Standard No.:	GB 8368-2005
English Name:	Infusion sets for single use, gravity feed
Chinese Name:	一次性使用输液器，重力输液式
Chinese Classification:	C31    General and microsurgical devices
Professional Classification:	GB    National Standard
ICS Classification:	11.040.20 11.040.20    Transfusion, infusion and injection equipment 11.040.20
Issued by:	AQSIQ
Issued on:	1987-7-10
Implemented on:	1988-6-1
Status:	superseded
Superseded by:	GB 8368-2018 Infusion sets for single use—Gravity feed
Superseded on:	2021-4-1
Abolished on:	2021-04-01
Superseding:	GB 8368-1998 Medical infusion sets for single use
Language:	English
File Format:	PDF
Word Count:	8000 words
Price(USD):	130.0
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Infusion Sets for Single Use, Gravity Feed 1 Scope This standard specifies requirements for single use, gravity feed infusion sets in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this standard are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. 2 Normative References The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. However parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. GB/T 1962.1 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements (GB/T 1962.1-2001, idt ISO 594-1:1986) 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 594-2:1998) GB/T 6682-1992 Water for Analytical Laboratory Use - Specification and Test Methods (neq ISO 3696:1987) GB/T 14233.1-1998 Infusion, Transfusion, Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods GB/T 14233.2 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods GB 15811-2001 Sterile Hypodermic Needles for Single Use (eqv ISO 7864:1993) 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) ISO 14644-1:1999 Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness 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. 3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or needle.

Foreword i 1 Scope 2 Normative References 3 General Requirements 4 Designation 5 Materials 6 Physical Requirements 7 Chemical Requirements 8 Biological Requirements 9 Labelling 10 Packaging Annex A (Normative) Physical Tests Annex B (Normative) Chemical Tests Annex C (Normative) Biological Tests