YY 0286.4-2006_English: PDF (YY0286.4-2006)
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| YY 0286.4-2006 | English | 150 |
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Special infusion sets - Part 4: Single-use infusion equipment for use with pressure infusion apparatus
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YY 0286.4-2006
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| YY/T 0286.4-2020 | English | 260 |
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Special infusion sets -- Part 4: Infusion sets for single use with pressure infusion apparatus
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YY/T 0286.4-2020
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Newer version: YY 0286.4-2020 Standards related to: YY 0286.4-2020
| Standard ID | YY 0286.4-2006 (YY0286.4-2006) | | Description (Translated English) | Special infusion sets - Part 4: Single-use infusion equipment for use with pressure infusion apparatus | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 13,111 | | Date of Issue | 2006-04-19 | | Date of Implementation | 2007-04-01 | | Quoted Standard | GB/T 1962.2; GB 8368; YY 0466; GB 9706.27 | | Adopted Standard | ISO 8536-8-2004, IDT | | Drafting Organization | Shandong Province Quality Inspection Center of Medical Devices | | Administrative Organization | National Technical Committee of Standardization for medical infusion | | Regulation (derived from) | SFDA [2006] No. 157 | | Proposing organization | National Standardization Technical Committee appliances Infusion | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the following sterile supply for 200kPa pressure infusion equipment Disposable Infusion (hereinafter referred to as: Infusion) requirements. | YY 0286.4-2006
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
YY 0286.4-2006 / ISO 8536-8.2004
Special infusion sets - Part 4. Single-use
infusion equipment for use with pressure
infusion apparatus
(ISO 8536-8.2004, Infusion equipment for medical use –
Part 8. Infusion equipment for use with pressure infusion apparatus, IDT)
ISSUED ON. APRIL 19, 2006
IMPLEMENTED ON. APRIL 1, 2007
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
5 Materials ... 9
6 Physical requirements ... 9
7 Chemical requirements ... 10
Annex A (Normative) Physical tests ... 13
Annex B (Normative) Chemical tests ... 15
Annex C (Normative) Biological tests ... 16
Annex NA (Informative) Test Method for Storage Volume ... 17
Bibliography ... 19
Introduction
With the ever developing infusion techniques and increasingly improved clinical
requirements, some dedicated infusion sets applicable to special clinical requirements
have appeared in succession. The YY 0286 standard is specifically devised to standardize
these dedicated infusion sets. As the development of infusion sets is endless, it is
impossible to expect to have every dedicated infusion set having special requirements
covered in one standard alone. Therefore, every part of YY 0286 works for only one
special clinical requirement to standardize these dedicated infusion sets. In case one
infusion set falls into these having various special purposes as well, it shall conform to the
applicable parts in YY 0286.
The storage volume involved in this Part of YY 0286 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 0286 is “bolus volume” in English in GB
9706.27-2005. Such explanation is helpful to further learn the related contents in GB
9706.27-2005 (see also Annex NA).
The Annex NA in GB 8368 is applicable to this Part of YY0286.
Special infusion sets - Part 4. Single-use infusion equipment
for use with pressure infusion apparatus
1 Scope
This Part of YY 0286 gives users information on sterilized infusion sets for single use with
pressure infusion equipment (hereinafter referred to as infusion set) up to a maximum of
200 kPa.
2 Normative references
The articles contained in the following documents have become part of this Part of YY
0286 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, GB 8368-2005, ISO
8536-4.2004, MOD)
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)
GB 9706.27 Medical electrical equipment - Part 2-24. Particular requirements for the
safety of infusion pumps and controllers (GB 9706.27-2005, IEC 60601-2-24.1998, IDT)
3 General requirements
3.1 The nomenclature to be used for components of infusion sets and of a separate
air-inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the
configuration of infusion sets and air-inlet devices; other configurations may be used
provided they lead to the same results. Infusion sets as illustrated in Figure 2 should only
be used for collapsible plastics containers. Infusion sets as illustrated in Figure 2 used
with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in
Figure 1 shall be used for rigid containers.
collection vessel shall be emptied.
NA.4 The switch is opened to gather the storage volume generated because of switch
closing before the pressure reduces to atmospheric pressure.
If the equipment instructions offer the methods of eliminating storage volume before the
infusion set is opened, the storage volume shall be first eliminated according to the
methods described in the instructions before the residual storage volume is measured.
Bibliography
[1] ISO 31-3 Quantities and units - Part 3. Mechanics
[2] GB 18278-2000 Sterilization of health care products - Requirements for validation
and routine control - Industrial moist heat sterilization (idt ISO 11134.1994)
[3] GB 18279-2000 Medical devices - Validation and routine control of ethylene oxide
sterilization (idt ISO 11135.1994)
[4] GB 18280-2000 Sterilization of health care products - Requirements for validation
and routine (idt ISO 11137.1995)
[5] GB/T 6682-1992 Water for analytical laboratory use - Specification and test methods
(neq ISO 3696.1997)
[6] YY 0451 Portable infusion devices for single use
[7] Chinese Pharmacopoeia
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