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Documents
The following are documents which may be helpful to medical device manufacturers.
Reference Materials
| ID | Document | Date Posted | Description |
|---|---|---|---|
| R5 | Essential Principals of Safety and Performance Matrix Form | 15 Jul 2008, version_b | 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. |
| 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. |
| R3 | When Should I Design to IEC 60601-1, 3rd Edition? | 12 March 2007 | A White Paper by OBCM. IEC 60601-1 is the international basic safety and essential performance standard for electrical medical equipment. The current 2nd edition is IEC 60601-1: 1988 + A1:1991 + A2:1995. In December 2005 a new 3rd edition was published. Many medical device manufacturers are asking, "When's the 3rd edition effective date or transition dates?" "Should I start designing to it now?" "What's new?" "Is it harder or easier?" This paper examines these questions. There are no simple answers, but the background information you need is provided. Practical advise is offered. |
| 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 | Date Posted | Description |
|---|---|---|---|
| I5 | OBCM Service Agreement | 19 July 2007 | OBCM Service Agreement. For instructions on how to start a project with OBCM, see here. |
| I4 | OBCM 601 Seminar Registration Form | Available sometime in January | Register by fax or email using this Registration Form For seminar details, see here. |
| I3 | OBCM 601 Seminar Brochure | Available sometime in January | 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 | 19 July 2007 | Information to facilitate customers with qualification of OBCM as 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 | 7 Aug 2005 | Pdf version of OBCM Services Brochure. |