C39 医用电子仪器设备 标准查询与下载



共找到 712 条与 医用电子仪器设备 相关的标准,共 48

Graphical symbols for electrical equipment in medical practice

ICS
01.080.20;11.040.60
CCS
C39
发布
2015-10-31
实施
2015-10-31

Medical electrical equipment -- Part 2-205: Particular requirements for the basic safety and essential performance of medical practice massager

ICS
11.040.60;97.170
CCS
C39
发布
2015-10-01
实施

Medical electrical equipment -- Part 2-204: Particular requirements for the basic safety and essential performance of pneumatic compression equipment

ICS
11.040.60
CCS
C39
发布
2015-10-01
实施

Medical electrical equipment -- Part 2-201: Particular requirements for the basic safety and essential performance of hydrotherapy and warmbaththerapy equipment

ICS
11.040.60
CCS
C39
发布
2015-10-01
实施

Medical electrical equipment -- Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

ICS
11.140
CCS
C39
发布
2015-10-01
实施

Medical electrical equipment -- Part 2-207: Particular requirements for the basic safety and essential performance of xenon ray beam therapy equipment

ICS
11.040.60
CCS
C39
发布
2015-10-01
实施

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2014); German version EN 62353:2014

ICS
11.040.01
CCS
C39
发布
2015-10
实施

Medical electrical equipment - Part 2-26 : particular requirements for the basic safety and essential performance of electroencephalographs

ICS
11.040.55
CCS
C39
发布
2015-09-12
实施
2015-09-12

Dieser Teil von ISO 80601 gilt für die Basissicherheit und die wesentlichen Leistungsmerkmale eines Beatmungsgeräts in Kombination mit dessen Zubehör, nachfolgend als ME-Gerät bezeichnet, das: für die Anwendung in der medizinischen Versorgung in häuslicher Umgebung vorgesehen ist; für die Anwendung durch einen nicht fachkundigen Bediener vorgesehen ist; für Patienten vorgesehen ist, die für die Erhaltung ihres Lebens von mechanischer Beatmung abhängig sind. Anmerkung 1: Derartige Beatmungsgeräte können auch bei Patienten angewendet werden, die nicht von einer Atemunterstützung abhängig sind. Anmerkung 2: Bei der medizinischen Versorgung IN häuslicher Umgebung ist die Antriebsenergie für das Beatmungsgerät häufig nicht zuverlässig. Anmerkung 3: Derartige Beatmungsgeräte können auch bei nichtkritischen Pflegeanwendungen in professionellen Einrichtungen des Gesundheitswesens eingesetzt werden. - Dieser Teil von ISO 80601 gilt auch für Zubehör, das durch den Hersteller des Zubehörs für den Anschluss an ein Atemsystem des Beatmungsgeräts oder an ein Beatmungsgerät vorgesehen ist, sofern die Merkmale dieses Zubehörs die Basissicherheit oder die wesentlichen Leistungsmerkmale des Beatmungsgeräts beeinflussen können. Beispiele: Atemschläuche, Verbindungsstücke, Wasserfallen, Exspirationsventile, Anfeuchter, Atemsystemfilter, externe Stromversorgung und verteiltes Alarmsystem.

Medical electrical equipment Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

ICS
11.040.10
CCS
C39
发布
2015-09-01
实施

This technical report provides a comprehensive compilation, for easy reference, of graphical symbols (graphics, title, description) and safety signs for medical electrical equipment. The graphical symbols are grouped in sections according to their specific field of application (see Clause 3).

Graphical symbols for electrical equipment in medical practice

ICS
01.080.10;11.040.01;11.040.60
CCS
C39
发布
2015-09
实施

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (IEC 60601-2-22:2007 + A1:2012); German version EN 60601-2-22:2013

ICS
11.040.55;11.040.60
CCS
C39
发布
2015-08
实施

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems (IEC 60601-2-66:2012); German version EN 60601-2-66:2013

ICS
11.180.15
CCS
C39
发布
2015-08
实施

Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

ICS
11.040.20
CCS
C39
发布
2015-07-31
实施
2015-07-31

Scope and object Equipment included in scope Replacement: This International Standard specifies safety requirements for electrical equipment intended for sterilization@ washing@ and disinfection of medical materials in the medical@ veterinary@ pharmaceutical and laboratory fields@ when used under the environmental conditions of 1.4. Examples of such equipment are: a) STERILIZERS and disinfectors using steam; b) STERILIZERS and disinfectors using toxic gas@ toxic aerosol or toxic vapour; c) STERILIZERS and disinfectors using hot air or hot inert gas@ and d) washer disinfectors. Equipment excluded from scope Add the following note to item g) NOTE IEC 60601-1(definition 2.2.15 modified) defines medical electrical equipment as follows: Electrical equipment@ provided with not more than one connection to a particular supply MAINS and intended by its manufacturer to be used in the diagnosis@ treatment@ or monitoring of a patient; and that makes physical or electrical contact with the patient or transfers energy to or from the patient or detects such energy transfer to or from the patient. Add the following new second paragraph: This standard also does not apply to the following types of equipment: aa) equipment for use in hazardous gas atmospheres (see IEC 60079) except for an atmosphere created inside equipment by the use of a flammable sterilizing agent (see 13.0); bb) environmental cabinets (see IEC 61010-1); cc) laboratory equipment for the heating of materials for other purposes than sterilization or disinfection (see IEC 61010-2-010); dd) laundry equipment (see IEC 60335@ Parts 2-4@ 2-7@ and 2-11@ and ISO 10472)@ unless designed for disinfecting medical materials; ee) dishwashers (see IEC 60335@ Parts 2-5 and 2-58). Aspects included in scope Replacement: Replace item g) and the note by the following new text and note: g) liberated gases (including the non-intentional escape of toxic gas)@ pathogenic substances@ explosion and implosion (see Clause 13). NOTE Attention is drawn to the existence of additional requirements which may be specified by national authorities responsible for the health and safety of labour forces. In particular@ national and other regulations or codes apply for the safety of automatic loading and unloading systems. Aspects excluded from scope Add the following two new items: aa) special requirements for protection against chemical and high-risk micro-biological HAZARDS associated with the LOAD; bb) general requirements for the design of calorifiers@ shell boilers and PRESSURE VESSELS. NOTE National and other regulations or codes apply for the safety of calorifiers@ shell boilers and PRESSURE VESSELS.

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

ICS
11.080.10;19.080;71.040.10
CCS
C39
发布
2015-07
实施
2015-07-09

Medical electrical equipment. Particular requirements for the basic safety and essential performance of short-wave therapy equipment

ICS
11.040.60
CCS
C39
发布
2015-06-30
实施
2015-06-30

Medical electrical equipment. Particular requirements for the basic safety and essential performance of microwave therapy equipment

ICS
11.040.60
CCS
C39
发布
2015-06-30
实施
2015-06-30

Medical electrical equipment. Particular requirements for the basic safety and essential performance of infusion pumps and controllers

ICS
11.040.20
CCS
C39
发布
2015-06-30
实施
2015-06-30

Medical electrical equipment. Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

ICS
11.040.50
CCS
C39
发布
2015-06-30
实施
2015-06-30

Medical electrical equipment. Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

ICS
11.040.10
CCS
C39
发布
2015-06-30
实施
2015-06-30

Medical electrical equipment. Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

ICS
11.040.55
CCS
C39
发布
2015-06-30
实施
2015-06-30



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