YY 0286.1-2019Infusion sets for special purpose - Part 1: Infusion sets for single use with micropore filters (English PDF)

Foreword

YY 0286 "Special Infusion Set" consists of the following parts.

--- Part 1. Single-use microfiltration filtration infusion set;

--- Part 2. Single-use burette infusion set, gravity infusion;

--- Part 3. One-time use of light infusion sets;

--- Part 4. Infusion sets for single use pressure infusion equipment;

---Part 5. Disposable bottle and bag infusion sets;

--- Part 6. Single-use flow setting fine-tuning infusion set. This part is the first part of YY 0286.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This section replaces YY 0286.1-2007. Compared with YY 0286.1-2007, the main technical changes except editorial changes are as follows.

---The standard name was changed from the "precision infusion set" to the current name, and the scope was expanded to the sterilization level;

--- Increased the requirements for the sterilization grade liquid filter;

--- Increased the requirement of a liquid filter with a nominal pore size of 1.2 µm;

--- Increased venting requirements.

Introduction

With the continuous development of infusion technology and the increasing clinical requirements, there have been some infusions that can be adapted to special clinical requirements.

Device. It is not expected to include all infusion sets with special requirements in one standard. Therefore, the various parts of YY 0286 These dedicated infusion sets are only specified for a specific clinical requirement. Some special infusion sets may belong to a variety of special infusion sets, should At the same time, the part corresponding to YY 0286 is executed.

The difference between the micro-filtered infusion set specified in this section of YY 0286 and the ordinary infusion set is that the former has a higher filtration performance.

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 document. 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.

4 General requirements

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

5 Tag example