GB/T 18457-2024Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (English PDF)

Foreword

This document was drafted in accordance with the provisions of GB/T 1.1-2020

"Directives for standardization - Part 1.Rules for the structure and drafting of

standardizing documents".

This document replaces GB/T 18457-2015 "Stainless steel needle tubing for the

manufacture of medical devices". Compared with GB/T 18457-2015, in addition to

structural adjustments and editorial changes, the main technical changes are as follows.

a) CHANGE the scope, ADD the size of 0.18 mm (34G) (see Chapter 1; Chapter 1

of the 2015 edition);

b) ADD the terms and definitions (see Chapter 3);

c) CHANGE the requirements for materials (see Chapter 4; Chapter 4 of the 2015

edition);

d) ADD the size requirements for ultra-thin walls and very thin walls of some

specifications (see Chapter 5);

e) ADD the specific size requirements for the nominal outer diameter of 0.18 mm

needle tubes (see Table 1);

f) CHANGE the requirements for size marking (see 5.5; Chapter 5 of the 2015

edition);

g) CHANGE the needle tube size and stiffness parameter table (see 5.7; Chapter 9

of the 2015 edition);

h) CHANGE the relevant requirements for the preparation method of the test

solution (see Appendix B; Appendix B of the 2015 edition);

i) DELETE the "Test method for pH of needle tubes" (see Appendix C of the 2015

edition);

j) CHANGE the test method and requirements for needle tube stiffness (see

Appendix C; Appendix D of the 2015 edition);

k) CHANGE the test method and requirements for needle tube toughness (see

Appendix D; Appendix E of the 2015 edition);

l) CHANGE the requirements for the needle tube corrosion resistance test report (see

E.4; F.4 of the 2015 edition).

This document modifies and adopts ISO 9626.2016 "Stainless steel needle tubing for

the manufacture of medical devices - Requirements and test methods".

Compared with ISO 9626.2016, this document has made the following structural

adjustments.

- DELETE 5.7 of ISO 9626.2016, the subsequent article numbers have been moved

forward;

- ADD the Appendix A;

- Appendix B corresponds to Appendix A of ISO 9626.2016;

- Appendix C corresponds to Appendix B of ISO 9626.2016;

- Appendix D corresponds to Appendix C of ISO 9626.2016;

- Appendix E corresponds to Appendix D of ISO 9626.2016;

- DELETE the Appendix E of ISO 9626.2016.

The technical differences between this document and ISO 9626.2016, as well as their

reasons, are as follows.

- CHANGE the material requirements, to meet domestic technical conditions (see

Chapter 4; Chapter 4 of ISO 9626.2016);

- DELETE the requirements of 5.7 "Sample size" in ISO 9626.2016, to avoid

ambiguity with 5.1 General;

- USE the normative reference GB/T 6682 to replace ISO 3696 (see B.2.1), to adapt

to China's national conditions;

- CHANGE the toughness requirements, to meet domestic technical requirements

(see Appendix D; Appendix C of ISO 9626.2016).

This document has made the following editorial changes.

- DELETE the notes in Chapter 4 of ISO 9626.2016;

- ADD the "Stainless steel designations" (see Appendix A);

- DELETE the informative Appendix E of ISO 9626.2016 "Basic principles of

needle tube stiffness test method".

Please note that some contents of this document may involve patents. The issuing

agency of this document does not assume the responsibility for identifying patents.

This document was proposed by the State Food and Drug Administration.

This document shall be under the jurisdiction of the National Technical Committee for

Standardization of Medical Syringes (Needles) (SAC/TC 95).

This standard replaces the standard previously issued as follows.

- It was first published in 2001 as GB 18457-2001; it was revised for the first time

in 2015;

- This is the second revision.

1 Scope

This document specifies the requirements for stainless steel needle tubes (hereinafter

referred to as needle tubes), which have designated metric sizes ranging from 0.18 mm

(34G) to 3.4 mm (10G); describes the test methods.

2 Normative references

The contents of the following documents constitute essential provisions of this

document through normative references in the text. Among them, for dated references,

only the version corresponding to that date applies to this document; for undated

references, the latest version (including all amendments) applies to this document.

GB/T 6682 Water for analytical laboratory use - Specification and test methods

(GB/T 6682- 2008, ISO 3696.1987, MOD)

ISO 15510.2014 Stainless steels - Chemical composition

3 Terms and definitions

The following terms and definitions apply to this document.

3.1

Designated metric size

The outer diameter of the needle tube as defined in Table 1.

3.2

Gauge

English (Birmingham) size.

Note. A specific gauge size corresponds to a designated metric size with specified outer

diameter limits.

4 Materials

The needle tube shall be made of austenitic stainless steels such as X2CrNi18-9,

X5CrNi18-10, X6CrNiNb18-10, X5CrNiMo17-12-2, X6CrNiMoTi17-12-2,

X6CrNiMoNb17-12-2 in accordance with ISO 15510.2014, or other austenitic stainless

steels equivalent to the above steels.

5 Requirements and test methods

The needle tube shall be selected based on the specific use and intended use using a risk

assessment approach.

When observed with normal or corrected vision, the outer surface of the needle tube

shall be smooth and free of defects; the needle tube shall be straight and regularly rounded.

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