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1 Oct 2013 Looms for IVD Devices in EU

posted Jul 30, 2013, 1:37 PM by Frank O'Brien   [ updated Nov 2, 2013, 1:42 PM ]
On 1 October 2013 the harmonized standard for In Vitro Diagnostic (IVD) Devices in Europe, providing a presumption of compliance with essential requirements in the In Vitro Diagnostic Medical Device (IVD MD) Directive, 98/79/EC, will be EN 61010-1:2010 (IEC 61010-1:2010), 3rd edition, along with the particular, EN 61010-2-101:2002 (IEC 61010-2-101:2002), 1st edition.  Prior to 1 October 2013 it had been acceptable to use EN 61010-1:2001 (IEC 61010-1:2001), 2nd edition, along with the particular, EN 61010-2-101:2002.  EN 61010-2-101 could be used with 2nd or 3rd ed of general standard.  We know the 3rd ed of general standard, EN 61010-1:2010, has become the harmonized standard, based on the harmonized list of standards for the Low Voltage Directive, (LVD), 2006/95/EC.  

This deadline will hold for all IVD Devices you wish to place on the European market, whether new designs or legacy (older) designs.  Any IVD Device with a CE Mark placed on the market after 1 Oct 2013 will need to comply with EN 61010-1, the 3rd edition, if harmonized standards have been used to presume compliance with essential requirements.

While risk assessment is new to EN 61010-1:2010, 3rd edition, the existing EN 61010-2-101:2002, already required a risk management process, in accordance with Annex AA (and ISO 14971:2007).  Risk management already represents the new risk assessment requirements in the new general standard, EN 61010-1:2010, Annex J.  Risk assessment doesn't require market surveillance, and it's final corrective/preventative action feedback loop, while risk management does.

However while risk management is not new to IVD Device manufacturers, when documenting compliance to the new EN 61010-1:2010, 3rd edition, in a Test Report Form, it will be new to reference the manufacturer's risk (and usability) records for the following clauses, when applicable:
  • Labeling references in clause 5.
  • Moving parts hazards, clause 7.3.3 and Table 12.
  • Resistance to Mechanical Stress, exceptions for > 1 J, < 5 J, clause 8.1
  • Flammable Liquids, clause 9.5
  • UV protection, Clause 12.3
  • Reasonably foreseeable misuse, and ergonomic factors, Clause 16
  • Risk Assessment to identify any other hazards (or where risk assessment might have been used as an alternative to standard), Clause 17

New requirements in EN 61010-1:2010, 3rd edition, that require attention include:
  • The scope now covers both professional and non-professional products.
  • Rewritten clause 6.7 and added Annex K regarding clearances, creepages, solid and thin film insulation and molded and potted parts.
  • More detailed mechanical requirements, including min protective measures for moving parts based on risk
  • Temperature requirements modified due to EN 563
  • X-ray requirements modified to include intended and non-intended emissions
  • Old clause 16 for test and measurement circuit requirements moved to a separate part 2 standard IEC 61010-2-30
  • New clause 16 for reasonably foreseeable misuse/ergonomic safety (also known as usability engineering, human factors)
  • New clause 17 for risk assessment, with risk reduction hierarchy
  • New informative section on pollution degree and microenvironments
  • New requirements for conformal coatings
  • New informative section explaining how to determine the working voltage of a mains circuit

Standards that have recently become harmonized to the IVD Medical Device Directive (27 Nov 2008; but for which your Notified Body may have allowed a 3 year transition to 27 Nov 2011) include:
  • EN 62304:2006, (IEC 62304:2006), software
  • EN 62366:2008, (IEC 62366:2007), usability engineering.

If you're an IVD device manufacturer, and need to get your technical file updated with a compliance test report for the new version of EN 61010-1:2010, we are an expert for this work.  We can also help document compliance with EN 62304:2006, software; and EN 62366:2008, usability engineering.  Be sure to contact us for any questions or a quote.