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1、60601 Clause Checklist, Rev. 34 (03/2007) Medical Evaluation Package (IEC 60601-1 with National Deviations) MECA - Medical Equipment Compliance Associates, LLC (Download at http:/60601- ) Compiled by Brian R. Biersach 1 IEC 60601-1 With National Deviations (UL 60601-1, CSA C22.2 No. 601.1, EN 60601-
2、1) Company: Contact: Product Type: Phone: Model(s): Email: Ratings (V, Hz, A/W/VA, Bat.): INSULATION DIAGRAM Table: to insulation diagram Area Insulation BOP, BI, SI, DI/RI Reference voltage (V) Required creepage (mm) Required clearance (mm) Measured creepage (mm) Measured clearance (mm) Dielectric
3、Voltage (kV) Remarks A B C D E F G H I J K L M N O P 60601 Clause Checklist, Rev. 34 (03/2007) Medical Evaluation Package (IEC 60601-1 with National Deviations) MECA - Medical Equipment Compliance Associates, LLC (Download at http:/60601- ) Compiled by Brian R. Biersach 2 EVALUATION PROCEDURE: Overa
4、ll equipment description, accessories to equipment, area(s) equipment will be used , intended power supply, overall objectives MECA Project Proposal (Quote) PO # from Client to open project Anticipated date samples will be ready for testing Anticipated equipment production date UL L-37 & L-40 forms
5、signed Preliminary Evaluation: Examine equipment, discuss its use, accessories, interconnection to other equipment, construction materials Determine if collateral or particular standards are required (See list of Collateral & Particular Standards) Document Classification of equipment (Per Clause 5)
6、Examine enclosure openings (tool required to access live parts) and potential mechanical hazards, pinch points Determine potential hazards under normal use, abnormal use, Single Fault Conditions Create Insulation Diagram All components that cross a barrier (per insulation diagram) must meet creepage
7、 & clearance requirements - The working voltage of a barrier is determined by measurement - If either/both sides of barrier are floating, the highest voltages on either side of barrier are summed (except where one side 25 V) Verify power supply certification, construction and required fusing for equ
8、ipment Verify required spacings, per the Insulation Diagram Determine component requirements (UL Recognition, Electrical, Mechanical, Flame Ratings, etc.) Create test plan (See Testing Checklist) Review requirements for labels, user manual (Per Clause 6) Address any initial noncompliances Open UL Pr
9、oject (UL File #, UL Project #, UL Control #) Samples ready for testing Equipment Evaluation, Testing, Documentation Verify corrected noncompliances from Preliminary Evaluation (as applicable) Conduct full construction evaluation to standard requirements, review specifications and certificates for c
10、ritical components Conduct Initial Review with Underwriters Laboratories (Construction, documentation and test plan) Perform required testing at MECAs UL witness testing facility (or UL, when required) Verify label marking requirements Verify accompanying document requirements Review Biocompatibilit
11、y on patient contact parts, as applicable (suppliers biocompatibility information acceptable) ISO 10993-1 Software evaluation IEC60601-1-4 + ISO/IEC12207 + ANSI/UL1998, 2nd Edition. - Required if mitigating fire, shock, or mechanical hazards in N.C. and S.F.C; or if required by applicable particular
12、 standard(s) Take photographs of equipment for report (1200 x 1600 pixels minimum) Create critical component list, including all components needed to pass tests and meet the requirements of the standard Write UL Informative Test Report (CB-Style) for UL / C-UL (for US and Canada) Classification Fina
13、l review with Underwriters Laboratories UL Issue Authorization to apply the UL Mark and provides UL Report q EMC testing (Optional in US for UL Mark, required for Europe by the MDD) IEC60601-1-2 q CB Report (Optional - Required only for obtaining other Safety Marks VDE, TUV, NEMKO, SEMKO, etc.) (Not
14、 required for CE Marking) q Optional CE Marking services for sale in the European Union - Assist with your compliance documentation for the Medical Device Directive (MDD), set-up and/or work with your Notified Body, as necessary By Brian R. Biersach 60601 Clause Checklist, Rev. 34 (03/2007) Medical Evaluation Package (IEC 60601-1 with National Deviations) MECA - Medical Equipment Compliance Associates, LLC (Download at http:/60601- ) Compiled by Brian R. Biersach 3 # Resolved Issues, Noncompliances 60601 Clause Checklist, Rev. 34 (03/2007) Medical Evaluat
