This document specifies the requirements for spinal needle with a nominal outer diameter of 0.40mm to 1.60mm, used for puncture and drug liquid injection during subarachnoid block (hereinafter referred to as lumbar anesthesia) for human beings.
This document is applicable to reusable spinal needles.
This document is not applicable to disposable spinal needles for anesthesia.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 18457 Stainless steel needle tubing for the manufacture of medical devices
YS/T 76 Lead brass drawn rods with tooth pattern
YY/T 0916.6 Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
3 Terms and definitions
No terms and definitions are listed in this document.
4 Structure and classification
4.1 Structural types
The structural style and components of spinal needle are as shown in Figure 1.
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Structure and classification 4.1 Structural types 4.2 Basic dimensions 4.3 Designation 5 Materials 6 Requirements and test methods 6.1 Appearance 6.2 Dimension 6.3 Needle base and cartridge base 6.5 Needle tip 6.6 Fitting 6.7 Connection fastness 6.8 Scale line 7 Sterilization 8 Marking 8.1 Primary package 8.2 Shelf package or multi-unit package 9 Packaging 10 Transportation and storage Bibliography
YY/T 1148-2024 Spinal needle
1 Scope
This document specifies the requirements for spinal needle with a nominal outer diameter of 0.40mm to 1.60mm, used for puncture and drug liquid injection during subarachnoid block (hereinafter referred to as lumbar anesthesia) for human beings.
This document is applicable to reusable spinal needles.
This document is not applicable to disposable spinal needles for anesthesia.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 18457 Stainless steel needle tubing for the manufacture of medical devices
YS/T 76 Lead brass drawn rods with tooth pattern
YY/T 0916.6 Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
3 Terms and definitions
No terms and definitions are listed in this document.
4 Structure and classification
4.1 Structural types
The structural style and components of spinal needle are as shown in Figure 1.
Contents of YY/T 1148-2024
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Structure and classification
4.1 Structural types
4.2 Basic dimensions
4.3 Designation
5 Materials
6 Requirements and test methods
6.1 Appearance
6.2 Dimension
6.3 Needle base and cartridge base
6.5 Needle tip
6.6 Fitting
6.7 Connection fastness
6.8 Scale line
7 Sterilization
8 Marking
8.1 Primary package
8.2 Shelf package or multi-unit package
9 Packaging
10 Transportation and storage
Bibliography
