YY 0321.3-2009 English PDF (YY0321.3-2009)

This Standard specifies the requirements for single-use filter for anaesthesia. This Part is applicable to single-use filter for anaesthesia that is used together with single-use puncture needle for anesthesia.

YY 0321.3-2009
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0321.3-2000
Single-use filter for anaesthesia
ISSUED ON. JUNE 16, 2009
IMPLEMENTED ON. DECEMBER 1, 2010
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Classification and marks... 6
4 Materials ... 7
5 Physical requirements ... 7
6 Chemical requirements ... 8
7 Biological requirements ... 9
8 Marks ... 9
Annex A (Normative) Physical test ... 11
Annex B (Normative) Type inspection rules ... 14
Foreword
YY 0321 consists of the following parts.
- Single-use puncture set local anaesthesia;
- Single-use needle for anaesthesia;
- Single-use filter for anaesthesia.
This Part is the 3rd part of YY 0321.
This Part replaces YY 0321.3-2000 Single-use filter for anaesthesia.
Compared with YY 0321.3-2000, the main technical modifications in this Part are as follows.
- added requirements for filter media pore size of liquid filter (5.3.1 of this Part);
- modified test method for filtration efficiency of liquid filter (4.2.2.1 and Annex A of YY 0321-2000; 5.3.1 and A.1 of this Part);
- modified liquid flow indicator and test method for liquid filter (4.2.4 and Annex C of YY 0321-2000; 5.6 of this Part);
- modified test method for particle contamination of liquid filter (Annex B of YY 0321-2000; A.4 of this Part);
- deleted biological evaluation requirements for air filter (Clause 7 of this Part);
- modified inspection rules (Clause 6 of YY 0321-2000; Annex B of this
Part).
Annex A, Annex B of this Part are normative.
This Part was proposed by National Food and Drug Administration.
This Part shall be under the jurisdiction of National Medical Syringe (Needle) Standardization Technical Committee.
Main drafting organization of this Part. Wuhan Zhixun Chuangyuan
Technology Development Co., Ltd.
The drafting organizations of this Part. Beijing Volt Technology Co., Ltd., Zhejiang Volte Medical Equipment Co., Ltd.
Single-use filter for anaesthesia
1 Scope
This Standard specifies the requirements for single-use filter for anaesthesia. This Part is applicable to single-use filter for anaesthesia (hereinafter referred to as filter) that is used together with single-use puncture needle for anesthesia.
2 Normative references
The provisions in following documents become the provisions of this
Standard through reference in this Standard. For dated references, the
subsequent amendments (excluding corrigendum) or revisions do not apply to this Standard, however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies.
GB/T 1962.1, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1. General requirement
GB/T 1962.2, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2. Lock fittings
GB 8368, Infusion sets for single use -- gravity feed
GB/T 14233.1, Test methods for infusion transfusion injection equipment for medical use - Part 1. Chemical analysis methods
GB/T 14233.2, Test methods for infusion, transfusion, injection equipment for medical use - Part 2. Biological test methods
GB 15810, Sterile hypodermic syringes for single use
GB/T 16886.1, Biological evaluation of medical devices - Part 1. Evaluation and testing within a risk management process
YY 0466, Medical devices -- Symbols to be used with medical device
labels labelling and information to be supplied
3 - filter membrane;
4 - base (outer 6.100 taper);
5 - outer cone joint protective case.
Figure 2 -- Liquid filter typical structure
NOTE 1 This schematic shows only the structure of the filter and is not the only type specified in this Standard.
NOTE 2 The liquid filter in the anesthesia bag can be protected from a conical joint. 3.3 Marks
The product model mark consists of product name code, classification code and nominal aperture composition.
Product name code. the filter is represented by AF.
Classification code. air filter is represented by A; liquid filter by L. Marking example 1. the air filter of which the nominal pore size of the filter medium is 0.5 μm
AF-A-0.5
Marking example 2. the liquid filter of which the nominal pore size of the filter medium is 2.0 μm
AF-L-2.0
4 Materials
Materials for the production of filters and their components shall comply with the requirements of Clause 5. For the parts in contact with the liquid, the material shall comply with the requirements of Clause 6 and Clause 7.
5 Physical requirements
5.1 Appearance
Observed by normal vision or corrected vision, the filter should be smooth on the outer surface, without burrs, impurities, cracks or other defects.
5.2 Connector
The filter connector shall comply with the provisions of GB/T 1962.1 and GB/T 1962.2.
where,
N0 - The number of particles measured in the test solution, in piece per milliliter (pc/mL);
N1 - The number of particles measured in the filtrate, in piece per milliliter (pc/mL).
A.2 Filtration rate test of air filter
A.2.1 Test instruments
Dust particle counter. the sampling tube length is 1 m; sampling time is 1 time/min.
Rotor flowmeter.
A.2.2 Test steps
Under static environmental conditions, connect the dust particle counter to the flowmeter. At an air flow rate of 50 mL/min, measure the number of
particles ≥0.5 µm in the air collected within 1 min. Read five consecutive data. Take the air filter. Connect it with flowmeter inlet according to the use direction. In the same air flow, measure the number of particles ≥0.5 µm in the air after passing through the air filter within 1 min. Read five consecutive data. Remove the maximum and minimum values of the five consecutive data.
Take the average of the remaining three data.
A.2.3 Expression of results
Equation (A.2) provides the filtration rate of air filter, in percentage. where,
N0 - average of the number of particles ≥0.5 µm in the air;
N1 - average of the number of particles ≥0.5 µm in the air after passing through the air filter.
A.3 Adhesion test
A.3.1 Adhesion test of liquid filter
Inject the distilled water from the liquid inlet of the liquid filter. Close the other Filtration rate of air filter