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YY 0585 consists of the following parts under the general title Fluid lines for use with pressure infusion equipment and accessories for single use:
——Part 1: Fluid lines;
——Part 2: Accessories;
——Part 3: Filters;
——Part 4: Check valves.
This is Part 2 of YY 0585.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0585.2-2005. An informative Annex D is added behind Annexes A, B and C, and in addition to editorial changes, the following main technical changes have been made with respect to YY 0585.2-2005.
——The degree of standard adoption is modified from “IDT” (identical adoption) to “MOD” (modified adoption);
——The marking of Clause 3 is deleted;
——The requirements for unit with injection site in 4.8 are modified;
——The requirements for unit with check valve in 4.9 are modified, and A.8 is deleted;
——The biological requirements in Clause 6 is modified to be applicable to GB 8368 to facilitate implementation;
——The labeling requirements in Clause 8 are modified. The requirement that the symbol 2725 of ISO 7000 can be used to indicate the presence of a substance of concern is added;
——The disposal requirements in Clause 9 are added;
——The method of test for leakage in A.4 is modified and the negative pressure test is deleted;
——The leakage test for adapters with female and/or male conical fittings in A.5 is deleted.
This part is modified in relation to ISO 8536-10: 2015 Infusion equipment for medical use—Part 10: Accessories for fluid lines for single use with pressure infusion equipment.
Technical differences have been made in this part with respect to ISO 8536-10: 2015, and relevant technical differences and their causes have been listed in Annex D.
The following editorial changes have been made in this part:
——Informative Annex D is added, giving a list of corresponding technical differences and their causes compared with ISO 8536-10: 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this standard shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This part is under the jurisdiction of the National Technical Committee 106 on Medical Syringes of Standardization Administration of China.
The previous edition of this part is as follows:
——YY 0585.2-2005.
Fluid lines for use with pressure infusion equipment and accessories for single use—
Part 2: Accessories
1 Scope
This part of YY 0585 specifies the physical, chemical and biological requirements of accessories for pressure infusion equipment.
This part applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in YY 0286.4, including:
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 or adapters.
2 Normative references
The following documents are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 1962.21) Conical fitting with a 6% (Luer) taper for syringes, needles and certain other medical equipment—Part2: Lock fittings (GB/T 1962.2-2001, ISO 594-2: 1998, IDT)
GB 8368 Infusion sets for single use—Gravity feed (GB 8368-2018, ISO 8536-4: 2010, MOD)
YY 0286.4 Special infusion sets—Part 4: Infusion sets for single use pressure infusion apparatus (YY 0286.4-2006, ISO 8536-8: 2004, IDT)
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YY/T 0466.1 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements (YY/T 0466.1-2016, ISO 15223-1: 2012, IDT)
YY 0585.4 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 4: Accessories (YY 0585.4-2009, ISO 8536-12: 2007, MOD)
Pharmacopoeia of the People's Republic of China
3 Materials
The materials from which the accessories are manufactured shall comply with the requirements as specified in Clause 4, Clause 5, and Clause 6.
4 Physical requirements
4.1 Avoidance of air bubbles
All components of accessories shall be designed such that no air bubbles are detected in flow channels when tested as specified in A.1.
4.2 Particulate contamination
The accessories shall be manufactured under conditions that minimize particulate contamination. The fluid pathway surfaces shall be smooth and clean. When tested as specified in A.2, the number of particles shall not exceed the contamination index.
4.3 Tensile strength
When tested as specified in A.3, the accessories and connections (except for protective caps) between components shall withstand a static tensile force of not less than 15N for 15s.
In the case of stopcocks, connections between plug and housing shall withstand this tensile force when in any position.
4.4 Leakage
The accessories shall be impermeable to air, microorganisms, and fluids. Stopcocks shall be tight in any plug position. When tested as specified in A.4, there shall be no leakage of air or water.
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4.5 Adapters with female and/or male conical fittings
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.
4.6 Protective caps
GB/T 8368 applies.
4.7 Manipulation of stopcocks
Stopcocks and stopcock manifolds shall be so designed that when tested as specified in A.5, flow channels can be opened and closed without any adverse effect on the functionality of adjacent components.
4.8 Unit with injection site
Units with injection site shall enable injection. When tested as specified in A.6, no more than 2 drops per unit shall be lost.
4.9 Unit with check valve
Unit with check valve shall meet the requirements specified in YY 0585.4.
5 Chemical requirements
GB 8368 applies. For test methods, see Annex B.
6 Biological requirements
GB 8368 applies. For test methods, see Annex C.
Foreword i
1 Scope
2 Normative references
3 Materials
4 Physical requirements
5 Chemical requirements
6 Biological requirements
7 Packaging
8 Labeling
9 Disposal
Annex A (Normative) Physical tests
Annex B (Normative) Chemical tests
Annex C (Normative) Biological tests
Annex D (Informative) Technical differences between this part and ISO 8536-10: 2015 and their causes
Bibliography
