SDCS60601 1 6Report

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SDCS60601 1 6Report Powered By Docstoc
					                   Commission Electrotechnique Internationale
                   International Electrotechnical Commission
                   Secretary IEC/SC 62D




                            S T R A T E GI C D E V I C E C OMP L I A NC E S E R V I C E S
                            S T R A T E GI C D E V I C E C OMP L I A NC E S E R V I C E S
                      Glloball Saffety,, Regullatory and Standards Complliiance Serviices
                      G oba Sa ety Regu atory and Standards Comp ance Serv ces

                                                             IEC 60601 - 1- 6
                                            Medical electrical equipment
                      Part 1-6: General requirements for safety - Collateral Standard: Usability


Report Reference No. ...................... :
Compiled by (+ signature) ................ :                                    .....................................................
Approved by (+ signature) ................ :                                    .....................................................
Date of issue..................................... :


Applicant’s name ............................ :
Address ............................................ :


Test specification:
Standard ........................................... :    IEC 60601-1-6: 2006


Test item description ..................... :
Trade Mark ....................................... :
Manufacturer .................................... :
Model/Type reference....................... :
Ratings ............................................. :


Possible test case verdicts:
- test case does not apply to the test object.................. : N/A
- test object does meet the requirement ....................... : Pass (P)
- test object does not meet the requirement ................. : Fail (F)




IEC 60601-1-6                                                                                        Page 1 of 5
            Commission Electrotechnique Internationale
            International Electrotechnical Commission
            Secretary IEC/SC 62D




                    S T R A T E GI C D E V I C E C OMP L I A NC E S E R V I C E S
                    S T R A T E GI C D E V I C E C OMP L I A NC E S E R V I C E S
                Glloball Saffety,, Regullatory and Standards Complliiance Serviices
                G oba Sa ety Regu atory and Standards Comp ance Serv ces


Clause      Requirement + Test                                                          Result - Remark            P/F/NA
4           General requirements
4.1         EQUIPMENT provides adequate USABILITY, and the
            RISKS resulting from NORMAL USE and USE ERRORS are
            acceptable
4.2         Risk analyses shall incorporate/consider the
            following:
            – application specification
            – OPERATOR PROFILE;
            – predictable USE ERRORS
            – * task related requirements;
            – * context of use;
            – information on HAZARDS known for existing
            OPERATOR-EQUIPMENT INTERFACES for ME EQUIPMENT
            of a similar type
            – results of the review of the OPERATOR-EQUIPMENT
            INTERFACE

5           IDENTIFICATION, MARKING AND DOCUMENTS
5.1         ACCOMPANYING DOCUMENTS                                                      See Attachment #
            A brief description of EQUIPMENT, its physical
            operating principles, and significant physical and
            performance characteristics relevant to its USABILITY
            included in the instructions for use
            The same information, when provided as a separate
            document, included in the technical description
            ACCOMPANYING DOCUMENTS for equipment are,
            optionally, provided electronically, e.g., by electronic
            file format or CD-ROM ................................................. :
            USABILITY ENGINEERING PROCESS includes the
            information that will need to be provided as a hard
            copy or as markings on EQUIPMENT (e.g., to cover
            emergency operation) when ACCOMPANYING
            DOCUMENTS are provided electronically

            ACCOMPANYING DOCUMENTS include a description of
            the OPERATOR PROFILE
            ACCOMPANYING DOCUMENTS are written at a level
            consistent with the intended OPERATOR PROFILE
5.2         Necessary TRAINING materials provided in the                                See Attachment #
            instructions for use when EQUIPMENT specific
            TRAINING is required for PRIMARY OPERATING
            FUNCTIONS of EQUIPMENT;


IEC 60601-1-6                                                                                              Page 2 of 5
            Commission Electrotechnique Internationale
            International Electrotechnical Commission
            Secretary IEC/SC 62D




                     S T R A T E GI C D E V I C E C OMP L I A NC E S E R V I C E S
                     S T R A T E GI C D E V I C E C OMP L I A NC E S E R V I C E S
                Glloball Saffety,, Regullatory and Standards Complliiance Serviices
                G oba Sa ety Regu atory and Standards Comp ance Serv ces


Clause      Requirement + Test                                                               Result - Remark            P/F/NA
            – instructions for use indicate and ensure TRAINING
            materials are available; or
            – the manufacturer provides TRAINING
            EQUIPMENT-specific TRAINING provides knowledge
            and skills required for safe and effective use of
            EQUIPMENT in addition to the OPERATOR PROFILE

            INTENDED USE/INTENDED PURPOSE is the basis for
            TRAINING and TRAINING material

            Instructions for use indicate the available TRAINING
            options and when specific TRAINING for the
            EQUIPMENT is required

6           USE ERROR AND USABILITY
6.1         A USABILITY ENGINEERING PROCESS related to
            USABILITY of OPERATOR-EQUIPMENT INTERFACE was
            conducted to provide SAFETY for PATIENT, OPERATOR,
            and other persons
6.2.1       Results of the USABILITY ENGINEERING PROCESS                                     See Attachment #
            recorded in the USABILITY ENGINEERING FILE
            Records and other documents making up the                            See Attachment #
            USABILITY ENGINEERING FILE form a part of other
            documents and files such as manufacturer’s product
            file or RISK MANAGEMENT FILE ..................................... :
            When design of existing EQUIPMENT was modified,                                  See Attachment #
            USABILITY ENGINEERING PROCESS was scaled based
            on the significance of the modification, and
            depending on the results of the RISK ANALYSIS
6.2.2.1     Application of the EQUIPMENT is specified in the                                 See Attachment #
            USABILITY ENGINEERING FILE, and the specifications
            include the following information:
            – medical purpose such as conditions(s) or
            disease(s) to be screened, monitored, treated, or
            diagnosed .................................................................. :
            – PATIENT population such as age, weight, region of
            body, health, and condition........................................ :
            – part of the body or type of tissue applied to or
            interacted with............................................................ :
            – intended OPERATOR PROFILE ................................... :
            – application such as environment, frequency of use,
            location, and mobility ................................................. :

IEC 60601-1-6                                                                                                   Page 3 of 5
            Commission Electrotechnique Internationale
            International Electrotechnical Commission
            Secretary IEC/SC 62D




                   S T R A T E GI C D E V I C E C OMP L I A NC E S E R V I C E S
                   S T R A T E GI C D E V I C E C OMP L I A NC E S E R V I C E S
                Glloball Saffety,, Regullatory and Standards Complliiance Serviices
                G oba Sa ety Regu atory and Standards Comp ance Serv ces


Clause      Requirement + Test                                        Result - Remark            P/F/NA
            A summary of the EQUIPMENT application
            specification is included in the instructions for use
6.2.2.2     PRIMARY OPERATING FUNCTIONS are recorded in the           See Attachment #
            USABILITY ENGINEERING FILE

6.2.2.3     Information on safety for RISK CONTROL relative to        See Attachment #
            USABILITY such as warnings or limitation of use are
            included in ACCOMPANYING DOCUMENTS, markings,
            and the like, and were subjected to the USABILITY
            ENGINEERING PROCESS

6.3         USABILITY SPECIFICATION developed by the                  See Attachment #
            manufacturer is recorded in USABILITY ENGINEERING
            FILE, and integrated into other specifications

            USABILITY SPECIFICATION is based on the following:
            – application specification
            – HAZARDS related to the use of EQUIPMENT (results
            from RISK ANALYSIS in 46.202.2.3)
            – predictable USE ERRORS associated with EQUIPMENT
            USABILITY SPECIFICATION describes at least the
            following:
            – USE SCENARIOS for EQUIPMENT
            – OPERATOR actions related to PRIMARY OPERATING
            FUNCTIONS

            – OPERATOR-EQUIPMENT INTERFACE requirements for
            PRIMARY OPERATING FUNCTIONS
            – requirements to determine if PRIMARY OPERATING
            FUNCTIONS are easily recognizable by the OPERATOR
6.2.4       Manufacturer verified the OPERATOR-EQUIPMENT              See Attachment #
            interface design according to the USABILITY
            SPECIFICATION, and the results of the verification are
            recorded in the USABILITY ENGINEERING FILE
46.202.5    Manufacturer has developed and maintains a                See Attachment #
            USABILITY VALIDATION plan specifying the following:

            – method used for VALIDATION of the USABILITY of
            PRIMARY OPERATING FUNCTIONS

            – criteria for determining successful VALIDATION of the
            USABILITY of PRIMARY OPERATING FUNCTIONS

            – involvement of representative intended OPERATORS


IEC 60601-1-6                                                                            Page 4 of 5
            Commission Electrotechnique Internationale
            International Electrotechnical Commission
            Secretary IEC/SC 62D




                     S T R A T E GI C D E V I C E C OMP L I A NC E S E R V I C E S
                     S T R A T E GI C D E V I C E C OMP L I A NC E S E R V I C E S
                Glloball Saffety,, Regullatory and Standards Complliiance Serviices
                G oba Sa ety Regu atory and Standards Comp ance Serv ces


Clause      Requirement + Test                                                               Result - Remark            P/F/NA
            Quantitative or qualitative method used for USABILITY
            VALIDATION ................................................................. :

            USABILITY VALIDATION performed in a laboratory
            setting, in a simulated use environment, or in the
            actual use environment ............................................. :
            USABILITY VALIDATION plan addresses the following:
            – worst case USE SCENARIOS derived from the
            application specification, predictable USE ERRORS,
            and results of the RISK ANALYSIS
            – USE SCENARIOS representing frequent application                                See Attachment #
            situations identified in the USABILITY SPECIFICATION
            USABILITY VALIDATION plan is recorded in the                                     See Attachment #
            USABILITY ENGINEERING FILE

6.2.6       Manufacturer validated OPERATOR-EQUIPMENT                                        See Attachment #
            INTERFACE design according to USABILITY VALIDATION
            plan, and the results, including the required design
            modifications to satisfy the criteria in the USABILITY
            VALIDATION plan, are recorded




IEC 60601-1-6                                                                                                   Page 5 of 5

				
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