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Documents
The following are documents which may be helpful to medical device manufacturers.
Reference Materials
| ID | Document | Date Posted | Description |
|---|---|---|---|
| R7 | When Should I Design to IEC 60601-1, 3rd Edition? | 27 Jun 2012 | For a summary of the 3rd edition's effective dates and the impact, see https://docs.google.com/a/obcompman.com/Doc?docid=0AWHRGv-ISZrrZHQ3ejU1Yl8yNDlnZ3BiemtkZw&authkey=CJC0gJkH&hl=en. |
| R6 | What's ahead for Medical Device Regulation? | 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 | 15 Jul 2008, version_g | 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. |
| 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 |
|---|---|---|---|
| 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 | 28 Mar 2009 | 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 |