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

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YY/T 0294.1-2016: Surgical instruments--Metallic materials--Part 1: Stainless steel
YY/T 0294.1-2016
Surgical instruments--Metallic materials--Part 1. Stainless steel
ICS 11.040.30
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0294.1-2005
Surgical instruments metal materials
Part 1. Stainless steel
Part 1. Stainlesssteel
(ISO 7153-1.1991, MOD)
Published on.2016-03-23
2017-01-01 Implementation
The State Food and Drug Administration issued
Foreword
YY/T 0294, "Surgical Instruments Metal Materials," contains the following sections.
--- Part 1. Stainless steel;
Subsequent parts will be developed one after another.
This section is Part 1 of YY/T 0294.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY/T 0294.1-2005 "Surgical Instruments, Metal Materials, Part 1. Stainless Steel."
The main differences between this section and YY/T 0294.1-2005 are as follows.
--- Add Chapter 2 normative references;
---In Table 1 and Table 2, domestic brands corresponding to various stainless steels have been added.
This section uses the translation method to modify the use of ISO 7153-1.1991 "Surgical Instruments Metal Materials Part 1. Stainless Steel" and A1.
In.1999, the main differences are as follows.
--- The scope applies to "surgical instruments";
--- Delete the normative references of international standards, because ISO 683-13.1986 and ISO 4957.1980 have been repealed;
---In Table 1 and Table 2, domestic brands corresponding to various stainless steels have been added.
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume responsibility for identifying these patents.
This part is proposed and managed by the National Surgical Instruments Standardization Technical Committee (SAC/TC94).
This section drafted by. Shanghai Medical Device Testing, Shanghai Medical Devices (Group) Co., Ltd. surgical instruments factory.
The main drafters of this section. Lu Hao, Huang Lili, Pan Weirong, and Wang Zexi.
The previous versions of the standards replaced in this section were.
---YY/T 0294.1-1997, YY/T 0294.1-2005.
Surgical instruments metal materials
Part 1. Stainless steel
1 Scope
This part of YY/T 0294 is for the selection of stainless steel materials when designing and manufacturing surgical instruments.
Note. When manufacturing stainless steel materials for surgical instruments, if it is necessary for the design of the instrument, it is allowed to use materials other than this part. Therefore, the content of this part is not applicable.
The only basis for making materials. Manufacturers should also consider materials that meet the relevant surgical instrument standards when selecting stainless steel materials and respond to selected materials.
Be responsible for.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 20878-2007 Stainless Steel and Heat Resistant Steel Grades and Chemical Composition
3 Overview
Stainless steel material code (plate number) and applicable examples, see Table 1.
Table 1 Stainless Steel Code (Grade)
Code number
ISO 7153-1.1991
Grade
GB/T 20878-2007
Applicable example
Cutting instruments Non-cutting instrument connectors or other accessories
A 12Cr13 -
Organization, accessories, retraction
, probe, dental file
Rivets, solid handles, positioning pins,
Screws, nuts
B 20Cr13
- 05Cr17Ni4Cu4Nb
Bone rongeur, scissors, turbinate
Pliers, chisels and gouges, bone curettes,
Carbide Scissors
Pliers, finger ring pliers, instrument pliers,
Retractor, probe, extraction forceps,
Technician Orthodontic Forceps, Probing
Needles, Stiffeners, Fillers, Teeth
Branch forceps
Spring, solid handle, screw, screw
Caps and Rivets
30Cr13
32Cr13Mo
Bone rongeurs, scissors, scrapers, teeth
Curettes, dental chisels
Technician Orthodontic Forceps, Probing
Needle, dental forceps, tooth extraction forceps, teeth
Ting, stuffer
D 40Cr13
Scissors, rongeurs, scissors,
Nasal clamp, scalpel, knife, chisel
And round chisel, bone curette, steel wire
Clamp, scraper, dental curette, dental
Chisels, drill bits, taps, buried
Drill
Stiffeners, tooth probes, fillers -
Table 1 (continued)
Code number
ISO 7153-1.1991
Grade
GB/T 20878-2007
Applicable example
Cutting instruments Non-cutting instrument connectors or other accessories
E - Scalpel - -
F - Scalpel - -
G -
Scalpels, chisels and gouges,
scissors
- - -
H -
Scissors, rongeurs, turbinates,
Chisels and gouges, bone curettes, steel
Wire clamps, drill bits, taps, buried
Drill
- - -
I -
Scissors, rongeurs, scissors,
Nasal clamp, scalpel, knife, chisel
And round chisel, bone curette, steel wire
Pliers, drill bits, taps, countersink
- - -
K - Chisels and Gouges, Bone Curettes - -
Y10Cr17
10Cr17
- - -
Solid handles, guide pins, screws,
Nuts
M 06Cr19Ni10 - Retractor, impression tray
Hollow handles, guide pins, rivets,
Screws
N 12Cr18Ni9 chisels and gouges, bone scraper probes
Hollow handle, guide pin, screw, screw
Caps and Rivets
O 12Cr17Ni7 - Dental Probe Springs, Screws, Rivets
P 06Cr17Ni12Mo2 - - Screws, Rivets
R 90Cr18MoV
Scraper, chisel, tooth curette, drill
Head, tap, countersink
Filler, dental probe, mechanic
Orthodontic pliers
S 68Cr17 Scraper, Chisel, Scraper, Dental Probe -
4 Chemical composition
The chemical composition of stainless steel is shown in Table 2.
Except for the purpose of completing the smelting, the elements not listed in Table 2 shall not be arbitrarily added to the stainless steel without the buyer’s consent. Should take one
Take reasonable measures to prevent the addition of elements from scrap steel or other materials used in the manufacturing process to stainless steel to avoid affecting the stainless steel
Hardenability, mechanical properties and application range.
Table 2 Chemical composition of stainless steel (cast sample analysis)
Code or brand a)
chemical composition/%
Si
Max
Mn
Max
Max
S Cr Mo Ni Other elements
Martensitic stainless steel
0.09~
0.15
1 1 0.04
0.03
Max
11.5~
13.5
- 1
Max
12Cr13
0.08~
0.15
1 1 0.04
0.03
Max
11.5~
13.5
0.6
Max
0.16~
0.25
1 1 0.04
0.03
Max
12~
- 1
Max
20Cr13
0.16~
0.25
1 1 0.04
0.03
Max
12~
0.6
Max
0.26~
0.35
1 1 0.04
0.03
Max
12~
- 1
Max
30Cr13
0.26~
0.35
1 1 0.04
0.03
Max
12~
0.6
Max
32Cr13Mo
0.28~
0.35
0.8 1 0.04
0.03
Max
12~
0.5~
1.0
0.6
Max
0.42~
0.50
1 1 0.04
0.03
Max
12.5~
14.5
Max
40Cr13
0.36~
0.45
0.6 0.8 0.04
0.03
Max
12~
- 0.6
Max
0.47~
0.57
0.5 1 0.03
0.025
Max
13.7~
15.2
0.5
Max
0.60~
0.70
0.5 1 0.03
0.025
Max
12.0~
13.5
- 0.5
Max
0.65~
0.75
1 1 0.04
0.03
Max
12~
0.50
Max
Max
0.35~
0.40
1 1 0.045
0.03
Max
14~
0.4~
0.6
- V. 0.1 to 0.15
0.42~
0.55
1 1 0.045
0.03
Max
12~
0.45~
0.90
- V. 0.1 to 0.15
0.33~
0.43
1 1 0.03
0.03
Max
15~
1.0~
1.5
Max
0.85~
0.95
1 1 0.045
0.03
Max
17~
0.9~
1.3
- V. 0.07~0.12
90Cr18MoV
0.85~
0.95
0.8 0.8 0.04
0.03
Max
17~
1.0~
1.3
0.6
Max
V. 0.07~0.12
0.60~
0.75
1 1 0.04
0.03
Max
16~
0.75
Max
- - -
Table 2 (continued)
Code or brand a)
chemical composition/%
Si
Max
Mn
Max
Max
S Cr Mo Ni Other elements
68Cr17
0.60~
0.75
1 1 0.04
0.03
Max
16~
0.75
Max
0.6
Max
Ferritic stainless steel
0.08
Max
1 1.5 0.06
0.15~
0.35
16~
0.06
Max
Max
Y10Cr17
0.12
Max
1 1.25 0.06 ≥ 0.15
16~
0.06
Max
0.6
Max
10Cr17
0.12
Max
1 1 0.04
0.30
Max
16~
0.06
Max
Austenitic stainless steel
0.07
Max
1 2 0.045
0.03
Max
17~
- 8~
06Cr19Ni10
0.08
Max
1 2 0.045
0.03
Max
18~
8~
0.12
Max
1 2 0.06
0.15~
0.35
17~
- 8~
12Cr18Ni9
0.15
Max
1 2 0.045
0.03
Max
17~
- 8~10
N. 0.10
Max
0.15
Max
1 2 0.045
0.03
Max
16~
- 6~
12Cr17Ni7
0.15
Max
1 2 0.045
0.03
Max
16~
6~
N. 0.10
Max
0.07
Max
1 2 0.045
0.03
Max
16.5~
18.5
2~
2.5
10.5~
13.5
06Cr17Ni12Mo2
0.08
Max
1 2 0.045
0.03
Max
16~
2~
10~14 -
Precipitation hardened stainless steel
05Cr17Ni4Cu4Nb
0.07
Max
1 1 0.04
0.03
Max
15~
17.5
- 3~
Cu. 3~5
Nb. 0.15~0.45
a Manufacturers can choose to add molybdenum up to 0.7%.
6102-
1􀏕 4920
T/