Iec 606011 medical design standards for power supplies. Ul standards testing and certification process in more detail with you to meet your specific needs and requirements. The interpretation sheet is available from document center inc. Approved for standalone use in all patientcare vicinities.
This second edition of 6060111 cancels and replaces the first edition published in 1992 and its amendment 11995 and constitutes a technical revision. Easy the easy grips disposable bag valve mask resuscitator is a single use device for manual ventilation. This international standard deals with the safety of electrical appliances for household and similar purposes, their rated voltage being not more than 250 v for singlephase appliances and 480 v for other appliances. General requirements for safety includes all amendments and changes through revision pages, april 26, 2006. Primarily the performance and construction provisions found in the ul 606011 or related standard. Ul 606011 or ul 63a compliance, including medical, diagnosticimaging, pharmaceutical, lab and ems equipment, mobile cart and telemedical equipment, computerinformation systems equipment and telecomsecurity equipment. The object of this standard is to specify general requirements for the safety of medical electrical equipment and to serve as the basis for the safety requirements of particular standards.
When a device is ullisted, this means that ul has tested the device, and it meets their requirements for safety i. Understanding iec 60601 1 is crucial to electrical safety and regulatory compliance. Designing for compliance to iec 606011, 2nd edition and transition to the 3rd edition bundled workshop description. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Ul experts will discuss the standard and its effect on your operation.
General requirements for safety, hereinafter referred to as the general standard. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. Designing for compliance to iec 606011, 2nd edition and. In the united states, for example, the local version of iec 606011 is the ansiul 26011 standard. General requirements for basic safety and essential performance, clause 14 programmable electrical medical systems pems. In general ul will only accept components which have been approved by ul itself, though other nrtls national. Missing page numbers correspond to the frenchlanguage pages. This ul white paper provides an overview of the new and modified requirements presented in iec 60601 1 edition 3. The new philosophy of the 3rd edition september 2010 intertek 70 codman hill road. Power strips and power strips with hospital grade receptacles. All interim revisions for this edition available at time of your purchase will be included.
Tripp lite offers the broadest range of medicalgrade power protection and power supply solutions available. Iec 606011 medical electrical equipment part 1 tdklambda emea. It is available at the 2nd edition of iec 606011 may also be applied. Ul healthcare and life sciences supports medical device manufacturers industry demands for risk management and facility, device. All nonmedical equipment and personal devices are required to be plugged directly into the wall within the patientcare vicinity. General requirements for safety, hereinafter referred to as the general standard, and. Iec 606011 medical design standards for power supplies cui inc. Ul 606011 usa medical device design for iec 606011. Back to standard 606011, edition 1 the cost to purchase this standard varies depending on whether you are ordering a hardcopy, pdf or combination of the two. Our breadth, established objectivity and proven history mean we are a symbol of trust, enabling us to help provide peace of mind to all. It constitutes a collateral standard to iec 606011.
Close field proximity 15 specific test frequencies 9 vm to 28 vm mostly pulse modulations future communication services should be considered. Other collateral standards include 60601, covering radiation protection for diagnostic xray systems, 6060119 relating to environmental design, and 60601111 recently introduced for home healthcare equipment. Ul certification customers have free access to ul standards, not including ul iec based standards. Complete document ul standard for safety medical electrical equipment, part 1. A particular standard takes priority over this general standard. Medical grade strips are designed to be used within and outside patient care areas, including the patient care vicinity. It has been adopted without any technical modifications with a. General requirements for basic safety and essential performance. For patient care vicinity ul 60601 1 medical grade power. Usability issued by the international electro technical commission iec. The sutures are colored violet to increase visibility and are also available undyed.
Given the size of the original standard and the complexity of the changes, implementing the changes can seem overwhelming. This standard applies to the safety of medical electrical equipment as defined in subclause 2. Iec 60601 is a series of technical standards for the safety and essential performance of. Although this standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety. Statement regarding use of iec 606011 medical electrical. Top 5 faqs when choosing healthcare power products. General requirements for basic safety and essential performance, has just had interpretation sheet 3 released. Sept iec 606011 checklist checklistfor standard iec 606011 ed. For patientcare vicinity ul 606011 medicalgrade power strip with surge protection and 4 hospital grade outlets, 1410 joules model number. Changes from 2nd to 3rd edition 8 while the 3rd edition of iec 606011 now includes ep requirements, the manufacturers ep requirements may vary from the standards, depending on the proposed use of the device. The medical device industry is the most heavily regulated in manufacturing, for good reason. The iec 606011 is the general overview document for the iec 60601 series. Devices that do not meet the highest quality and safety standards present a risk of injury, recalls, embargos, bans and liability.
Sps415hgultra description the sps415hgultra is the first medicalgrade outlet strip with surge suppression and full ul 606011609501 compliance. Certain components must comply with the relevant ansiul standards for those components, e. Full 606011 compliance and agency listing, surge protection, integrated locking safety covers and a 15 ft. Healthcaremedical solutions for patient care vicinities. International standard iec 6060116 2010 medical electrical equipment part 16. We also offer two different types of subscriptions. Designing for compliance to iec 606011 3rd edition. As shown in the diagram below, when corrigendum 1 and 2, and amendment 1 are applied to edition 3, the resulting document is the same as edition 3.
First published in 1977 and regularly updated and restructured, as of 2011 it consists of a general standard, about 10 collateral standards, and about 80 particular standards. International standard iec 6060114 has been prepared by iec technical committee 62. Ul 603351 safety of household and similar appliances. The advanced extrusion process of the molecule of lactomer 91, the exclusive braiding process and coating system, give the suture. Iec 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the international electrotechnical commission. They are prepared by coating the suture with a mixture of a caprolactoneglycolide copolymer and calcium stearoyl lactylate. Full 606011 compliance and agency listing, surge protection, integrated locking safety covers and a 6 ft. Only medical and diagnostic equipment is to be plugged into a ul 606011 compliant power strip or surge protector within the patientcare vicinity. Covidien suture, ul101, 60, polysorb undyed 18 cvf21. Here are some of the standards that f2 labs can evaluate your product to. For patientcare vicinity ul 606011 medicalgrade power. The major thrust of the 606011 standard is to require two levels of protection to shield operators and patients from getting hurt. There is often confusion regarding the differences between iec 606011 ed 3, and iec 606011 ed 3.
The slower nature of the publication and adoption of the revised standard also led way to amendment 1, which mainly clarifies the original intent of edition 3. In the last 20 years, the ul safety standard for medical beds has evolved from ul544 to ul2601 to ul60601. This bundled threeday course will help you gain a thorough understanding of how to use iec 606011 and ul 606011 effectively along with the changes that will be brought about by the issuance of iec 606011, 3rd edition. General requirements for basic safety and essential performance collateral standard.
Iec 606011 is a lengthy, complex electrical safety standard. Lithium batteries must comply with ul 1642, fuseholders with ul 512, etc. Iec 606011 is intended to serve as a tool in the risk management process. The standard introduces electromagnetic em environments of intended use, including professional healthcare facilities and home healthcare. This second edition is a collateral standard to iec 606011. The primary standard governing medical device design is formally known as iec 606011.
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