E DIN EN IEC 60601-2-16 VDE 0750-2-16:2022-10

Medical electrical equipment

Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

(IEC 62D/1912/CD:2021); Text in German and English
Class/Status: Draft, valid
Released: 2022 -10 Published: 2022-09 -30
VDE Art. No.: 1701774
End of objection deadline: 2022-11-30

This part of IEC 60601 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment, hereafter referred to as haemodialysis equipment. It applies to haemodialysis equipment intended for use either by medical staff or under the supervision of medical experts, including haemodialysis equipment operated by the PATIENT, regardless of whether the haemodialysis equipment is used in a hospital or domestic environment.

This Document is related to the following Topics (in bold):

11	HEALTH CARE TECHNOLOGY
11.020	Medical sciences and health care facilities in general
11.040	Medical equipment
11.060	Dentistry
11.080	Sterilization and disinfection
11.100	Laboratory medicine
11.140	Hospital equipment
11.180	Aids for disabled or handicapped persons

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Title		Format
	Prinz, Thorsten (Hrsg.) Entwicklung und Herstellung medizinischer Software Normen in der Medizintechnik VDE-Schriftenreihe – Normen verständlich, Band 171 2017, 219 pages, Din A5, Broschur Dieser Buchtitel ist auch als E-Book (PDF) erhältlich