ࡱ>  [bjbj Jzjj684ml<L $ @@@P@lRA [jbEPF(xFxFDHdLVN"Oh$ 4O$L$L@QR>XDHDH>X>X>XRDHRDH>XO>X>XXYk"DHVE , 4@X  IEC 60601-1: Comparison Second Edition 1988 Vs Third Edition 2005 This document provides a summary of the requirements in the 3rd Edition of IEC 60601-1 related to information required to be provided in the Instructions for Use and Technical Description. It also states the level of harmony with the 2nd Edition. This document is not intended to act as a substitute for the standard but should always be use in conjunction with that document. Throughout the document, highlighted text indicates that additional information or insights related to the requirement has been provided using the NOTES feature of Word. A full analysis (all clauses) of the 3rd edition of IEC 60601-1 utilizing this format is also available from: Strategic Device Compliance Services  HYPERLINK "http://www.devicecomplance.com" www.devicecomplance.com Email:  HYPERLINK "mailto:iecsc62dsec@usa.net" iecsc62dsec@usa.net Phone: 513 236 5907 MODES OF USE This document was designed to allow manufacturers of medical electrical equipment to evaluate products certified to the Second Edition of the IEC 60601-1 standard and determine what steps are required to update that certification to the Third Edition. It is also intended to provide a tool to manage the compliance of new designs to the third edition. Finally, this document will prove useful to engineering, compliance and regulatory personnel familiar with the Second Edition become acquainted with the new Third Edition. The first two columns (3rd Edition Clause and 3rd Edition Requirement) identify the testable clause numbers in the Third Edition and provide a brief summary of the requirement. The third column (2nd Edition Clause) identifies the equivalent clause (if any) in the Second Edition and the fourth column (2nd Edition Equivalence) indicates the level of compatibility of those requirements. The fifth column (Documentation of Compliance) provides space for the design team to describe what actions will be taken to assure the requirement is met. This column also allows the design team to assign responsibility for compliance to a specific team member. The sixth column (E/NA) allows the team to identify requirements that are not applicable (NA) or that compliance was achieved by alternate methods to those specified in the standard but which still provide an acceptable level of risk equivalent (E). In either case (NA or E), an explanation should be given in the fifth (Documentation of Compliance) explaining the reason the requirement does not apply or what equivalent approach to compliance will be used. The seventh column (RMF ?) indicates those clauses of the 3rd Edition that specifically require that information be placed in the Risk Management File. However, caution should be exercised in that requirements other than those identified may require additional information be added to the Risk Management File dependent on the means used to achieve compliance. The full analysis document includes additional features not in this sample including hyper linked clause references. Contact Strategic Device Compliance Services today for pricing. 3rd Edition2nd EditionComplianceClauseRequirementClauseEquivalence LevelDocumentation of ComplianceE/NARMF ?7.9.1Documents shall accompany the equipment including at least the instructions for use and a technical description in hard copy or electronic form. The documents shall be analyzed to assure that they are written appropriately for the education, training or specialized needs of the user of the document (human factors analysis) Information provided in each accompanying document shall include at least:6.8.1SIMILAR W/ SIGNIFICANT ADDITIONSName of the manufacturer and address where they may be contacted.IDENTICALYProduct Model or Type IdentificationIDENTICALYSoftware components of programmable systems shall be identified by a revision level or date of release.IDENTICAL TO REQUIREMENTS OF 60601-1-4YRequired skills, training and knowledge of users or service personnel.NONEYEnvironmental conditions necessary for the safe use of the equipment.NONEYThe information requirements contained in IEC 60601-1-2 (EMC).IDENTICAL TO 2001 PUBLICATION OF 60601-1-2YWhere the equipment is a medical electrical system (combining two or more pieces of medical equipment OR a piece of medical and non-medical (such as a PC)), the information identified in clause  HYPERLINK \l "c16_2" 16.2 shall be provided.IDENTICAL TO REQUIREMENTS IN 60601-1-1Y7.9.2.1The instructions for use shall include at least the following:6.8.2SIMILAR W/ SIGNIFICANT ADDITIONSThe intended use/purpose of the equipment.a)IMPLICIT NOT EXPLICITThe operation and purpose of all functions related to the safety and/or essential performancea)IDENTICALContraindications where appropriate.--NONEAll classifications in clause  HYPERLINK \l "c6_2" 6.6.8.1IDENTICALA general description of the equipment and its operation.NONE7.9.2.2All markings required in clause  HYPERLINK \l "c7_2_1" 7.2 and safety signs referred to in clause HYPERLINK \l "c7_5"  7.5 or other warnings used to reduce risk shall be included in the instructions for use.6.8.1SIMILAR: 2nd Ed does not have requirements related to safety signs.For CLASS I ME EQUIPMENT, a warning statement shall be included in the instructions for use to the effect: WARNING: To avoid the risk of electric shock, this equipment must only be Connected to a supply mains with protective earth.--NONEThe instructions for use shall provide the OPERATOR or RESPONSIBLE ORGANIZATION with Warnings regarding any significant RISKS of reciprocal interference posed by the presence of the ME EQUIPMENT during specific investigations or treatments.--NONEIdentification of any applied part (patient contact surface) which can exceed 41 C.--NONE7.9.2.3Where a separate power supply (such as those containing transformer and dc conversion in a separate package and feeding dc directly into the equipment) is required, the supply shall be identified in the instructions for use as: 1) part of the equipment (the requirements of this standard apply to it also) OR 2) part of an ME System (meaning the supply can comply to another IEC standard but with appropriate isolation in the ME equipment). The supply must be specified in adequate detail to assure continuing compliance to this standard.6.8.2 h)SIMILAR: 7.9.2.4Where mains operated equipment has an alternative supply (such as battery backup) that is not automatically maintained in usable condition (for example by an automatic charging circuit), a warning shall be in the instructions indicating the appropriate action (such as regular checking and/or replacement of batteries) to assure that the equipment remains safe and that essential performance is maintained.6.8.2 e)IDENTICALIf there is a potential for leakage (that could result in an unacceptable risk) from batteries or other internal power source, warnings shall be given in the instructions to remove the source when the equipment is not in use.6.8.2 f)IDENTICALIf internal power sources (such as batteries) are replaceable, adequate specification must be given to assure proper replacement.6.8.2 g) & 10.2.2 b)IDENTICALWhere safety requires maintenance of connection to a power source, the instructions shall advise the user that this is the case.6.8.2 e)SIMILAR: 7.9.2.5The instructions shall include a description of the equipment and its modes and methods of operation.6.8.2 a)IDENTICALWhere appropriate to maintain safety a description of the intended operator and patient positions shall be described.6.8.2 a)SIMILAR: Where use of the equipment can result in exposure to materials or ingredients that could result in a risk, such materials shall be identified and the appropriate actions to mitigate risks described.6.8.2 a)SIMILAR: Where the equipment includes network or data couplings (such as Ethernet connections or RS 232 ports accessible w/o the use of a tool), restrictions to such connections necessary to maintain safety shall be identified in the instructions.6.8.2 a) e)SIMILAR:7.9.2.6Where it is necessary for the equipment to be set up, installed or configured before use, the instructions for use shall:--NONE: Provide the installation /configuration instructions--NONEIdentify the documents containing such information (including where appropriate where to acquire them)--NONEIdentify the appropriate technical personnel to perform such installation/configuration--NONE7.9.2.7Where an appliance coupler, mains plug or the like is used to fulfill the requirement that the equipment be able to be disconnected from all mains connections (see clause  HYPERLINK \l "c8_11_1" 8.11.1 a)), the instructions shall tell the user to avoid positioning the equipment such that access to the coupler, plug, etc. is limited (so that disconnection becomes difficult).--NONE7.9.2.8The instructions shall provide the operator with information necessary to safely bring the equipment into operation (such as settings, patient position, etc.).6.8.2 a)SIMILAR: 7.9.2.9The instructions for use shall contain all information necessary for the operation of the equipment within / according to its specification including explanation of all symbols, figures, warning statements, abbreviations, controls and indicator lights located on the equipment.6.8.2 a)SIMILAR7.9.2.10The instructions shall contain a list of all system, warning or error messages along with indicators signals and alarms along with an explanation of the initiating cause of each and any appropriate user action required.6.8.2 a)SIMILAR: 7.9.2.11Where appropriate the instructions shall include information necessary for the safe shut down of the equipment.--NONE7.9.2.12The instructions shall provide appropriate methods of cleaning, disinfection or sterilization for any parts or accessories (other than disposables) which may become contaminated due to patient contact (see also  HYPERLINK \l "c11_6_6" 11.6.6 &  HYPERLINK \l "c11_6_7" 11.6.7)6.8.2 d)IDENTICAL7.9.2.13The instructions shall provide the following information related to maintenance and inspection of the equipment:All inspection and maintenance intervals.6.8.2 a)IDENTICALFor inspections or maintenance performed by the user, the appropriate methods to assure continued safety.6.8.2 a)IDENTICALIdentification of parts or accessories that are to be inspected or maintained by service personnel.6.8.2 a)IDENTICALWhere equipment includes rechargeable batteries replaceable without the use of a tool, all necessary information for adequate maintenance.6.8.2 g)IDENTICAL7.9.2.14The instructions shall identify all detachable parts and accessories intended to be used with the equipment. If the equipment is intended for use as part of an ME system, the instructions shall adequately identify all system components and subsystems to assure compliance with the standard.6.8.2 a) h)SIMILAR: 7.9.2.15The instructions for use shall identify waste products, residues or the equipment itself where inappropriate disposal could result in a risk to the natural environmental. Instructions shall be given on how to minimize these risks.NONE7.9.2.16The instructions shall contain reference to the information identified in 7.9.3 (technical description) or the information itself. --NONE7.9.3.1The technical description shall include all information necessary for the safe operation of the equipment including: All information identified in clause  HYPERLINK \l "c7_2_1" 7.2.6.8.3 a)IDENTICALThe environmental conditions / restrictions for the safe use, shipping and storage of the equipment.6.8.3 d)SIMILAR: All operating characteristics of the equipment including ranges, accuracies, etc. of displayed values or information as to where they can be found)6.8.3 a)IDENTICALSpecial installation instructions necessary to keep risks acceptable.Acceptable inlet pressures, flow rates and composition of cooling liquids.--NONEWhere means to isolate the equipment from mains (in accordance with the standard) is not incorporated, the appropriate methods for achieving isolation.--NONEThe appropriate methods for checking oil levels (see  HYPERLINK \l "c15_4_9" 15.4.9)--NONEA warning that if equipment is modified, appropriate inspections and tests from this standard should be performed to assured continuing safety.--NONEWhere the technical description is separate from the instructions for use, all classifications in clause  HYPERLINK \l "c6_2" 6 and a complete description of the equipments operation/function and performance characteristics.6.8.3 a)SIMILARA brief description of the operation of the equipmentNONE7.9.3.2The technical description shall have the following information (where appropriate) regarding components:Where not apparent based on other information provided, a description of type and rating of any mains fuses.6.8.3 b)IDENTICALWhere the equipment uses a non-detachable power cord intended to be replaced by service personnel, instructions for connection and anchoring of the cord (in compliance with 8.11.3).--NONEInstructions for the replacement of components or removable parts (identified as being replaceable by service personnel)6.8.3 b)SIMILARWhere replacement of components could result in an unacceptable risk, the nature of the hazard and detailed instructions on the safe replacement.--NONE7.9.3.3A statement that the manufacturer will provide schematic diagrams, calibration information and other information necessary to perform those technical tasks identified as being able to be performed by service personnel. Where not otherwise obvious the necessary contact information shall be given.6.8.3 c)IDENTICAL7.9.3.4The technical description shall identify the method for isolating the equipment from mains power (see clause  HYPERLINK \l "c8_11_1" 8.11.1)--NONE  E stands for EQUIVALENCE indicating that alternative means were used to provide equivalent safety. Where such approaches is used, the location of justification (including data) in the Risk Management File should be identified in the compliance column.   STRATEGIC DEVICE COMPLIANCE SERVICES Global Safety, Regulatory and Standards Compliance Services For a complete version of this matrix including all testable requirements of IEC 60601-1, Edition 3 and fully featured with hyper links, contact Mike W. Schmidt of Strategic Device Compliance Services: email-  HYPERLINK "mailto:iecsc62dsec@usa.net" iecsc62dsec@usa.net phone- 513 236 5907 or visit our web site at  HYPERLINK "http://www.devicecompliance.com" www.devicecompliance.com. 2004 Strategic Device Compliance Services STRATEGIC DEVICE COMPLIANCE SERVICES Global Safety, Regulatory and Standards Compliance Services PAGE \# "'Page: '#' '" It is considered imperative that each unit include operating instructions. However, if it has been assured (through a documented procedure) that the responsible organization (purchaser of the equipment responsible for its maintenance and operation) is in possession of at least one copy of the technical description, it may not be necessary to ship a copy with each unit. Where such processes are used, they shall be addressed by the risk management process in accordance with clause 4.3 to demonstrate equivalent safety. PAGE \# "'Page: '#' '" The technical description in MOST cases is the same as a service manual. In some cases (such as those where manufacturers limit any service or repair to their own qualified experts- i.e. where the equipment is defined as not being user serviceable), it may be justifiable not to provide some technical information. In such cases, any remaining technical information (such as maintenance instructions) CAN be provided as part of the instructions for use. When this is done, all related hazards PAGE \# "'Page: '#' '" Where documents (especially the users manual) are provided electronically, the risk analysis must include the evaluation of hazards associated with unavailability of critical information. Such evaluation should determine which information should be provided 1) as separate hard copies, OR 2) as marking on the equipment. PAGE \# "'Page: '#' '" BOTH documents PAGE \# "'Page: '#' '" For each item listed below, the page or other locator (in each accompanying document) be identified in the demonstration of compliance column. PAGE \# "'Page: '#' '" Identify documents, format and human factors analyses of their writing style and content. Where documents are provided in electronic form identify the location of the analysis of associated risks. PAGE \# "'Page: '#' '" Appropriate contact information other than an address may be justified in the risk analysis in accordance with clause 4.3. PAGE \# "'Page: '#' '" While this MAY be appropriate for hardware (such as some replaceable components or subsystems), the primary purpose is to assure that the current system revision can be quickly determined. PAGE \# "'Page: '#' '" Compliance for this and the other requirements of 60601-1-2 is typically provided in the form of a certification to the requirements of that standard. However, where the manufacturer is self-certifying to that standard it is recommended that the specific pages of the accompanying documents which contain the required information is identified here. PAGE \# "'Page: '#' '" Indicate here only if the equipment is a system (see also 7.10.2.3) . Provide the documentation for compliance with the systems documentation requirements under clause 16.2. PAGE \# "'Page: '#' '" Identify locations within the instructions where the information has been placed. PAGE \# "'Page: '#' '" Essential performance is defined as aspects of operation which directly affect safety. PAGE \# "'Page: '#' '" Failure to identify contraindications is considered an indication that it is safe to use the equipment on all patients in all reasonable conditions. PAGE \# "'Page: '#' '" It is possible that this requirement is met by compliance to the other requirements of this subcaluse. PAGE \# "'Page: '#' '" Although many certification bodies insisted on this for 2nd edition compliance. PAGE \# "'Page: '#' '" The 2nd Ed. does not specifically mention systems or the requirement to put such information in the IFU. PAGE \# "'Page: '#' '" Specify whether the supply is part of the equipment or part of a system and identify where the specifications are found in the IFU. PAGE \# "'Page: '#' '" By identifying specific replacements OR by identifying all appropriate characteristics including certification to relevant standards. PAGE \# "'Page: '#' '" The 2nd Ed. only required adequate information to ensure continuing compliance after replacement. PAGE \# "'Page: '#' '" The 2nd Ed. only speaks of operation from an internal source when not connected. In most cases the requirements are identical. PAGE \# "'Page: '#' '" The 2nd Ed.s requirement to provide information necessary for safe operation was typically perceived as requiring such information although it was not specifically described. PAGE \# "'Page: '#' '" The 2nd Ed.s requirement to provide information necessary for safe operation was typically perceived as requiring such information although it was not specifically described. PAGE \# "'Page: '#' '" The 2nd Ed.s requirement to provide information necessary for safe operation was typically perceived as requiring such information although it was not specifically described. PAGE \# "'Page: '#' '" The 2nd Ed. required that the installation information be provided in the technical description only. PAGE \# "'Page: '#' '" The 2nd Ed.s requirement to provide information necessary for safe operation was typically perceived as requiring such information although it was not specifically described. PAGE \# "'Page: '#' '" This requirement for most purposes is redundant to 7.10.2.5 PAGE \# "'Page: '#' '" The second edition did not5 say according to specification but safely PAGE \# "'Page: '#' '" Again, redundant to 7.10.2.9 in most cases. Of this redundancy was created due to the inclusion of the requirements from 60601-1-4 (PEMS) PAGE \# "'Page: '#' '" Implicitly expressed not explicitly. PAGE \# "'Page: '#' '" This applies REGARDLESS of whether maintenance is performed by the user or service personnel. PAGE \# "'Page: '#' '" Where qualified service personnel are intended to perform maintenance, it is not necessary (or recommended) that instructions be given in the IFU. PAGE \# "'Page: '#' '" Identify and state maintenance cycle ONLY. PAGE \# "'Page: '#' '" While this is limited to rechargeable batteries, it would be wise to evaluate non-rechargeable ones as well (see clause 7.10.2.4 PAGE \# "'Page: '#' '" In the cases of system components OR accessories, etc. the specific components (by manufacturer name and model number) may be identified or the characteristics (specifications) including any necessary approvals may be used. PAGE \# "'Page: '#' '" The 2nd Ed. does not address systems components because 60601-1-1 was published as a separate document. PAGE \# "'Page: '#' '" While placing such information in the IFU is technically acceptable, analysis of human factors issues (such as encouraging unqualified persons to perform technical tasks should be evaluated as possible foreseeable misuse. PAGE \# "'Page: '#' '" It should be noted that while many of the items below are not specifically required by the 2nd Ed., most certification bodies would have insisted on their inclusion. PAGE \# "'Page: '#' '" Only the operating environmental conditions have been added. 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