YY 1413-2016Centrifugal blood component separation device (English PDF)

1 Scope

This standard specifies the terms and definitions of centrifugal blood component separation equipment (hereinafter referred to as equipment), requirements, test methods, signs, use

Brochures and packaging, transportation, storage.

This standard applies to the use of disposable supplies to connect blood donors, can simultaneously achieve blood collection, centrifugal blood composition separation,

Return equipment.

This standard does not apply to the following products.

- equipment or consumables for non-centrifugal blood separation, such as extrusion or membrane separation (eg separation or adsorption, etc.)

Or supplies;

--- with the equipment used in the pipeline, centrifugal cup, centrifugal bags and other supplies annex;

--- autologous blood recovery equipment;

--- Medical centrifuge;

--- only the blood of the blood bag to deal with the 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 icon

Medical electrical equipment - Part 1. General requirements for safety GB 9706.1

General specification for industrial product brochures GB/T 9969-2008

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

GB 18469 Whole blood and ingredients Blood quality requirements

YY/T 0466.1 Symbols for use in medical device labeling and information for medical devices - Part 1. General requirements

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

Test and guidance for alarm systems in electrical systems

3 terms and definitions

GB 18469 and GB 9706.1 and the following terms and definitions apply to this document.