IEC 60601-1 Testing

IEC 60601-1 Testing

Medical Safety IEC 60601-1, 3rd Edition

The IEC 60601-1 standard is a globally recognized standard for electro-medical equipment safety, and a parent standard over 60 particular device standards. The third edition (3rd), 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 (2nd) standard.

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. The purpose of these rules is to ensure that equipment manufacturers have safety, performance, and risk management control measures in place.

 IEC 60601-1 3rd Edition Mandatory Adoption Dates

• Europe: June 1, 2012

• Canada: June 1, 2012

• USA: July 1, 2013

 European Union (EU)

• The date of withdrawal (DOW) for EN 60601-1 2nd Edition is June 1, 2012

• The DOW means that all products sold in the EU after that date shall conform to the requirements of the new standard

• However, this DOW (June 1, 2012) for medical devices is only for the Part 1 standard, EN 60601?1

• For medical devices with relevant particular (Part 2) standards, the DOW has to be checked

• With 50+ particular (Part 2) standards (IEC/EN 60601-2) currently referencing specific clauses in the 2nd Edition, the DOW for medical devices with particular (Part 2) standards, will not be set until the particular (Part 2) standard has been updated with references to specific clauses in the 3rd edition

• The transition period for medical devices with particular (Part 2) standards will be extended as necessary (generally 3 years after DOP)

• Some Part 2 standards harmonized with 3rd edition are numbered IEC/EN 80601

 USA

• Published by AAMI (Association for the Advancement of Medical Instrumentation) as ES 60601-1 (not published by UL!)

• AAMI is working to resolve the national deviations and a revision or notice will be published

• FDA has published ES 60601-1 3rd edition to List of Recognized Standards; transition date set for July 1, 2013

• Currently both 2nd edition and 3rd edition is accepted in USA

• Expected that NRTLs will allow grandfather of 2nd Edition into the future (unlike EU)

CANADA

• Published by CSA as CAN/CSA C22.2 No. 60601-1:2008

• Health Canada has published IEC 60601-1 3rd edition to List of Recognized Standards; transition date set for June 1, 2012

• Currently both 2nd edition and 3rd edition is accepted in Canada

• Expected that NRTLs will allow grandfather of 2nd Edition into the future (unlike EU)

4-Step Process to IEC 60601-1 Certification

Developing a Risk Management File (RMF) to meet 3rd Edition certification is a new challenge for manufacturers. The process consists of:

1. Education: How to be compliant to the 3rd Edition

2. Audit to ISO 14971: Increase your Risk Management pass rate up to 80%

3. Preliminary Design Package: Includes preliminary reviews of the product and the Risk Management File

4. Testing & certification to IEC 60601-1 3rd Edition.

 IEC 60601-1 Support Services

• Training: Customized on-site or off-site training options

• Certification: NRTL (U.S./Canada) & MDD (European Medical Device Directive)

IEC 60601-1 2nd to 3rd Edition Transition Services

For products that have already been certified to the 2nd Edition of IEC 60601-1, G&M offers the fastest route to 3rd Edition compliance.

• Gap Analysis

• Risk Management File Review

• Risk Management Systems Auditing & Certification: ISO 14971

IEC 60601-1 is accepted throughout the world through the IECEE CB Scheme. Listed below are all of the countries that accept IEC 60601-1.

• Argentina

• Australia

• Austria

• Bahrain

• Belarus

• Belgium

• Brazil

• Bulgaria

• Canada

• China

• Colombia

• Croatia

• Czech Republic

• Denmark

• Finland

• France

• Germany

• Greece

• Hungary

• India

• Indonesia

• Iran, Islamic Republic Of

• Ireland

• Israel

• Italy

• Japan

• Kazakhstan

• Kenya

• Korea, Republic Of

• Libyan Arab Jamahiriya

• Malaysia

• Mexico

• Netherlands

• New Zealand

• Norway

• Pakistan

• Poland

• Portugal

• Romania

• Russian Federation

• Saudi Arabia

• SerbiaSingapore

• Slovakia

• Slovenia

• South Africa

• Spain

• Sweden

• Switzerland

• Thailand

• Turkey

• Ukraine

• United Arab Emirates

• United Kingdom

• USA

• Viet Nam