Medical Solutions

Siemens Medical Solutions

Siemens Healthcare is a supplier to the healthcare industry, and is headquartered in Erlangen, Germany. Prior to being acquired by Siemens in 2000, the company was known as Shared Medical Systems Corporation and traded on the New York Stock Exhange as "SMS"...

. The Part 9 standard asks manufacturers of medical devices to consider the environmental impacts of their devices throughout the product's entire life cycle

Product life cycle management

Product life-cycle management is the succession of strategies used by business management as a product goes through its life-cycle. The conditions in which a product is sold changes over time and must be managed as it moves through its succession of stages.Product life-cycle Like human beings,...

 and to minimise these where possible. The standard also requires that the manufacturer provide information to the user on how to use the product in the most environmentally sensitive way.
The USA

United States

The United States of America is a federal constitutional republic comprising fifty states and a federal district...

, Canada

Canada

Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...

, Japan

Japan

Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...

, Australia

Australia

Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...

 and New Zealand

New Zealand

New Zealand is an island country in the south-western Pacific Ocean comprising two main landmasses and numerous smaller islands. The country is situated some east of Australia across the Tasman Sea, and roughly south of the Pacific island nations of New Caledonia, Fiji, and Tonga...

have not yet set transition dates for their national versions of this latest edition 60601-1, but the national versions published to date do contain the requirement to also conform with IEC 60601-1-9. However, the European version (EN 60601-1:2006) requires compliance with the new IEC 60601-1-9 collateral standard by September 2009.