RISK MANAGEMENT IN 61010-1, THIRD EDITION
Learn about the changes and compliance requirements in IEC 61010-1 3rd Edition
www.intertek.com
Intertek
545 E. Algonquin Rd.
Arlington Heights, IL 60005
1-800-WORLDLAB
icenter@intertek.com
Risk Management In 61010-1, Third Edition
INTRODUCTION
The IEC 61010-1, 3rd Edition standard was published in June 2010. The CENELEC EN
61010-1, 3rd Edition standard was ratified in October 2010 and published in July 2011.
The CAN/CSA and UL 61010-1, 3rd 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 2nd 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January 1, 2018 – UL 61010-1 2nd edition will be withdrawn.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 3rd 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 Management In 61010-1, Third Edition
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
Electrical Shock
Clause 7
Mechanical Hazards
Clause 8
Mechanical Stresses
Clause 9
Spread of Fire
Clause 10
Temperature Limits and Resistance to Heat
Clause 11
Fluids
http://www.intertek.com/medical/electrical-testing/lab-equipment/
3
Risk Management In 61010-1, Third Edition
Clause 12
Radiation
Clause 13
Liberated Gas/Substances, Explosion, and Implosions
Clause 14
Components/Subassemblies
Clause 15
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
o
o
o
Limitation of body dimensions
Displays and indicators
Accessibility and conventions of controls
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
Risk Management In 61010-1, Third Edition
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