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YY 0585.3-2005

Chinese Standard: 'YY 0585.3-2005'
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YY 0585.3-2005English95 Add to Cart 0--15 minutes. Auto immediate delivery. Fluid lines for use with pressure infusion equipment and accessories for single use - Part 3: Filters Valid YY 0585.3-2005

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Detail Information of YY 0585.3-2005; YY0585.3-2005
Description (Translated English): Fluid lines for use with pressure infusion equipment and accessories for single use. Part 3: Filters
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C31
Classification of International Standard: 11.040.20
Word Count Estimation: 12,000
Date of Issue: 2005-12-07
Date of Implementation: 2006-12-01
Adopted Standard: ISO 8536-11-2004, IDT
Drafting Organization: Shandong Province Quality Inspection Center of Medical Devices
Administrative Organization: Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Regulation (derived from): Industry Standard Notice 2006 No. 2 (No. 74 overall)
Proposing organization: National Standard Committee on Medical Infusion Equipment
Issuing agency(ies): State Food and Drug Administration
Summary: This standard applies to the liquid line pressure infusion equipment and YY 0286. 4 on the prescribed pressure infusion infusion with a single-use sterile filters. Excluding filter to remove particles or bacterial effectiveness.

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
压力输液设备用一次性使用液路及附件
第 3 部分.过滤器
(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
ster......
Related standard:   YY 0585.1-2019  YY 0585.2-2019
   
 
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