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YY 0286.1-2007Special infusion sets - Part 1: Infusion sets with precision filters for single use (English PDF)

专用输液器 第1部分:一次性使用精密过滤输液器

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

August 14, 2007

Implementation date

April 1, 2008

Scope

YY 0286.1-2007 is the English-translated version of 专用输液器 第1部分:一次性使用精密过滤输液器.

YY 0286.1-2007 is the Chinese standard "Special infusion sets - Part 1: Infusion sets with precision filters for single use". Its scope clause reads: This part of YY 0286 specifies the requirements for a single-use microfiltration filter infusion set (hereinafter referred to as an infusion set).

This section applies to a nominal aperture of 0.22µm1 ), an infusion set of a 1.2 µm, 2.0 µm to 5.0 µm medical solution filter. 1) Also marked as 0.2µm. Its clauses include terms and definitions; general requirements; tag example.

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Document preview — YY 0286.1-2007

National Standard of the People's Republic of China

Replacing
GB 18458.1-2001

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 General requirements
  • 5 tag example

1 Scope

This part of YY 0286 specifies the requirements for a single-use microfiltration filter infusion set (hereinafter referred to as an infusion set).

This section applies to a nominal aperture of 0.22µm1

), an infusion set of a 1.2 µm, 2.0 µm to 5.0 µm medical solution filter.

1) Also marked as 0.2µm.

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 8368 Disposable Infusion Set Gravity Infusion

YY/T 0918 liquid filtration membrane, liquid filtration filter method for bacterial retention

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Microporous filtration infusion set

An infusion set with a medical fluid filter having a nominal pore size of 0.22 µm, 1.2 µm, and 2.0 µm to 5.0 µm.

3.2 Sterilization-grade liquid filter

A liquid filter with a nominal pore size of no more than 0.22 µm.

3.3 Micron grade filter

A chemical liquid filter having a nominal pore size of 1.2 µm and 2.0 µm to 5.0 µm.

4 General requirements

With the general requirements of GB 8368 (except for the pore size of the liquid filter).

5 tag example

5.1 Infusion set

The infusion set that meets the requirements of this part of YY 0286 and has a nominal liquid crystal filter with a pore size of 0.22 µm shall be described in the text of the text.

The number, the letter IS, plus the letter F and the filter nominal aperture mark are as follows.

Infusion set YY 0286.1-IS-F0.22

YY/T 0285.6-2020 | YY/T 0286.4-2020 | YY 0285.5-2018 | YY/T 0294.1-2024 | YY/T 0282-2024 | YY/T 0286.5-2021 | […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of YY 0286.1

EditionTitleRevisionStatus
YY 0286.1-2007Special infusion sets - Part 1: Infusion sets with precision filters for single usecurrent editionCurrent
GB 18458.1-2001Special infusion sets - Part 1: Infusion sets with precision filters for single useprevious editionSuperseded

This page sells the current edition, YY 0286.1-2007. Earlier editions are listed for reference only.

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YY 0286.1-2007

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