RISK MANAGEMENT IN 61010-1, THIRD EDITION Learn about the changes and compliance requirements in IEC 61010-1 3rd Edition Intertek 545 E. Algonquin Rd. Arlington Heights, IL 60005 www.intertek.com 1-800-WORLDLAB icenter@intertek.com
INTRODUCTION The IEC 61010-1, 3rd Edition standard was published in June 2010. The CENELEC EN 61010-1, 3 rd Edition standard was ratified in October 2010 and published in July 2011. The CAN/CSA and UL 61010-1, 3 rd Edition standard was jointly published in May 2012. The changes brought into the third edition of 61010-1 were the results of a technical revision to the standard. Most notably, the 3rd Edition includes requirements for risk assessment and risk management. The scope of 61010 encompasses electrical test and measurement equipment, electrical industrial process-control equipment, and electrical laboratory equipment. Below are some of the dates of which manufacturers should be aware: August 26, 2010 IEC 61010-1, Third Edition accepted as a standard in the CB Scheme October 1, 2013 -- EU date of cessation for CENELEC EN 61010-1 2 nd edition. January 1, 2018 UL 61010-1 2nd edition will be withdrawn. This white paper leads you through the processes in Risk Assessment and Risk Management in the 3 rd edition of 61010. Learn how you can eliminate risks by taking protective measures and streamline your product design to meet compliance requirements and pave your way to global markets. http://www.intertek.com/medical/electrical-testing/lab-equipment/ 2
RISK ASSESSMENT AND RISK MANAGEMENT One of the most significant changes to IEC 61010-1 3rd Edition is the inclusion of risk assessment requirements in Clauses 16 and 17. Risk management is not entirely new to the IEC 61010 series of standards. The 2nd Edition of both IEC 61010-2-081: 2001 and IEC 61010-2-101: 2002 require manufacturers to perform risk management on the products covered by those standards. Unlike the IEC 60601-1 series of standards that mandates the use of ISO 14971 for risk management, IEC 61010-1 allows the manufacturer to choose its own method to comply with the risk management requirements, including: ISO 14971 SEMI S10-1296 IEC 61508 ISO 14121-1 ANSI B11.TR3 Annex J gives an example of how to conduct a risk assessment based on ISO/IEC Guide 51: 1999. RISK MANAGEMENT IN IEC 61010-1 3rd EDITION Clause 17 states that a risk assessment shall be conducted on hazards that are not covered by the requirements in Clauses 6 through 16 of the IEC 61010-1 standard. Clauses 6 through 15 outlined below, cover specific requirements that can occur in all types of IEC 61010-1 equipment. Clause 6 Clause 7 Clause 8 Clause 9 Clause 10 Clause 11 Electrical Shock Mechanical Hazards Mechanical Stresses Spread of Fire Temperature Limits and Resistance to Heat Fluids http://www.intertek.com/medical/electrical-testing/lab-equipment/ 3
Clause 12 Clause 13 Clause 14 Clause 15 Radiation Liberated Gas/Substances, Explosion, and Implosions Components/Subassemblies Interlocks Clause 16 documents the hazards for which a risk assessment is required: Clause 16.1 Reasonably Foreseeable Misuse : Equipment shall not present a hazard from use of the product not described in the instructions for use. Clause 16.2 Ergonomic Aspects : These aspects include, but are not limited to, the following: o Limitation of body dimensions o Displays and indicators o Accessibility and conventions of controls o Arrangement of terminals Additionally clause 17 specifies that the following process be used for risk assessment: THE RISK ASSESSMENT PROCESS IEC 61010-1 3rd Edition defines risk assessment as a three-step process: Step 1 Risk analysis Step 2 Risk evaluation Step 3 Risk reduction The risk analysis determines the hazards that could lead to a risk based upon known variables. Upon completing the risk analysis, manufacturers must perform a risk evaluation to determine if any of the risks determined are unacceptable. This evaluation is based on the manufacturer s risk acceptability criteria, which weigh the severity of the risk against the probability the risk will occur. http://www.intertek.com/medical/electrical-testing/lab-equipment/ 4
After determining which risks are unacceptable, the manufacturer must perform risk reduction to reduce the risk to an acceptable level. Risk reduction is a prioritized function in which the following are considered as the means for risk reduction: First eliminating the risk through design, if not possible Then implementing protective measures, to remove the risk, and Finally providing information to the end user via markings or instructions for use BE PREPARED Your customers have high expectations. Domestic and international distribution channels, as well as end users demand safety, reliability and rigorous compliance to existing and emerging standards. In this increasingly complex environment, you need a testing and certification partner who understands the challenges you face and has the resources and experience to help you reach global markets. By working with a testing and certification partner that has a global network of laboratories, you can be confident that you ll receive industry-leading turnaround times to help you meet compliance deadlines. Along with proactive testing and certification services, your certification partner s engineers should offer the expert guidance you need to help you navigate a complex regulatory environment and bring your laboratory equipment to market faster. For more information, or to get started on preparing for IEC 61010-1 3rd Edition, contact us at 800-WORLDLAB (800-967-5352) or at icenter@intertek.com. http://www.intertek.com/medical/electrical-testing/lab-equipment/ 5