YY 1493-2016Gravity control peritoneal dialysis equipment (English PDF)

1 Scope

This standard specifies the terminology and definitions, requirements, test methods, logos, instructions and packaging for gravity-controlled peritoneal dialysis equipment,

Transport, storage.

This standard applies to gravity-controlled peritoneal dialysis equipment (hereinafter referred to as equipment).

This standard does not apply to.

Peritoneal dialysis in the process of disposable materials (such as dialysis solution, dialysis fluid line);

--- Pressure-controlled peritoneal dialysis equipment.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article

Pieces. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 191 Packaging and Storage Icons (GB/T 191-2008, ISO 780..1997, MOD)

GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988, IDT)

GB 9706.39 Medical electrical equipment - Part 2-39. Particular requirements for the safety of peritoneal dialysis equipment (GB 9706.39-2008,

IEC 60601-2-29..2003, IDT)

General rules for the use of industrial products GB/T 9969

Glacier for blood purification GB/T 13074

Environmental requirements and test methods for medical appliances GB/T 14710-2009

YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements (YY/T 0466.1-2009, ISO 15223-1..2007, IDT)

YY 0709 Medical electrical equipment - Part 1-8. Safety requirements for general requirements. General requirements, medical electrical equipment and medical use

Test and guidance for alarm systems in electrical systems (YY 0709-2009, IEC 60601-1-8..2003, IDT)

3 terms and definitions

GB 9706.39 and GB/T 13074 and the following terms and definitions apply to this document.