YY/T 0294.1-2016 English PDF (YYT0294.1-2016)

This Part of YY/T 0294 contains a selection of stainless steels for use in the design and manufacture of surgical instruments. When selecting stainless steel materials for manufacturing surgical instruments, as required by instrument design, it is allowed to select the materials not covered by this Part. Therefore, the content of this Part is not the only basis for selecting raw materials for manufacture. When the manufacturer is selecting stainless steels, it shall also consider relevant material standards for surgical instruments which shall be observed and take responsibilities for the materials selected.

YY/T 0294.1-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 31
Replacing YY/T 0294.1-2005
Surgical instruments - Metallic materials -
Part 1. Stainless steel
(ISO 7153-1.1991, MOD)
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 3
1 Scope .. 5
2 Normative References . 5
3 Overview . 5
4 Chemical composition . 8
Foreword
YY/T 0294, Surgical instruments - Metallic materials, comprises the following parts. -- Part 1. Stainless steel;
-- Subsequent parts will be made in succession.
This Part is Part 1 of YY/T 0294.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009. This Part replaces YY/T 0294.1-2005, Surgical instruments - Metallic materials - Part 1. Stainless steel.
The major differences between this Part and YY/T 0294.1-2005 are as follows. -- the normative references of Clause 2 are added;
-- the national grade numbers corresponding to all types of stainless steels are added in Table 1 and Table 2.
Based on translated versions, this Part modifies and adopts ISO 7153-1.1991, Surgical instruments - Metallic materials - Part 1. Stainless steel, and A1.1999. The major differences between them are as follows.
-- the application scope is “surgical instruments”;
-- it deletes the normative reference documents of the international standard, because ISO 683-13.1986 and ISO 4957.1980 are abolished;
-- the national grade numbers corresponding to all types of stainless steels are added in Table 1 and Table 2.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuer of this document shall not be held responsible for identifying any or all such patent rights.
This Part was proposed and shall be under the jurisdiction of National Technical Committee 94 on Surgical Instruments of Standardization Administration of China (SAC/TC 94).
The drafting organizations of this Part. Shanghai Testing and Inspection Institute for Medical Devices, Shanghai Medical Instruments (Group) Ltd., Corp. Surgical Instruments Factory.
The main drafters of this Part Lu E, Huang Lili, Pan Weirong, Wang Zewei. The previous editions of the standard replaced by this Standard are as follows. Surgical instruments - Metallic materials -
Part 1. Stainless steel
1 Scope
This Part of YY/T 0294 contains a selection of stainless steels for use in the design and manufacture of surgical instruments.
NOTE. When selecting stainless steel materials for manufacturing surgical instruments, as required by instrument design, it is allowed to select the materials not covered by this Part. Therefore, the content of this Part is not the only basis for selecting raw materials for manufacture. When the manufacturer is selecting stainless steels, it shall also consider relevant material standards for surgical instruments which shall be observed and take responsibilities for the materials selected.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition dated applies to this document. For undated references, the latest edition of the referenced documents (including all amendments) applies to This Standard.
GB/T 20878-2007, Stainless and heat-resisting steels - Designation and chemical composition
3 Overview
For the reference letters (grade numbers) and application examples of stainless steels, see Table 1.
Table 1 -- Reference letters (grade numbers) of stainless steel
Reference letter of
steel grade
ISO 7153-1.1991
Grade no.
GB/T 20878-2007
Application examples
Cutting instruments Non-cutting instruments
Fitting parts and
other assemblies
A 12Cr13 -
tissue forceps,
dressing forceps,
probes,
dental tweezers
rivets,
solid pins,
guide pins,
screws, nuts
B 20Cr13 bone rongeurs, forceps,