YY/T 0294.1-2024Surgical instruments - Materials - Part 1: Metals (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 is part 1 of YY/T 0294 Surgical instruments - Materials. YY/T 0294 has

been published in the following parts.

-- Part 1.Metals.

This document replaces YY/T 0294.1-2016 Surgical instruments - Metallic materials -

Part 1.Stainless steel. Compared with YY/T 0294.1-2016, in addition to structural

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

-- The overview is deleted (see Chapter 3 of the 2016 edition);

-- The scope of application of materials is added (see Chapter 4);

-- The table of the applicable scope of stainless steel is modified (see Table 1; see

Table 1 of the 2016 edition);

-- The table of the applicable scope of cemented carbide is added (see Table 2);

-- The table of the applicable scope of titanium and titanium alloys is added (see

Table 3);

-- The chapter "Materials" is added (see Chapter 5);

-- The chapter "Chemical composition" is deleted (see Chapter 4 of the 2016

edition);

-- The table of the stainless steel is added (see Table 4);

-- The table of the correspondence between EN 10088-1.2014 and other standards

is added (see Table 5);

-- The table of cemented carbide is added (see Table 6);

-- The table of titanium and titanium alloys is added (see Table 7).

This document is modified in relation to ISO 7153-1.2016 Surgical instruments -

Materials - Part 1.Metals.

This document has made the following structural adjustments compared to ISO 7153-

1.2016.

-- Chapter 4 corresponds to Chapter 3 of ISO 7153-1.2016;

-- Chapter 5 corresponds to Chapter 4 of ISO 7153-1.2016.

The technical differences between this document and ISO 7153-1.2016 and their

reasons are as follows.

-- The normative reference GB/T 4340.1 replaces ISO 6507-1 (see Table 4). The

degree of consistency between the two documents is modification;

-- The normative reference GB/T 230.1 replaces ISO 6508-1 (see Table 4). The

degree of consistency between the two documents is modification;

-- GB/T 20878-2007 is added (see Chapter 4, Table 1 and Table 4);

-- Chinese stainless-steel grades are added to adapt to Chinese technical conditions

and meet the selection of surgical instrument materials in China;

-- The applicability of 12Cr18Ni9 stainless steel components is added to adapt to

Chinese technical conditions and meet the selection of surgical instrument

components in China (see Table 1).

The following editorial changes were made to this document.

-- Examples of forceps and forceps with inserts or coatings are added (see Table

1~Table 3).

1 Scope

This document gives examples of conventional stainless-steel materials, cemented

carbides, titanium and titanium alloys used to manufacture various standard surgical

instruments and components, as well as information on grades and hardness ranges of

commonly used materials.

This document applies to the selection of metal materials used in the manufacture of

surgical instruments, including but not limited to general surgical, orthopedic, and

dental instruments.

NOTE 1.Although this document is not intended to apply to surgical instruments for special applications

such as implantology and minimally invasive surgery, some parts of it may be applicable to these

instruments.

NOTE 2.When selecting metal materials, manufacturers need to consider the instrument design and

factory manufacturing in addition to the metal grade, shape, size, and delivery status. Therefore,

manufacturers are responsible for the selection of materials and shall not exclude the possibility of

referring to other current standards. When appropriate standards are released, the applicability of new

standards needs to be considered.

2 Normative references

The provisions of the following documents constitute the essential clauses of this

document through normative references in this text. Among them, for referenced

documents with dates, only the versions corresponding to the dates are applicable to

this document; for referenced documents without dates, the latest versions (including

all amendments) are applicable to this document.

GB/T 230.1 Metallic materials - Rockwell hardness test - Part 1.Test method

(GB/T 230.1-2018, ISO 6508-1.2016, MOD)

GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1.Test method (GB/T

4340.1-2009, ISO 6507-1.2005, MOD)

GB/T 20878-2007 Stainless and heat-resisting steels - Designation and chemical

composition

ISO 5832-2 Implants for surgery - Metallic materials - Part 2.Unalloyed titanium

ISO 5832-3 Implants for surgery - Metallic materials - Part 3.Wrought titanium 6-

aluminium 4-vanadium alloy

ASTM B 265 Standard Specification for Titanium and Titanium Alloy Strip, Sheet, and Plate

ASTM B 348 Standard Specification for Titanium and Titanium Alloy Bars and Billets

EN 10088-1.2014 Stainless steels Part 1.List of stainless steels

3 Terms and definitions

There are no terms or definitions that require definition in this document.

4 Scope of application of materials

Because various surgical instruments have different needs and different requirements

for the materials used to make them, not all materials listed in Chapter 5 are suitable

for every type of instrument. For most types of surgical instruments, Tables 1~3 give

materials that are suitable for these instruments based on known experience. Other

materials may also be suitable for the manufacture of certain types of instruments,

although these materials are not included in this document.

Table 1 lists the conventional stainless-steel materials used to manufacture various

standard surgical instruments and components. The codes in the first column

correspond to the stainless-steel materials specified in Table 4.In addition, the codes in

the second column are from ISO 7153-1.1991, and the grades in the third column are

from GB/T 20878-2007.The information in the second and third columns is only for

users familiar with YY/T 0294.1-2016.

5 Materials

Table 4 gives the grades of commonly used stainless steels for various surgical instruments. In addition, the Rockwell hardness and Vickers hardness

values of the materials are given where possible.

a For the conversion between Rockwell hardness value and Vickers hardness value, refer to Table A.1 of GB/T 33362-2016.1 HRC is added to

the calculated HV5/HV10 value (based on the empirical value of stainless steel). This document does not give the Vickers hardness values of

other loads.

b Material numbers in brackets are not included in EN 10088-1; the materials are included in this table only.

c Historically, material number 1.4121 has been used in other areas, but the material grade is the same. 1.4197 is used for rotating surgical tools.

Code (see Table 1)

Table 5 gives the material classification correspondence between EN 10088-1.2014 and

other relevant steel standards. All information in Table 5 is for reference only by users

of this document and is not normative. The second column establishes a correspondence

between the material number of EN 10088-1.2014 and the material code and chemical

composition given in ISO 7153-1.1991.Since the material number in EN 10088-1.2014

does not directly correspond to the code in ISO 7153-1.1991 in all cases, the third and

fifth columns give indications when the chemical composition is the same, very similar

or essentially different.

Appendix A

(Informative)

Examples of dental instruments

YY/T 0294.1-2016 lists detailed surgical instruments and examples of stainless steel

commonly used in processing. This information is particularly helpful for dental

instruments. In some cases, dental instruments cannot be simply classified into the

instrument types given in Table 1.Therefore, when updating this part of the information,

the application examples of dental instruments are given in Table A.1.For commonly

used component materials, refer to Table 1 and Table 3.

......