YY 0585.1-2005 (YY 0585.1-2019 Newer Version) PDF English
YY 0585.1-2005 (YY0585.1-2005) PDF English
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YY 0585.1-2005: PDF in English YY 0585.1-2005
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Fluid lines for use with pressure infusion
equipment and accessories for single use –
Part 1. Fluid lines
(ISO 8536-9.2004, Infusion equipment for medical use –
Part 9. Fluid lines for use with pressure infusion equipment, MOD)
ISSUED ON. DECEMBER 7, 2005
IMPLEMENTED ON. DECEMBER 1, 2006
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Designation ... 6
4 Materials ... 6
5 Physical requirements ... 6
6 Chemical requirements ... 7
7 Biological requirements ... 8
8 Packaging ... 8
9 Labelling ... 8
Annex A (Normative) Physical tests ... 10
Annex B (Normative) Chemical tests ... 12
Annex C (Normative) Biological tests ... 13
Annex NA (Informative) Test Method for Storage Volume ... 14
Annex NB (Informative) Technical Differences between this Part and ISO
8536-4.2004 as well as the Reasons ... 16
Bibliography ... 17
Foreword
This Part of YY 0585 modifies and adopts ISO 8536-9.2004 “Infusion equipment for
medical use - Part 9. Fluid lines for use with pressure infusion equipment”; the technical
differences with ISO 8536-9.2004 are detailed in Annex NB.
General title of YY 0585 is “Fluid lines for use with pressure infusion equipment and
accessories for single use”; it includes the following parts.
— Part 1. Fluid lines;
— Part 2. Accessories;
— Part 3. Filters.
Annex A, Annex B and Annex C of this Part are normative; Annex NA and NB are
informative.
This Part was proposed by National Technical Committee on Standardization of Injectors
(Needles) for Medical Devices.
This Part shall be under the jurisdiction of Jinan Medical Equipment Quality Supervision &
Inspection Centre of State Food and Drug Administration.
Drafting organization of this Part. Shandong Medical Equipment Products Quality and
Inspection Centre.
Main drafters of this Part. Wu Ping, Song Jinzi, Pan Huaxian and Wan Min.
Introduction
The storage volume involved in this Part of YY 0585 is an index to investigate the
compliance of an infusion set. When used with pressure infusion equipment, if the infusion
switch (if any) at the end is opened, the infusion set will, because of the action of the
pressure supplied by the infusion equipment, deliver excess liquid to the patient on the
instant the switch is opened. This may have an adverse effect on the patient.
The determination of storage volume shall undergo a test together with the suitable
pressure infusion equipment. This is a job that both infusion set manufacturers and
pressure infusion equipment shall do jointly.
The term “storage volume” in this Part of YY 0585 is “bolus volume” in English in IEC
60601-2-24.1998. Such explanation is helpful to further learn the related contents in IEC
60601-2-24.1998 (see also Annex NA).
The Annex NA in GB 8368 is applicable to this Part of YY 0585.
Fluid lines for use with pressure infusion equipment
and accessories for single use - Part 1. Fluid lines
1 Scope
This Part of YY 0585 applies to sterilized fluid lines for single use for use with pressure
infusion equipment up to a maximum of 200 kPa.
The following items are covered by this Part of YY 0585.
a) syringe pump lines (SPL)1);
b) connecting lines (CL);
c) lines with integrated injection cannula (LIC).
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)
GB 15811 Sterile hypodermic needles for single use (GB 15811-2001, eqv ISO
7864.1993)
GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of tests for
interactions with blood (GB/T 16886.4-2003, ISO 10993-4.2002, IDT)
YY 0585.2 Fluid lines for use with pressure infusion equipment and accessories for
single use - Part 2. Accessories (YY 0585.2-2005, ISO 8536-10.2004, IDT)
YY 0585.3 Fluid lines for use with pressure infusion equipment and accessories for
1) Infusion pumps specified in YY 0451 not in the scope of this part of YY 0585.
of at least 15 N for 15s.
5.4 Leakage
In the beginning of the test, the whole system shall be conditioned at the test temperature.
The fluid lines shall be impermeable to air, microorganisms, and fluids. When tested as
specified in A.4, there shall be no leakage of air or water.
5.5 Adapters with female and/or male conical fittings
In the beginning of the test, the whole system shall be conditioned at the test temperature.
Adapters shall be provided with a connector with female conical fitting and/or a connector
with male conical fitting according to GB/T 1962.2. When tested as specified in A.5, no
water shall leak from the point of connection.
5.6 Accessories
Accessories of fluid lines, other than infusion filters, shall comply with the requirements as
specified in YY 0585.2.
5.7 Filters
Infusion filters shall comply with the requirements as specified in YY 0585.3.
5.8 Storage volume
The storage volume shall be determined in accordance with IEC 60601-2-24 and shall be
stated according to 9.1 g).
NOTE. Test methods specified in IEC 60601-2-24 are given in Annex NA, however, test liquid should be
carried out under 40°C.
5.9 Injection needles
Injection needles shall comply with GB 18671 or GB 15811 when tested as specified in
A.6.
5.10 Protective caps
GB 8368 applies.
6 Chemical requirements
GB 8368 applies, test methods see Annex B.
Annex A
(Normative)
Physical tests
A.1 Test for transparency
Fill the fluid line with distilled water. Inspect visually whether the air-water interface is
detectable.
A.2 Test for particulate contamination
The volume of rinse fluid shall be at least 50 times the inner volume of a test specimen.
The test shall be performed as specified in GB 8368.
A.3 Test for tensile strength
Expose the fluid lines in longitudinal direction to a static tensile force of 15 N for 15 s.
Inspect whether points of connection and components withstand the test force applied.
A.4 Tests for leakage
A.4.1 In the beginning of the test, condition the whole system at the test temperature.
A.4.2 Connect the fluid lines with the air supply and close all other openings. Apply air with
an internal excess pressure of 50 kPa at (23 ± 1)°C and (40 ± 1)°C to the fluid lines for 15
s. Inspect the fluid lines for any leakage of air under water.
A.4.3 Fill the fluid lines with distilled water and apply an internal excess pressure of 200
kPa at (23 ± 1)°C and (40 ± 1)°C for 15 min. Inspect the fluid lines for any leakage of
water.
A.4.4 Fill the fluid lines with degassed, distilled water, connect it with its openings sealed
to a vacuum device and subject it to an internal excess pressure of -20 kPa at (23 ± 1)°C
and (40 ± 1)°C for 15 s. Inspect whether air enters the fluid lines.
NOTE. Atmospheric pressure shall be the reference pressure. Excess pressure, according to ISO 31-3,
can assume positive or negative values.
A.5 Testing for leakage of adapters with female and/or male conical fittings
A.5.1 In the beginning of the test, condition the whole system at the test temperature.
A.5.2 Test the female and/or male conical fitting of the adapter with the reference
connector according to GB/T 1962.2. Test the conical connection for 15 min, using distilled
water under internal excess pressure of 200 kPa at (23 ± 1)°C and (40 ± 1)°C. Inspect it
Annex B
(Normative)
Chemical tests
B.1 Preparation of test fluids
Take 450 cm of tubing and the equivalent of 100 cm2 of surface of all the other
components, e.g. connecting pieces. Disassemble the sterilized, ready-to-use fluid line
into those pieces which will be in contact with the infusion fluid. Then arrange t...
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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