Basic Introduction To The IEC 60601 Series

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This is a preview of "AAMI CR500:2019". Click here to purchase the full version from the ANSI store.Advancing Safety in Health TechnologyAAMI Consensus ReportBasic Introduction to theIEC 60601 SeriesAAMI CR500:2019

This is a preview of "AAMI CR500:2019". Click here to purchase the full version from the ANSI store.

This is a preview of "AAMI CR500:2019". Click here to purchase the full version from the ANSI store.AAMI Consensus ReportAAMI CR500:2019Basic Introduction to the IEC 60601 SeriesAppro ved Dec em ber 2019 byAAMIAbs tract :This doc um ent provides inform ation regarding concepts and principles that underliethe IEC 60601 s eries of standards . ( The IEC 60601 series is defined in theIntroduc tion.) This doc um ent is intended to c larify and to point out the im portance ofthe s eries as w ell as to provide guidance to unders tanding and to im plem enting thes eries .Key Wordselec tromedic al equipm ent, m edic al electrical equipm ent, m edical electrical sys tem s,bas ic s afety, es s ential perform ance, risk m anagem ent

This is a preview of "AAMI CR500:2019". Click here to purchase the full version from the ANSI store.AAMI Consensus ReportA consensus report (CR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI)developed to provide concise, prompt and practical guidance on narrowly focused topics of high importance to thehealth technology community. A Consensus Report is intended provide initial consensus guidance in response to anurgent/immediate need for guidance in the following instances: While more robust data/information develops on emergent areasWhen variation in the development, implementation or use of a product or process existsWhen existing standards or other documents require additional context/clarificationA Consensus Report is not subject to the same formal process as a standard and while similar in nature to a technicalinformation report (TIR), a CR is based on the collective knowledge and experience of a selected group ofstakeholders and has not undergone the wider reviews of a TIR or standard, and offers an even greater response time.CAUTION NOTICE: This AAMI CR may be revised or withdrawn at any time. Because it addresses arapidly evolving field or technology, readers are cautioned to ensure that they have also considered information thatmay be more recent than this document.All standards, technical information reports, consensus reports and other types of technical documents developedby AAMI are voluntary, and their application is solely within the discretion and professional judgment of the userof the readoptedbygovernmentregulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcementof its rules and regulations.Comments on this technical information report are invited and should be sent to AAMI, Attn: StandardsDepartment, 901 N. Glebe Rd, Suite 300, Arlington, VA 22203.Published byAAMI901 N. Glebe Rd., Suite 300Arlington, VA 22203www.aami.org 2019 by the Association for the Advancement of Medical InstrumentationAll Rights ReservedPublication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part ofthis document without the prior written permission of the Association for the Advancement ofMedical Instrumentation is strictly prohibited by law. It is illegal under federal law (17 U.S.C. § 101, et seq.) to makecopies of all or any part of this document (whether internally or externally) without the prior written permission of theAssociation for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminalpenalties, and damages of 100,000 per offense. For permission regarding the use of all or any part of thisdocument, visit the Copyright Clearance Center.Printed in the United States of AmericaISBN 978-1-57020-733-4

This is a preview of "AAMI CR500:2019". Click here to purchase the full version from the ANSI store.ContentsPageCommittee representation . ivForeword . vIntroduction . vi1Overview of the 60601 Series . 11.1Scope and structure . 11.2The general standard . 21.3Collateral standards . 31.4Particular standards . 31.5Technical reports . 41.6U.S. national deviations . 42Demystifying the Scope of IEC 60601 . 62.1General considerations. 62.2Patient safety focus . 62.3Basic safety and essential performance . 72.3.1Basic safety . 72.3.2Essential performance. 92.3.3Regulatory perspective . 92.3.4Determining essential performance . 112.3.5Distinguishing between engineering and clinical concerns . 122.3.6Other considerations . 132.43Conformity assessment . 14Risk management and IEC 60601 . 15

This is a preview of "AAMI CR500:2019". Click here to purchase the full version from the ANSI store.Committee representationAssociation for the Advancement of Medical InstrumentationThis AAMI Consensus Report (CR) was developed by an AAMI Task Group specially formed for this project. Themembers of the task group are listed below.This CR was reviewed by the AAMI Electrical Safety Committee and the AAMI Application of risk managementto medical devices Working Group and approved by the AAMI Electrical Safety Committee.Members:Ralf Behrends, G.E. HealthcareAnthony Ciccarello, PhilipsJeffrey Eggleston, MedtronicAlex Grob, Medical Equipment Compliance AssociatesPamela Gwynn, UL LLCUwe Meyer, TUV Rheinland of North AmericaBrodie Pedersen, Borderless ComplianceRobert Phillips, Siemens HealthineersAlford Taylor, Jr., U.S. Food and Drug AdministrationJianchao Zeng, U.S. Food and Drug AdministrationNOTE—Participation by federal agency representatives in the development of this document does not constituteendorsement by the federal government or any of its agencies.iv 2019 Association for the Advancement of Medical Instrumentation AAMI CR500:2019

This is a preview of "AAMI CR500:2019". Click here to purchase the full version from the ANSI store.ForewordThis consensus-driven document was proposed as new work and developed initially by employees of the U.S. Foodand Drug Administration (FDA). A task group composed of representatives of manufacturers, testing laboratories, andaccreditation bodies met with representatives from the FDA and finalized the document.The Association for the Advancement of Medical Instrumentation (AAMI) administers the Secretariat for IECSubcommittee (SC) 62A, “Common aspects of electrical equipment used in medical practice,” and Subcommittee (SC)62D, “Electromedical equipment.”AAMI also supports the U.S. TAG (technical advisory group) for the two SCs as well as Technical Committee (TC) 62,“Electrical equipment in medical practice.”As part of the consensus-driven process of the AAMI standards program, this document was circulated for commentsto the AAMI Electrical Safety Committee and the AAMI Application of Risk Management to Medical Devices WorkingGroup. This document was also balloted for approval by the AAMI Electrical Safety Committee, the primary group thatadopts the IEC 60601-1 standard.It is hoped that this document will be useful for users of the IEC 60601 series.Suggestions for improving this document are invited. Comments and suggestions should be forwarded to the AAMIStandards Program, AAMI, 901 N. Glebe Road, Suite 300, Arlington, VA 22203. 2019 Association for the Advancement of Medical Instrumentation AAMI CR500:2019v

This is a preview of "AAMI CR500:2019". Click here to purchase the full version from the ANSI store.IntroductionThis document explores how medical device manufacturers and their stakeholders–including FDA and otherregulators–can best make use of the IEC 60601 series of safety standards to assure the safety of users/operators andpatients. This document takes a holistic and pragmatic view of the subject, starting with an examination of the conceptsand rationale underlying the development of the standards that comprise the 60601 series.The IEC 60601 series constitutes a massive and complex body of work. The original standard, IEC 601, dates to 1977.This standard has been updated and now is in its 3rd edition. This edition has been adopted as an American NationalStandard, ANSI/AAMI ES60601-1, which runs over 400 pages. Eight collateral standards add requirements havinggeneral (horizontal) applicability to all medical electrical equipment (MEE) or medical electrical systems (MES) withinthe scope, covering such topics as alarm safety, radiation protection, and the use of medical equipment in the homeand emergency medical service environments. The vertical or device-specific particular standards provide safety andperformance requirements for specific types of medical electrical equipment or medical electrical systems. The generalstandard normatively references close to 50 ISO and IEC standards, and informatively references an additional 70-plusstandards1. In a subsequent section, we will go into greater detail about the structure and organization of the series.IEC Technical Committee (TC) 62, Electrical equipment in medical practice, is responsible for the care and maintenanceof the IEC 60601 series. Within TC 62, there are 4 subcommittees, with given responsibilities as outlined below. Thesubcommittees head up 80 or more working groups, maintenance teams, joint working groups, and advisory boardsworking on different aspects of the committee’s program.-SC 62A, “Common aspects of electrical equipment used in medical practice” (responsible for general andmost of the collateral standards along with related documents for horizontal issues)SC 62B, “Diagnostic imaging equipment” (responsible for 60601-1-3 and particular standards and relateddocuments in the subject matter of imaging equipment)SC 62C, “Equipment for radiotherapy, nuclear medicine and radiation dosimetry” (responsible for particularstandards and related documents in the subject matter)SC 62D, “Electromedical equipment” (responsible for particular standards that have not been covered by theother three SCs)Given the size and complexity of this body of work, it is a challenge to gain more than a superficial understanding ofwhat the 60601 series of standards encompasses, let alone why it matters. Therefore, a key objective of this documentis to provide stakeholders with sufficient information about the 60601 series to grasp its significance and value. At thesame time, it is important to know what the 60601 series excludes, so that stakeholders can understand the role it playsin the broader context of assuring the safety and effectiveness of MEE/MESs.1Normatively referenced standards are the basis for the associated requirements in 60601-1. Informative references are forinformation only.vi 2019 Association for the Advancement of Medical Instrumentation AAMI CR500:2019

adopts the IEC 60601-1 standard. It is hoped that this document will be useful for users of the IEC 60601 series. Suggestions for improving this document are invited. Comments and suggestions should be forwarded to the AAMI Standards Program, AAMI, 901 N. Glebe Road, Suite 300, Arl

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