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Documents

The following are documents which may be helpful to medical device manufacturers.

Reference Materials

ID Document Date Posted Description
R15 3rd ed compliance -- Scary Stuff? 14 Oct 11 Presentation given during our 14 Oct Open House, Shocktober.  Shows that compliance due by 1 Jun 2012 isn't so scary.
R14 Applicable Standards for Active Implants and Accessories 13 Jul 11  
R13 Presentation on how conformity assessment and fees will work for IEC 60601-1, 3rd ed 22 Mar 11 Presentation given at AAMI/FDA Standards Conference in Washington DC, on 24 Mar 2011.  Tries to "lift the fog" on conformity assessment methods to IEC 60601-1, 3rd ed.  Outlines how a manufacturer can prepare for risk management and usability engineering desk reviews, and minimize third party review fees.
R12 RMF Checklist Form 31 Jan 12, rev d An OBCM prepared form.  The purpose of this form is 2 fold:
  1. Tables 1, 2 and 3 serve to document a manufacturer's compliance with IEC 60601-1:2005, 3rd ed, Clause 4.2, which requires a Risk Management (RM) process in accordance with ISO 14971:2007, and that the RM process support the use of IEC 60601-1.
  2. Tables 1 and 3 can become an official part of a manufacturer's RMF to supplement existing hazard analysis, and relevant mitigation requirement records, especially since it speaks to the specific, and in some cases, very detailed RM information, that is needed by IEC 60601-1 in order to fulfill its test requirements. A manufacturer's RM procedures would need to make specific reference to the preparation of a relevant Table 1 and 3 like form, for it to be considered part of the manufacturer's RMF, as required by IEC 60601-1, Clause 4.2.
R11 Extra background on Essential Performance 22 Mar 2011 OBCM remarks to help in understanding the definition of Essential Performance
R10 Extra background on Reasonably Foreseeable Misuse 7 Dec 2010 OBCM remarks to help in understanding the definition of Reasonably Foreseeable Misuse
R9 OBCM observations on how Risk Management will be assessed 7 Oct 2010 OBCM observations about what seems to be the direction the international conformity assessment community is going in order to consistently evaluate electrical medical equipment to IEC 60601-1:2005, 3rd ed.  Based on CB guidance OD-2044.
R8 CB Guidance OD-2044, ed 1:2010, for RM Assessments 6 Dec 2010 IECEE Guidance document for the evaluation of RMF to the IEC 60601-1 3rd edition
R7 1 Oct 2011 Draft NB-MED guidance on effective dates, and implementation

IEC 60601-1, 3rd Edition Effective Dates

 21 Nov 2011

27 Jun 2010

 For a summary of the 3rd edition's effective dates and the impact.
R6 Presentation on medical machinery directive, and new harmonized standards (risk, usability, software, 601 3rd ed) 12 Oct 2009 Presentation explaining what's ahead with Medical Device Regulations -- Machinery Directive; Risk, Usability, and Software Harmonized Standards; Impact of IEC 60601-1, 3rd ed; What can OBCM do for you?  Give at OBCM Open House, 9 Oct 2009.
R5 Essential Principals of Safety and Performance Matrix Form 27 Jan 2010, version_d Form that can be used as design control record to show standards for which verification has been used to presume compliance with Essential Requirements of European Medical Directive(s), and the similar Essential Principals of Safety and Performance requirements outlined by Global Harmonization Task Force.  File is MS Word 1997/2003 format.

Ver d has new supplementary table for More Specific EHSR from Machinery Directive.  Per new Machinery and Medical Directive

R4 IEC 60601-1 Test Report Form for 2nd & 3rd editions 21 Dec 2011, rev k Single test report form which allows documenting compliance with both 2nd & 3rd editions of IEC 60601-1, with emphasis on 3rd edition.  2nd & 3rd edition clauses are mapped side by side.  Areas where 3rd edition clauses are new or more stringent are indicated with NEW in clause summary.  Areas where 2nd edition clauses are more stringent are indicated in a Table 4.5, Equivalent Safety, to allow opportunity to indicate 2nd edition clauses that have been verified, or those that were replace by more state of art clauses from 3rd edition.  File is MS Word 1997/2003 format.  Test Report form is a work in process.  Feedback is welcome.

Rev i has color coding so know: which requirements are more severe than 2nd ed, which require RM input according to CB guidance OD-2044, and explanation of less severe stability test requirements in Amendment 1.
R2 Why NRTL?  Why UL? Sep 2006 A Draft White Paper by OBCM examining factors motivating 3rd party certification from an OSHA accredited National Recognized Test Laboratory (NRTL).
R1 IEC 60601 3rd Edition Overview 14 Mar 2005 Copy of PowerPoint presentation about upcoming IEC 60601-1, 3rd edition, given to MassMedic meeting, 9 Mar 2005.

OBCM Information

ID Document Version Description
I7 OBCM Lab's TUV Rheinland Cert to IEC 17025 Valid 30 Nov 2010 to 30 Nov 2011,

Posted 11 Apr 2010

 TUV Rheinland Cert confirming OBCM has a compliant IEC 17025:2005 Quality Management System.  Included are Cert, and Audit Report. 

Annual audit, which supports OBCM's Partner Test Laboratory status with TUV Rheinland, allows OBCM to conduct NRLT/C testing, subject to TUV audit and review.
I6 OBCM Test Capabilities and Fees 22 May 2009 Detailed list of safety standards to which OBCM can test.  Included are rough estimates for test fees and test duration.
I5 OBCM Service Agreement On Services page, follow link OBCM Service Agreement.  For instructions on how to start a project with OBCM, see here.
I4 OBCM 601 Seminar Registration Form On-line only, see here. Register by fax or email using this Registration Form  For seminar details, see here.
I3 OBCM 601 Seminar Brochure Print web page, see here. All details about OBCM's IEC 60601-1, 3rd edition training seminar, including dates, starting times, agenda, travel arrangements, and participant requirements.
I2 OBCM Quality & Competency Print web page, see here. The OBCM About Us page includes information to facilitate customers with qualification of OBCM as a supplier of product safety consulting, testing and training services.  Included are details about laboratory capabilities, quality system, and staff experience and training.  Normally a copy of this can be filed in a supplier folder for OBCM, and it will serve as objective evidence to internal or external quality system auditors that OBCM has suitable quality and competency to provide product safety related services.
I1 OBCM Brochure out of date Print web pages: Services, About Us, Contact Us


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