YY 0585.2-2005_English: PDF (YY0585.2-2005)
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Fluid lines for use with pressure infusion equipment and accessories for single use - Part 2: Accessories
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YY 0585.2-2005
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YY 0585.2-2005
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| Standard ID | YY 0585.2-2005 (YY0585.2-2005) | | Description (Translated English) | Fluid lines for use with pressure infusion equipment and accessories for single use - Part 2: Accessories | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 9,916 | | Date of Issue | 2005-12-07 | | Date of Implementation | 2006-12-01 | | Adopted Standard | ISO 8536-10-2004, 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 single-use sterile fluid path and YY 0286. 4 predetermined pressure infusion Used accessories. YY 0585 This part includes: a) two-way switch (2SC), three-way switch (3SC), four digital (4SC) and multi Switch (SM), b) seat with injection device (UIS) or with backflow preventer devices (UCV), c) plug (S) or connector (A). | YY 0585.2-2005
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
YY 0585.2-2005 / ISO 8536-10.2004
Fluid lines for use with pressure infusion
equipment and accessories for single use –
Part 2. Accessories
(ISO 8536-10.2004, Infusion equipment for medical use – Part 10.
Accessories for fluid lines for use with pressure infusion equipment, IDT)
ISSUED ON. DECEMBER 07, 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 ... 5
4 Materials ... 6
5 Physical requirements ... 6
6 Chemical requirements ... 7
7 Biological requirements ... 7
8 Packaging ... 7
9 Labelling ... 7
Annex A (Normative) Physical tests ... 10
Annex B (Normative) Chemical tests ... 12
Annex C (Normative) Biological tests ... 13
Bibliography ... 14
Fluid lines for use with pressure infusion equipment
and accessories for single use - Part 2. Accessories
1 Scope
This Part of YY 0585 applies to sterilized accessories for single use in fluid lines and
pressure infusion equipment as specified in YY 0286.4.
This Part of YY 0585 includes.
a) Two-way stopcocks (2SC), three-way stopcocks (3SC), four-way stopcocks (4SC)
and stopcocks manifold (SM);
NOTE. Designation of a stopcock depends on the number of connections. The number of possible
functional positions can be expressed by addition of a complementary note, using a diagonal
stroke and a numeral indicating the number of possible stopcock positions, e.g. 3/4-way stopcock
for three-way stopcock with four possible positions.
b) units with injection site (UIS) or check valve (UCV);
c) stoppers (S) or adapters (A).
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 15810 Sterile hypodermic syringes for single use - Part 1. Syringes for manual use
(GB 15810-2001, eqv ISO 7886-1.1993)
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)
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
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