YY 0465-2003Single-use hollow fiber plasma separators (English PDF)

1 Scope

This standard specifies the terms and definitions, type and model nomenclature for single-use hollow fiber plasma separators and plasma component separators.

Requirements, test methods, inspection rules, marking and packaging, transportation, storage.

This standard applies to single-use hollow fiber plasma separators and plasma component separators. Single-use hollow fiber plasma separation

The device (referred to as a plasma separator) is combined with a plasma separation device to treat various immune, metabolic disorders and certain poisoning diseases. One-time

Hollow fiber plasma component separator (referred to as plasma component separator) is suitable for performing double filtration plasma exchange therapy with plasma separator

In combination, a certain molecular weight substance is separated from the separated plasma by a membrane separation method.

2 Normative references

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

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

GB/T 191 packaging storage and transportation icon

GB/T 1962.2 syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints

GB/T 13074 blood purification terminology

GB/T 14233.1-2008 Methods of test for infusions, blood trans

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management

GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood

GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test

GB/T 16886.10 Biological evaluation of medical devices - Part 10. Stimulation and skin sensitization test

GB/T 16886.11 Biological evaluation of medical devices - Part 11. Systemic toxicity test

YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements

Pharmacopoeia of the People's Republic of China (2015 Edition)

3 Terms and definitions

The following terms and definitions as defined in GB/T 13074 apply to this document.