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EN/IEC 60601-1. EN/IEC 60601-2. 73/23/EEC. våtservetter under varje pass, varje dag.2 IEC 60601-1-2: 2015-certifiering innebär att den kan användas i patientsalar och sjuksköterskereceptioner.3. Förenkla Den bästa lösningen för sammanlagda ägandekostnader. • Utrustad för Windows Vista. • EN/IEC 60601-1-certifierad för medicinska miljöer.

IEC 60601 is a series of technical standards applies to Medical Electrical Equipment & Medical Electrical System for Basic Safety & Essential Performance. Clause 12.2 Usability, referencing IEC 60601-1-6 Clause 17 EMC, referencing IEC 60601-1-2 TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch /5F, Communication Building, 163 Pingyun Rd, Huangpu West Ave. Guangzhou 510656 P. R. China Summary of compliance with National Differences List of countries addressed: 2020-11-10 Within IEC 60601-1, there are “collateral” standards that are denoted as IEC 60601-1-x; for example, IEC 60601-1-2 is the EMC collateral standard mentioned above. Other collateral standards include 60601-1-3, covering radiation protection for diagnostic x-ray systems, 60601-1-9 relating to environmental design, and 60601-1-11 recently introduced for home healthcare equipment. patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 60601-1-2 has been prepared by sub-committee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee … The IEC 60601-1 obligates manufacturers of medical electrical equipment and systems to ensure that they are completely fail-safe in their use and work reliably at all times.

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.

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IEC 61000-4-2. ±6 kV ledningsburen.

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While 60601-1 is the basic general standard, particular standards branch off into specific devices, such as high frequency surgical, endoscopic equipment, and infant incubators.

Svensk beteckning: SS-EN 60601-1, utg 2:2006. CENELEC Publikation: EN 60601-1:2006. IEC Publikation: IEC 60601-1:2005. Fastställelsedatum: 2006-11-19. IEC TC 62 - Electrical equipment in medical practice. Status: Publicerad. Beteckning: IEC 60601-1:2005.
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60601. The IEC 60601 was first published in 1977, then referred to as IEC 601, and handles the electrical safety of both mechanical and electrical issues. It is constructed from 2 parts; IEC 60601-1 and IEC 60601-2, each built-up from a number of basic or collateral standards. Collateral standard IEC 60601-1-x (x representing a collateral IEC 60601-1 does not apply to medical gas pipeline systems covered by ISO 7396-1, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum.

It is equivalent to the international standard IEC 60601 and comprises over 70 individual standards. IEC 60601-1 är en standard från International Electrotechnical Commission (IEC) specifik för elektriska medicintekniska produkter .
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P 4.3 Performance of clinical functions necessary to achieve iNTENDED USEor that could affect the safety of the ME EQUIPMENTor ME SYSTEMwere identified during RISK ANALYSIS. Not define essential performance N/A - Performance limits were identified in both The Evaluation Package is a summary of the IEC 60601-1:2012 standard, other applicable requirements, guidance information, and interpretations, to help evaluate medical electrical equipment to the requirements of the Standard. It is being provided FREE of charge, to help people understand and meet the requirements for medical devices. IEC 60601-1 is intended to serve as a tool in the risk management process. To that end, clause 4.2 specifies: A risk management process according to ISO 14971 shall be performed.