AAMI ES 60601-1 pdf free download

AAMI ES 60601-1 pdf free download.DATA ACCEPTANCE PRC GRAM.
Procedure for Use of ANSI/AAMI ES 60601-1:2005 and ANSI/AAMI ES 60601- 1:2005 & A1:2012 Non-Standard Test Methods (typically defined by a Risk Management Process) Responsibility – DAP Assessment Personnel† Qualified DAP Personnel is to confirm compliance with the following Clauses of ISO 1 7025 during the annual DAP assessment of the test laboratory: · 5.4.4 – Non-standard methods · 5.4.5 – Validation of test methods Verification of compliance with these clauses is to be included in the DAP annual assessment records for the test laboratory. †DAP Assessment Personnel may include Lead Auditor and Technical Auditor, as applicable. Responsibility – Manufacturer/Test Laboratory The written documentation providing technical justification and validation of the non-standard test methods and the authorization and acceptance from UL CAS Personnel prior to testing is to be recorded in the Manufacturer’s device history file. The test laboratory (if different than the manufacturer) will need to have access to these records for review during the annual DAP assessment. NOTE (Informative): Since the technical justification for the use of non-standard test methods would target a specific product, it is encouraged that the Risk Management requirements of ISO 1 4971 are fully implemented prior to development of the technical justification.UL ASSUMES NO RESPONSIBILITY FOR ANY OMISSIONS OR ERRORS OR INACCURACIES WITH RESPECT TO THIS INFORMATION. UL MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO THE ACCURACY, CONDITION, QUALITY, DESCRIPTION, OR SUITABILITY OF THIS INFORMATION, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND EXPRESSLY DISCLAIMS THE SAME.If the justification is found acceptable, CAS Personnel shall provide written authorization and acceptance to the manufacturer/test laboratory prior to testing and update the client laboratory’s scope of participation accordingly. The non-standard test a method technical justification shall be documented in the 60601 -1 TRF as Objective Evidence (records) for the applicable ISO 1 4971 and ISO 1 7025 clauses. Datasheet packages submitted for UL certification shall document the non-standard test method and other applicable requirements to comply with UL’s Data Recording & Reporting Requirements.The manufacturer/test laboratory shall provide CAS Personnel written documentation providing technical justification for application of the previously reviewed non-standard test method(s) to the device in question. CAS Personnel shall review the documentation to determine: · Compliance with Clause 4.2 of ISO 1 4971 following the technical discussion process documented in the Guidance Document 00-HS-G0400. That is, an assessment shall be made to determine, through review of the Risk Management File, the appropriate application of the non-standard test method to insure safety and essential performance of the device in question. If application of the non-standard test method to the device in question is found acceptable, CAS Personnel shall provide written authorization and acceptance to the manufacturer/test laboratory prior to testing. The non-standard test method technical justification and validation shall be documented in the 60601 -1 TRF as Objective Evidence (records) for the applicable ISO 1 4971 and ISO 1 7025 clauses. Datasheet packages submitted for UL certification shall document the non-standard test method and other applicable requirements to comply with UL’s Data Recording & Reporting Requirements.AAMI ES 60601-1  pdf download.