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
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.
Contents of GB 8368-2005
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
