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reviews of a TIR or standard, and offers an even greater response time.CAUTION NOTICE: This AAMI CR may be revised or withdrawn at any time.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
May 02, 2018 · D. Program Evaluation ͟The organization has provided a description of the framework for how each program will be evaluated. The framework should include all the elements below: ͟The evaluation methods are cost-effective for the organization ͟Quantitative and qualitative data is being collected (at Basics tier, data collection must have begun)
IEC 61215 IEC 61730 PV Modules Manufacturer IEC 62941 IEC 62093 IEC 62109 Solar TrackerIEC 62817 PV Modules PV inverters IEC 62548 or IEC/TS 62738 Applicable Standard IEC 62446-1 IEC 61724-1 IEC 61724-2 IEC 62548 or IEC/TS 62738 IEC 62548 or IEC/TS 62738 IEC 62548 or IEC/TS 62738 IEC 62548 or IEC/
On an exceptional basis, Member States may request UNESCO to provide thé candidates with access to thé platform so they can complète thé form by themselves. Thèse requests must be addressed to esd rize unesco. or by 15 A ril 2021 UNESCO will provide thé nomineewith accessto thé platform via their émail address.
IEC has formed IECRE for Renewable Energy System verification - Component quality (IEC 61215, IEC 61730, IEC 62891, IEC 62109, IEC 62093, IEC 61439, IEC 60947, IEC 60269, new?) - System: - Design (IEC TS 62548, IEC 60364-7-712, IEC 61634-9-1, IEC 62738) - Installation (IEC 62548, IEC 60364-7-712)
IEC 61869-9, IEC 62351 (all parts), IEC 62439-1:2010, IEC 62439-3:2010, IEC 81346 (all parts), IEC TS 62351- 1, IEC TS 62351- 2, IEC TS 62351- 4, IEC TS 62351- 5, Cigre JWG 34./35.11, IEC 60044 (all parts), IEC 60050 (all parts), IEC 60270:2000, IEC 60654-4:1987, IEC 60694:1
Chính Văn.- Còn đức Thế tôn thì tuệ giác cực kỳ trong sạch 8: hiện hành bất nhị 9, đạt đến vô tướng 10, đứng vào chỗ đứng của các đức Thế tôn 11, thể hiện tính bình đẳng của các Ngài, đến chỗ không còn chướng ngại 12, giáo pháp không thể khuynh đảo, tâm thức không bị cản trở, cái được
The new IEC 61439 series is expected to have a similar structure to IEC 60439 with several new additions*: IEC 60439 IEC 61439 Series IEC 61439-1 General rules IEC 61439-2 Power switchgear and controlgear assemblies IEC 61439-6 Busbar trunking systems IEC 61439-3 Distribution boards IEC 61439-4 Assemblies for construction sites IEC 61439-5
IEC 61968-4 IEC 61968- 6 IEC 61968-7 IEC 61968-8 IEC 61968-9 Applicable parts of IEC 61968 Series Network Operation (NO) IEC 61968-3 Operational Planning & Optimization (OP) IEC 61968-5 Bulk Energy Management (EMS) IEC 61970 & Applicable parts of IEC 61968 Series External Systems: Customer Account Management (ACT) Financial (FIN) Business .
IEC 60634-1 IEC 60050-826 IEC 60364-4-41 IEC 60364-4-42 IEC 60364-5-52 IEC/DIS 64(CO)9173 IEC 60204-32 IEC 60529-1989; IEC 60529 IEC 60529 Accident prevention regulation "Electrical systems and apparatus" Accident prevention regulatio
IEC 60034-7 IEC 60034-8 IEC 60034-9 IEC 60034-11 IEC 60034-12 IEC 60034-14 IEC 60034-30 IEC 60085 IEC 60038 IEC 60072 CEMER motors comply with the relevant European and International norms and regulations, in particular wi
The new IEC 61439 series is expected to have a similar structure to IEC 60439 with several new additions*: IEC 60439 IEC 61439 Series IEC 61439-1 General rules IEC 61439-2 Power switchgear and controlgear assemblies IEC 61439-6 Busbar trunking systems IEC 61439-3 Distribution boards IEC 61439-4 Assem
EMC: EN 55015 IEC 61000-3-3 IEC 61547 IEC 61000-4-2 IEC 61000-4-3 IEC 61000-4-6 IEC 61000-4-8 IEC 61000-4-11 Transient protection: 6kV/3kA combination wave, as per IEEE C62.41, line-line and line-ground IEC 61000-4-5 IEC 61000-4-4 THD: IEC 55015 20% @ 100-2
IEC 60634-1 IEC 60050-826 IEC 60364-4-41 IEC 60364-4-42 IEC 60364-5-52 IEC/DIS 64(CO)9173 IEC 60204-32 IEC 60529-1989; IEC 60529 IEC 60529 Accident prevention regulation "Electrical systems and apparatus" Accident prevention regulation "Cranes" Safety instructions "Monorails"
IEC 60060 / IEC 60071 High voltage test techniques./ Insulation coordination IEC 60099-4/ IEC 60859 Surge arresters/ Cable connections for GIS. IEC 60137 Bushings for alternating voltage above 1000V. IEC 60255/ IEC 60265 Electrical Relays./High voltage switches. IEC 60270 Partial discharge measurement. IEC 60376 / IEC 60480 Specification and .
Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. Crawford M., Marsh D. The driving force : food in human evolution and the future.
Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. 3 Crawford M., Marsh D. The driving force : food in human evolution and the future.
MARCH 1973/FIFTY CENTS o 1 u ar CC,, tonics INCLUDING Electronics World UNDERSTANDING NEW FM TUNER SPECS CRYSTALS FOR CB BUILD: 1;: .Á Low Cóst Digital Clock ','Thé Light.Probé *Stage Lighting for thé Amateur s. Po ROCK\ MUSIC AND NOISE POLLUTION HOW WE HEAR THE WAY WE DO TEST REPORTS: - Dynacó FM -51 . ti Whárfedale W60E Speaker System' .
Glossary of Social Security Terms (Vietnamese) Term. Thuật ngữ. Giải thích. Application for a Social Security Card. Đơn xin cấp Thẻ Social Security. Mẫu đơn quý vị cần điền để xin số Social Security hoặc thẻ thay thế. Baptismal Certificate. Giấy chứng nhận rửa tội
More than words-extreme You send me flying -amy winehouse Weather with you -crowded house Moving on and getting over- john mayer Something got me started . Uptown funk-bruno mars Here comes thé sun-the beatles The long And winding road .
Phần II: Văn học phục hưng- Văn học Tây Âu thế kỷ 14- 15-16 Chương I: Khái quát Thời đại phục hưng và phong trào văn hoá phục hưng Trong hai thế kỉ XV và XVI, châu Âu dấy lên cuộc vận động tư tưởng và văn hoá mới rấ