IEC 60601-2-1. EN 60601-2-1. Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

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Aug 24, 2020 The fourth edition IEC/EN 60601-1-2 (4th Edition) will become a pumps have their own product-specific basic standard: IEC/EN 60601-2-24.

Edition 3.0 2009-10. INTERNATIONAL. STANDARD. NORME. INTERNATIONALE.

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The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 80601-2-59:2017 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME equipment. IEC 60601-2-22:2019 is available as IEC 60601-2-22:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-2-22:2019 applies to the Basic Safety and Essential Performance of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for IEC 60601-2-21:2020 is available as IEC 60601-2-21:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-2-21:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT. IEC 60601-2-13:2003 Medical electrical equipment — Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems. This standard has been revised by ISO 80601-2 … IEC 60601-2-35:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT.

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The quality system has been examined by RISE Research. Institutes of Sweden AB, notified body No: 0402. Vansbro 2017-10-04  Obs 1: Tabellen innehåller olika testvärden från standarden IEC 60601-2-24. För dessa testvärden tillåts inga farliga störningar, medan störningar tillåts för de  parater än mammografiapparater (IEC 60601-1-3:2008).

IEC 60601-2-20:2020 is available as IEC 60601-2-20:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-2-20:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.208, also referred to as ME EQUIPMENT.

Kranvatten  Kravspecifikation B, position B2. Standard IEC 60601-2-52 är en standard för elektriskt reglerbara vård/sjukhus-sängar. Vi undrar om det är tillämpligt att kräva  Elektrisk utrustning för medicinskt bruk – Säkerhet – Del 2-2: Särskilda fordringar på kirurgiska diatermiapparater och tillbehör (IEC 60601–2–2:2009). IEC 60601-2-52:2010. □ IEC 980:2008.

Iec 60601-2

This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). International standard IEC 60601-2-52 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice, and by ISO technical committee 173: Assistive products for persons with disability. IEC 60601-2-19:2020 is available as IEC 60601-2-19:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-2-19:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209, also referred to as ME EQUIPMENT. IEC 60601-2-20:2020 is available as IEC 60601-2-20:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-2-20:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.208, also referred to as ME EQUIPMENT. IEC 60601-2-19:2020 RLV contains both the official IEC International Standard and its Redline version.
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In contrast, regulation supports the evaluation each component of a system as a seperate medical device. IEC 60601-2-39:2019 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a IEC 60601-2-57 Medicinsk elektrisk utrustning - Del 2-57: Särskilda krav för grundläggande säkerhet och väsentlig prestanda för icke-laserljuskällutrustning avsedd för terapeutisk, diagnostisk, övervakning och kosmetisk / estetisk användning IEC 60601-2-2 의료용 전기 기기 - 파트 2-2 : 고주파 수술 장비 및 고주파 외과 용 액세서리의 기본 안전 및 필수 성능을 위한 특정 요구 사항. IEC 60601-2-3 의료용 전기 기기 - 파트 2-3 : 단파 치료기의 기본 안전 및 필수 성능을 위한 특정 요구 사항.

If the UV radiation exceeds certain emission threshold values, for example, for risk group 3, additional design measures such as emergency stop and key switches will be necessary.
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IEC 60601-2-1 Scope: IEC 60601 2 1 and EN 60601 2 1 testing applies to the basic safety and essential performance of electron accelerators, hereafter referred to as medical electronic equipment, in the range 1 MeV to 50 MeV, used for treatment of patients.

EKG visar t.ex. puls, hjärtrytm och elektriska aktiviteter och hjärtats båda kammare. TMC enkanals EKG stödjer EC 60601-1-1 och IEC 60601-2-27 standarder.


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IEC 60601-2-54:2009 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy.

Status: Publicerad. Beteckning: IEC 60601-2-43:2010. Fastställelsedatum: 1969-12-31.