Medical electrical equipment - Part 1-6: General requirements for safety

IEC 60601-1-6*CEI 60601-1-6

Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability

Số trang: 156
Ngày phát hành: 2004-06-00

Liên hệ

Tóm tắt
Chi tiết

Medical practice is increasingly using medical electrical equipment for observation and treatment of patients. use errors caused by inadequate medical electrical equipment usability have become an increasing cause for concern. The usability engineering process is intended to achieve reasonable usability, which in turn is intended to minimise use errors and to minimise use associated risks. Some, but not all, forms of incorrect use are amenable to control by the manufacturer. The usability engineering process is part of the process of risk control. This Collateral Standard describes a usability engineering process, and provides guidance on how to implement and execute the process to provide medical electrical equipment safety. It addresses normal use and use errors but excludes abnormal use.

Số hiệu tiêu chuẩn

IEC 60601-1-6*CEI 60601-1-6

Tên tiêu chuẩn

Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability

Ngày phát hành

2004-06-00

Trạng thái

Hết hiệu lực

Tiêu chuẩn tương đương

DIN EN 60601-1-6 (2005-06), IDT * BS EN 60601-1-6 (2004-11-17), IDT * EN 60601-1-6 (2004-11), IDT * NF C74-016 (2005-04-01), IDT * CAN/CSA-C22.2 No. 60601-1-6-05 (2005-11-01), IDT * OEVE/OENORM EN 60601-1-6 (2005-08-01), IDT * PN-EN 60601-1-6 (2005-05-15), IDT * SS-EN 60601-1-6 (2004-12-20), IDT * UNE-EN 60601-1-6 (2005-07-06), IDT * GOST IEC 60601-1-6 (2011), IDT * GOST R IEC 60601-1-6 (2007), IDT * STN EN 60601-1-6 (2005-06-01), IDT * STN EN 60601-1-6 (2007-06-01), IDT * CSN EN 60601-1-6 (2005-06-01), IDT * NEN-EN-IEC 60601-1-6:2004 en;fr (2004-11-01), IDT

Tiêu chuẩn liên quan

IEC 60601-1*CEI 60601-1 (1988) * IEC 60601-1 AMD 1*CEI 60601-1 AMD 1 (1991-11) * IEC 60601-1 AMD 2*CEI 60601-1 AMD 2 (1995-03) * IEC 60601-1-8 (2003-08) * ISO 14971 (2000-12) * ISO 14971 AMD 1 (2003-03)

Thay thế cho

IEC 62A/452/FDIS (2004-03)

Thay thế bằng

IEC 60601-1-6*CEI 60601-1-6 (2006-12)

Lịch sử ban hành

IEC 60601-1-6*CEI 60601-1-6 (2010-01) * IEC 60601-1-6*CEI 60601-1-6 (2006-12) * IEC 60601-1-6*CEI 60601-1-6 (2004-06) * IEC 62A/452/FDIS (2004-03) * IEC 62A/422/CDV (2003-03)

Từ khóa

Accident prevention * Anaesthesiology * Ball compression test * Classes of protection * Classification * Classification systems * Clearances * Colour codes * Definitions * Design * Determinations * Dimensions * Earth conductors * Earthing * Electric appliances * Electric contact protection * Electric enclosures * Electric mains * Electric power systems * Electric shocks * Electrical accidents * Electrical engineering * Electrical equipment * Electrical medical equipment * Electrical protection equipment * Electrical safety * Electrically-operated devices * Electromagnetic compatibility * Electromedicine * Electrostatics * EMC * Enclosures * Environmental conditions * Equipment * Equipment safety * Explosion protection * Fire safety * Fitness for purpose * Graphic symbols * Hazards * Hot-mandrel * Impact testers * Inspection * Instructions for use * Insulating enclosures * Insulating materials * Insulations * Leakage paths * Letterings * Lists * Marking * Measurement * Mechanical safety * Medical equipment * Medical radiology * Medical sciences * Medical technology * Occupational safety * Operational instructions * Protection against electric shocks * Protection coverings * Qualification tests * Radiation protection * Risk analysis * Safety * Safety devices * Safety engineering * Safety regulations * Safety requirements * Specification (approval) * Strength of materials * Surveys * Symbols * Temperature * Test atmospheres * Test equipment * Testing * Testing conditions * Testing voltages * Transformers * Dictionaries * Directories * Registers

Mục phân loại

11.040.01. Thiết bị y tế nói chung

Số trang

156

Medical electrical equipment; part 1: general requirements for safety
Số hiệu tiêu chuẩn	IEC 60601-1*CEI 60601-1
Ngày phát hành	1988-00-00
Mục phân loại	11.040.01. Thiết bị y tế nói chung
Trạng thái	Có hiệu lực

Medical electrical equipment; part 1: general requirements for safety; amendment 1
Số hiệu tiêu chuẩn	IEC 60601-1 AMD 1*CEI 60601-1 AMD 1
Ngày phát hành	1991-11-00
Mục phân loại	11.040.01. Thiết bị y tế nói chung
Trạng thái	Có hiệu lực

Medical electrical equipment - Part 1: General requirements for safety; Amendment 2
Số hiệu tiêu chuẩn	IEC 60601-1 AMD 2*CEI 60601-1 AMD 2
Ngày phát hành	1995-03-00
Mục phân loại	11.040.01. Thiết bị y tế nói chung
Trạng thái	Có hiệu lực

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
Số hiệu tiêu chuẩn	IEC 60601-1-6*CEI 60601-1-6
Ngày phát hành	2006-12-00
Mục phân loại	11.040.01. Thiết bị y tế nói chung
Trạng thái	Có hiệu lực

Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability
Số hiệu tiêu chuẩn	IEC 60601-1-6*CEI 60601-1-6
Ngày phát hành	2010-01-00
Mục phân loại	11.040.01. Thiết bị y tế nói chung
Trạng thái	Có hiệu lực

IEC 60601-1-6*CEI 60601-1-6

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