03 May 2013

Products being sold into the EU must comply with the 3rd edition of CENELEC EN 61010-1 by October 2013.

I am constantly being asked by many in the medical device industry: "Why should I be concerned with the new edition of 61010-1, Third Edition?

CENELEC and IEC 61010-1: 2010, Third Edition – along with CSA and UL 61010-1 Third Edition, 2012 "Safety requirements for electrical equipment for measurement, control, and laboratory use" – is the internationally harmonized safety standard for laboratory, process control, and test & measurement equipment. Products sold into the EU must comply with the 3rd edition of CENELEC EN 61010-1 by October 2013. Let's take a closer look at the scope of the standard and some of the major changes to 61010 Third Edition:

Scope of 61010-1 Third Edition:

  • The scope of the standard is expanded to cover the following types of equipment – regardless of where these products may be used.
    • Electrical test and measurement equipment
    • Electrical laboratory equipment
    • Electrical industrial process-control equipment
    • Note: Hand-held probe assemblies are no longer covered IEC 61010-1; a new standard IEC 61010-031 has been created.
  • The transition date for the EU is October 1, 2013. Compliance with CENELEC EN 61010 3rd Edition will be mandatory for products needing to comply with the low voltage directive for CE marking in accordance with the European Union. The CB Scheme accepted IEC 61010-1 on August 2010. In North America, UL has announced that the effective date for 61010-1 third edition is January 1, 2018. CSA currently has not announced an effective date for 61010-1 third edition.

The major changes to the standard include:

  • Clause introduces the requirements for red pushbuttons and indictors
  • Clause 6.7 and Annex K covers the new requirements for insulation, including air clearance and creepage distances
  • Clause 7.3 introduces the new requirements for moving parts, which include risk assessment requirements
  • Clause 7.3.5 introduces the requirements on gap limitations for moving parts
  • Clause 7.5.3 adds requirements for load testing on parts of equipment supporting heavy loads
  • Clause 8.1 introduces the term normal energy protection level and the requirements for using a lower level than specified in the standard
  • Clause 10.1 has modified the requirements for surface temperature limits.
  • Clause covers the requirements for equipment intended to emit radiation
  • Clauses 16 (Reasonably Foreseeable Misuse / Ergonomics) and Clause 17 (Risk not covered by the standard) introduce the new requirements for risk assessment

The changes to the standard should be understood by many different functions within your company including compliance, design, engineering, regulatory and marketing.

Want to learn more on these topics? Check back as these topics are explored in more detail over the coming weeks.

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