YY 0585.3-2005 English PDF (YY0585.3-2005)

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YY 0585.3-2005: Fluid lines for use with pressure infusion equipment and accessories for single use - Part 3: Filters
YY 0585.3-2005
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
YY 0585.3-2005 / ISO 8536-11.2004
Fluid lines for use with pressure infusion
equipment and accessories for single use –
Part 3. Filters
(ISO 8536-11.2004, Infusion equipment for medical use –
Part 11. Infusion filters for use with pressure infusion equipment, IDT)
ISSUED ON. DECEMBER 7, 2005
IMPLEMENTED ON. DECEMBER 1, 2006
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Designation ... 4 
4 Design... 4 
5 Materials ... 5 
6 Physical requirements ... 5 
7 Chemical requirements ... 5 
8 Biological requirements ... 5 
9 Packaging... 6 
10 Labelling ... 6 
Annex A (Normative) Physical tests ... 8 
Annex B (Normative) Chemical tests ... 10 
Annex C (Normative) Biological tests ... 11 
Bibliography ... 12 
Fluid lines for use with pressure infusion equipment and
accessories for single use - Part 3. Filters
1 Scope
This Part of YY 0585 applies to sterilized infusion filters for single use up to 200 kPa (2 bar)
on fluid lines of pressure infusion equipment and infusion set as specified in YY 0286.4. It
does not include the effectiveness of filters for separation of particles or germs.
2 Normative references
The articles contained in the following documents have become part of this Part of YY
0585 when they are quoted herein. For the dated documents so quoted, all the
modifications (excluding corrections) or revisions made thereafter shall not be applicable
to this Part. For the undated documents so quoted, the latest editions shall be applicable
to this Part.
GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain
other medical equipment - Part 2. Lock fittings (GB/T 1962.2-2001, idt ISO 594-2.1994)
GB 8368 Infusion sets for single use, gravity feed (GB 8368-2005, ISO 8536-4.2004,
MOD)
YY 0286.4 Special infusion sets - Part 4. Single-use infusion equipment for use with
pressure infusion apparatus (YY 0286.4-2006, ISO 8536-8.2004, IDT)
YY 0466 Medical devices - Symbols to be used with medical device labels, labelling
and information to be supplied (YY 0466-2003, ISO 15223.2000, IDT)
3 Designation
Designation of an infusion filter (IF) for infusions under pressure (P).
Infusion filter YY 0585.3-IF-P
4 Design
The infusion filter housing shall be provided with a venting system to anticipate the
blocking of the filter by the accumulation of air bubbles.
Bibliography
[1] GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of tests for
interactions with blood (GB/T 16886.4-2003, ISO 10993-4, IDT)
[2] GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical
use - Part 2.Biological test methods
[3] GB 18278-2000 Sterilization of health care products - Requirements for validation
and routine control - Industrial moist heat sterilization (idt ISO 11134.1994)
[4] GB 18279-2000 Medical devices - Validation and routine control of ethylene oxide
sterilization (idt ISO 11135.1994)
[5] GB 18280-2000 Sterilization of health care products - Requirements for validation
and routine (idt ISO 11137.1995)
[6] GB/T 6682-1992 Water for analytical laboratory use - Specification and test methods
(neq ISO 3696.1997)
[7] Chinese Pharmacopoeia
[8] ISO 31-3 Quantities and units - Part 3. Mechanics