name: sichuan testing center for biomaterials and medical ... · erythocyte micronucleus test yy/t...

ISO/IEC 17025 认可证书

No. CNAS L3940

The scope of the accreditation in Chinese remains the definitive version.

第 1 页共 91 页

Name: Sichuan Testing Center for Biomaterials and Medical Devices

Address: Sichuan University Biomaterials Building, No.29, Wangjiang Road, Chengdu, Sichuan, China

Registration No. CNAS L3940

Accreditation Criteria: ISO/IEC 17025:2017 and relevant requirements of CNAS

Effective Date: 2019-08-01 Expiry Date：2024-04-11

SCHEDULE 3 ACCREDITED TESTING SCOPE

Item/Parameter№ Test Object

№ Item/ ParameterStandard or Method Note

Biological evaluation of medical devices--Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017

Biological evaluation of medical devices--Part 5:Test for in vitro cytotoxicity ISO 10993-5: 2009

Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008

Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005

1 Test for in vitro cytotoxicity

Biological evaluation of medical devices used in dentistry-Part 2:Test method-Cytotoxicity tests:Agar diffusion test and filter diffusion test YY/T 0127.9-2009

Biological evaluation of medical devices - Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010

1 Medical Devices & Materials

2Tests for sensitization(delayed-type hypersensitivity) Test for hypersensitivity of medical devices Part 2:Murine Local Lymph Node

Assay (LLNA):BrdU-ELISA method YY/T 0879.2-2015


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№ Test ObjectItem/Parameter

Standard or Method Note№ Item/ Parameter



Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017



3 Irritation test





4Intracutaneous (intradermal) reactivity test



Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010 5 Oral irritation test

Biological evaluation of medical devices used in dentistry-Part 13:Test method-Oral mucous membrane irritation test YY/T 0127.13-2018


6 Ocular irritation test Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010


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7 Vaginal irritation test Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010


8 Rectal irritation test Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010


9 Penile irritation test Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010

Biological evaluation of medical devices - Part 11:Tests for systemic toxicity GB/T 16886.11-2011

Biological evaluation of medical devices - Part 11:Tests for systemic toxicity ISO 10993-11:2017


10 Acute systemic toxicity test


Biological evaluation of medical devices used in dentistry-Part 2:Test method-Acute oral toxicity test YY/T 0127.14-2009

Biological evaluation of medical devices - Part 11:Tests for systemic toxicity GB/T 16886.11-2011 11

Short term systemic toxicity test: oral route Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

ISO 10993-11:2017

12 Pyrogenicity test Biological evaluation of medical devices - Part 11: Tests for systemic toxicity GB/T 16886.11-2011


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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-11:2017



China pharmacopoeia 2015 1142 Pyrogenicity test China pharmacopoeia 2015


13 Bacterial endotoxin China pharmacopoeia 2015 1143 Pyrogenicity test of endotoxin China pharmacopoeia 2015


14 Sterility testChina pharmacopoeia 2015 1101 Sterility test China pharmacopoeia 2015




Biological evaluation of medical devices used in dentistry Part 15: Test method Subacute and subchronic systemic toxicity test: oral route YY/T 0127.15-2018

15 Subacute systemic toxicity


16 Subchronic systemic toxicity



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Biological evaluation of medical devices used in dentistry-Part 15: Test method- Subacute and subchronic systemic toxicity test: oral route YY/T 0127.15-2018



17 Chronic systemic toxicity Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

ISO 10993-11:2017


Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-11:2017 18 Systemic toxicity:

inhalation routeBiological evaluation of medical devices used in dentistry Part 5:Inhalation toxicity test YY/T 0127.5-2014

Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008

In vitro mammalian chromosome aberration test OECD 473:2016

Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-3:2014

Test for genotoxicity of medical devices-Part 2:In vitro mammalian chromosome aberration test YY/T0870.2-2013

19Mammalian cells chromosome aberration test

Test for genotoxicity of medical devices- Part 5:Mammalian bone marrow chromosome aberration test YY/T 0870.5-2014


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Biological evaluation of medical devices used in dentistry-Part 2: Test method-In Vitro mammalian chromosome aberration test YY/T 0127.16-2009


Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-3:2014 20 Micronucleus test of

bone marrow cellTest for genotoxicity of medical devices- Part 4: Mammalian bone marrow erythocyte micronucleus test YY/T 0870.4-2014


Biological evaluation of medical devices - Part 3: Test for genotoxicity,carcinogenicity and reproductive toxicity ISO 10993-3:2014

In Vitro Mammalian Cell Gene Mutation Test OECD 490：2016

Test for genotoxicity of medical devices-Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells YY/T0870.3-2013

21In Vitro Mammalian Cell Gene Mutation Test

Biological evaluation of medical devices used in dentistry Part 17: Mouse lymphoma cells (TK) gene mutation test YY/T 0127.17-2014


Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-3:2014

Bacterial Reverse Mutation Test OECD 471:1997

Test for genotoxicity of medical devices- Part 1:Bacterial reverse mutation test YY/T0870.1-2013

22Salmonella typhimurium reverse mutation assay

Biological evaluation of medical devices used in dentistry-Part 2:Test method-Salmonella typhimurium reverse mutation assay (Ames mutagenicity test) YY/T 0127.10-2009


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Biological evaluation of medical devices - Part 6: Test for local effects after implantation GB/T 16886.6-2015

Biological evaluation of medical devices - Part 6: Test for local effects after implantation ISO 10993-6:2016


23 Local effects after implantation


24 Subcutaneous implant test

Biological evaluation of dental materials-Part 2:Biological evaluation test method of dental materials-Subcutancous implant test YY/T 0127.8-2001

25 Bone implant test Biological evaluation of dental materials-Part 2:Biological evaluation test method of dental materials-Bone implant test YY/T 0127.4-2009

Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood GB/T 16886.4-2003

Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 26 In vivo thrombosis

testTest methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005


Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 27 In vitro thrombosis

testTest methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005


Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 28 Haemolysis test



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Biological evaluation of dental materials-Unit 1: Haemolysis test YY/T 0127.1-1993


Accredited only for CT,PT,PTT,TT

Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood ISO 10993-4:2017

29 In vitro coagulation relative test



Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 30 Platetet function test



Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 31 Haematology test



Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 32 Complement system

testTest for complement activation of medical devices-Part 1:Serum whole complement activation YY/T0878.1-2013


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Test for complement activation of medical devices-Part 2:Serum alternative pathway complement activation YY/T 0878.2-2015


Biological evaluation of medical devices-Part 13: Identifition and quantification of degradation products from polymeric medical devices GB/T 16886.13-2017

Except for degraded production identification33

Bio-degrade test of polymeric medical devices Biological evaluation of medical devices-Part 13: Identifition and

quantification of degradation products from polymeric medical devices ISO 10993-13:2010

Except for degraded production identification

Biological evaluation of medical devices- Part 14:Identification and quantification of degradation products from ceramics GB/T 16886.14-2003

Accredited only for the extractable components34 Bio-degrade test of

ceramics

Biological evaluation of medical devices- Part 14:Identification and quantification of degradation products from ceramics ISO 10993-14:2001

Accredited only for the extractable components

Biological evaluation of medical devices-Part 20: Principles and methods for immunotoxicology testing of medical devices ISO/TS 10993-20:2006

35

Principles and methods for immunotoxicology testing

Biological evaluation of medical devices-Part 20: Principles and methods for immunotoxicology testing of medical devices GB/T 16886.20-2015


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Tissue engineered medical product-Part 14:Standard Practice for Evaluation of Immune Responsesof Substrate and Scaffolds Products: ELISA Tests YY/T 0606.14-2014

Tissue engineered medical products-Part 15:Standard Practice for Evaluation of Immune Responses of substrate and scaffolds products: Lymphocyte proliferation tests YY/T 0606.15-2014

Tissue engineered medical products-Part 20:Standard Practice for Evaluation of Immune Responses of subatrates and scaffold products: Cell Migration tests. YY/T 0606.20-2014

Biological evaluation of medical devices-Part 9: Framework for identification and quantification of potential degradation products GB/T16886.9-2017

Accredited only for gravimetric analysis

Biological evaluation of medical devices-Part 9: Framework for identification and quantification of potential degradation products ISO 10993-9:2009


Biological evaluation of medical devices - Part 6: Test for local effects after implantation GB/T 16886.6-2015

Biological evaluation of medical devices - Part 6: Test for local effects after implantation ISO 10993-6:2016

Biogical evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric medical devices GB/T 16886.13-2017


36 Test in vivo degradation

Biological evaluation of medical devices-Part 14:Identification and quantificaton of degradation products from ceramics GB/T16886.14-2003



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Biological eveluation of medical devices-Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys GB/T16886.15-2003


Biological evaluation of medical devices- Part 16: Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2013

Biological evaluation of medical devices- Part 15: Identification and quantification of degradation products from metals and alloys GB/T 16886.15-2003

37

Identification and quantification of degradation products from metals and alloys

Biological evaluation of medical devices- Part 15: Identification and quantification of degradation products from metals and alloys ISO 10993-15:2000

Biological evaluation of medical devices- Part 16: Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2013

38

Toxicokinetic study design for degradation products and leachables

Biological evaluation of medical devices- Part 16: Toxicokinetic study design for degradation products and leachables ISO 10993-16:2017

Biological evaluation of medical devices used in dentistry Part 3: Endodontic usage test YY/T 0127.3-2014

39 Endodonic usage test Dentistry - evaluation of biocompatibility of medical devices used in dentistry ISO 7405:2018

Biological evaluation of dental materials-Part 7:Biological evaluation test method of dental materials-Pulp and dentine usage test YY/T 0127.7-2017

40 Pulp and dentine usage test Dentistry - evaluation of biocompatibility of medical devices used in dentistry

ISO 7405:2018

Biological evaluation of medical devices used in dentistry Part 11:pulp capping test YY/T0127.11-2014

41 Pulp capping test Dentistry - evaluation of biocompatibility of medical devices used in dentistry ISO 7405:2018

42 Residues DNA Tissue engineered medical product -Part 25:Quantification of remnant DNA in biological materials utilizing animal tissues and and their derivatives and


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fluorescence method YY/T 0606.25-2014

Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 3407 Detection of exogenous DNA residues by second fluorescence staining

Test for reproductive and developmental toxicity of medical devices Part 1: Screening test YY/T 1292.1-2015

43

Test for reproductive and developmental toxicity of medical devices

Test for reproductive and developmental toxicity of medical devices Part 2: Prenatal developmental toxicity test YY/T 1292.2-2015

44

Biological evaluation of medical devices-Nanamaterial: In vitro cytotoxicity test (MTT assay and LDH assay)

Biological evaluation of medical devices-Nanamaterial: In vitro cytotoxicity test (MTT assay and LDH assay) YY/T 0993-2015

45

Biological evaluation of medical devices-Nanamaterial: Endotoxin test

Biological evaluation of medical devices-Nanamaterial: Endotoxin test YYT1295-2015

46

Immunogenic evaluation method of medical devices - Part 1: T Lymphocyte transformation test in vitro

Immunogenic evaluation method of medical devices - Part 1: T Lymphocyte transformation test in vitro YY/T 1465.1-2016

47

Immunogenic evaluation method of medical devices - Part 2: Serum immunoglobulin and complement

Immunogenic evaluation method of medical devices - Part 2: Serum immunoglobulin and complement component detection Enzyme-linked immunoadsordent assay YY/T 1465.2-2016


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component detection Enzyme-linked immunoadsordent assay

48

Immunogenic evaluation method of medical devices Part 3：Plaque forming cellsassay Agar gel solid-phase method

Immunogenic evaluation method of medical devices Part 3：Plaque forming cellsassay Agar gel solid-phase method YY/T 1465.3-2016

49

Immunogenic evaluation method of medical devices - Part 5: Determination ofα-Gal antigen clearance in medical devices utilizing animal tissues and theirderivatives with M86 antibody

Immunogenic evaluation method of medical devices - Part 5: Determination ofα-Gal antigen clearance in medical devices utilizing animal tissues and theirderivatives with M86 antibody YY/T 1465.5-2016

50

Tissue engineering medical device products - remnant alpha1,3-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives

Tissue engineering medical device products - remnant alpha1,3-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives YY/T 1561-2017

51 Biological evaluation Biological evaluation of medical devices-Nanamaterial: Haemolysis test


No. CNAS L3940


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of medical devices-Nanamaterial: Haemolysis test

YY/T 1532-2017

52

Immunogenic evaluation method of medical devices Part 4： Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes：Ex vivo method

Immunogenic evaluation method of medical devices Part 4： Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes：Ex vivo method YY/T 1465.4-2017

53 In vitro mouse embryo assay

Medical devices for human in vitro assisted reproductive technology ―In vitro mouse embryo assay YY/T 1434-2016

Chinese pharmacopoeia 2015 version Vol Ⅳ General chapters 1105 Microbial limit test for non-sterile products: microbial count

54 microbial limit

Chinese pharmacopoeia 2015 version Vol Ⅳ General chapters 1106 Microbial limit test for non-sterile products: method of controlled bacteria test

2 Hip joint prostheses 1 Part of Parameters Hip joint prostheses YY 0118-2016

Except for fatigue property, total artificial hip abrasion, EO residual, X-ray detection,C,H,O,N,Si,


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Clˉ

2 Hip joint prostheses YY 0118-2016 7.2.1 Except for C,H,O,N

3 Hip joint prostheses YY 0118-2016 7.2.2








11 Hip joint prostheses YY 0118-2016 7.3.1 Except for Clˉ

12 Hip joint prostheses YY 0118-2016 7.4






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18 Hip joint prostheses YY 0118-2016 7.5.2.1

19 Hip joint prostheses YY 0118-2016 7.5.2.2

20 Hip joint prostheses YY 0118-2016 7.5.2.3.2

21 Hip joint prostheses YY 0118-2016 7.5.2.3.3










1 Part of Parameters Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 4-vanadium alloy YY0117.1-2005

Except for C,H,O,N3

Implant for surgery-forgings and castings for bone joint 2 Implant for surgery-forgings and castings for bone joint prosthesis-forgings

with titanium 6-aluminium 4-vanadium alloy YY0117.1-2005 3.1.2Except for C,H,O,N


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Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 4-vanadium alloy YY0117.1-2005 3.4

3 Mechanical properties (tensile strength) Metallic materials - Tensile testing - Part 1 : Method of test at room

temperature GB/T 228.1-2010

4 Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 4-vanadium alloy YY0117.1-2005 3.4






9 Internal quality macrostructure) Microstructure and macrostructure examination for α-β titanium alloys GB/T

5168-2008



11 Internal quality microstructure) Microstructure and macrostructure examination for α-β titanium alloys GB/T

5168-2008

prosthesis-forgings with titanium 6-aluminium 4-vanadium alloy


4

Implant for surgery-forgings and castings for bone joint

1 Part of Parameters Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005

Except for C,H,O,N,internal quality


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2 Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005 3.1

Except for C,H,O,N


Except for C,H,O,N








prosthesis-castings with titanium 6-aluminium 4-vanadium alloy


1 Part of Parameters Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005

Except for C,Si,internal quality

2 Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.1

Except for C,Si


Except for C,Si

5

Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy 4 Implant for surgery-forgings and castings for bone joint prosthesis-castings

cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.4


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Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.4 limitation

7 Mechanical properties (Rockwell hardness) Metallic materials—Rockwell hardness test—Part 1:Test method GB/T 230.1-

2018

8 Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.5.1





1 Part of Parameters Implants for osteosynthesis-Metallic bone plates YY 0017-2016

Except for C,H,O,N，Corrosion resistence fatigue properties

2 Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.1.2


6

Implants for osteosynthesis-Metallic bone plates

4 Hardness Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.2.1


No. CNAS L3940


第 20 页共 91 页



Metallic materials - Vickers hardness test - Part 1: Test method GB/T 4340.1-2009






10 Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.5

1 Part of Parameters Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 Except for C,H,O,N

2 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.1 Except for C,H,O,N

3 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.1 Except for C,H,O,N

4 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.2.1

5 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.3




7

Implants for Osteosyn- thesis-Metallic bone screws

9 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.5


No. CNAS L3940


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1 Part of Parameters Implants for ostesynthesis part 2-Metallic intramedullary nailing YY/T0019.2-2011

Except for C,H,O,N

2 Implants for ostesynthesis part 2-Metallic intramedullary nailing YY/T0019.2-2011 3

Except for C,H,O,N



8

Implants for ostesynthesis part 2-Metallic intramedullary nailing


All Parameters Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite GB23101.2-2008

Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite ISO13779.2-2008 4.1

Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite GB23101.2-2008 4.1

Implants for surgery―Hydroxyapatite―Part 3:Chemical analysis and characterization of crystallinity and phase purity GB 23101.3-2010 10

1

Calcium to phosphorus molar ratio（Chemical analysis）

Implants for surgery―Hydroxyapatite―Part 3:Chemical analysis and characterization of crystallinity and phase purity ISO13779-3:2008 10




2

As,Cd,Hg,Pb(trace elements) and the total amount of heavy metals


9

Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite

3 Crystalline phase compositions



No. CNAS L3940


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Implants for surgery―Hydroxyapatite―Part 4:Determination of coating adhesion strength GB/T 23101.4-2008

4 Coating adhesion strength

Implants for surgery―Hydroxyapatite―Part 4:Determination of coating adhesion strength ISO13779-4:2002

All Parameters Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation ASTM F1088-04a（Reapproved 2010）/YY/T 0683-2008

1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation ASTM F1088-04a（Reapproved 2010） 3.3



10

Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation


11 Ceramics All Parameters Implants for surgery-Hydroxyapatite-Part 1:Ceramics hydroxyapatite


No. CNAS L3940


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GB23101.1-2008/ISO13779-1:2008

1 Implants for surgery-Hydroxyapatite-Part 1:Ceramics hydroxyapatite GB23101.1-2008 4.1.1.1

2 Implants for surgery-Hydroxyapatite-Part 1:Ceramics hydroxyapatite ISO13779-1:2008 4.1.1.1

3 Implants for surgery-Hydroxyapatite-Part 1:Ceramics hydroxyapatite GB23101.1-2008 4.1.1.2

4 Implants for surgery-Hydroxyapatite-Part 1:Ceramics hydroxyapatite ISO13779-1:2008 4.1.1.2

5 Hydroxyapatite Bioactive Ceramics YY 0305-1998 4.1.1.3







hydroxyapatite

12 Hydroxyapatite Bioactive Ceramics YY 0305-1998 4.2

All Parameters Hydroxyapatite Powder YY 0303-1998

1 Hydroxyapatite Powder YY 0303-1998 4.2 12 Hydroxyapatite Powder

2 Particle sizes Hydroxyapatite Powder YY 0303-1998 4.3


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Metallic powders - Determination of particle size by dry sieving GB/T 1480-2012

Hydroxyapatite Powder YY 0303-1998 4.4 3 Hydroxyapatite

content Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0451 X-ray diffraction

Hydroxyapatite Powder YY 0303-1998 4.5

Phosphate rock and concentrate--Determination of calcium oxide content--Volumetric methods GB/T 1871.4-1995 4

Calcium to phosphorus molar ratio Phosphate rock and concentrate--Determination of phosphrous pentoxide

content--Quinoline phosphomolybdate gravimetric and volumetric methods GB/T 1871.1-1995

5 Hydroxyapatite Powder YY 0303-1998 4.6

Hydroxyapatite Powder YY 0303-1998 4.7

Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0821 Heavy metal inspection

6

As,Cd,Hg,Pb(trace elements) and the total amount of heavy metals Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0822 Arsenic

salt test

All Parameters Standard Specification for Composition of Anorganic Bone for Surgical Implants ASTM F1581-2008

1 Standard Specification for Composition of Anorganic Bone for Surgical Implants ASTM F1581-2008 4.1


13

Standard Specification for Composition of Anorganic Bone for Surgical Implants 3 Standard Specification for Composition of Anorganic Bone for Surgical

Implants ASTM F1581-2008 4.3


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All Parameters Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003

1 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 4.1






7 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 5.1.1

14

Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation



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16 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 6

All Parameters General specification for surgical implants made of silicone elastomer YY0334-2002

1 General specification for surgical implants made of silicone elastomer YY0334-2002 4

2 General specification for surgical implants made of silicone elastomer YY0334-2002 5.2

3 General specification for surgical implants made of silicone elastomer YY0334-2002 5.3.1



15 silicone elastomer



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11 General specification for surgical implants made of silicone elastomer YY0334-2002 6

All Parameters General technique requirements for orthopaedics clamp(scissor) YY 1122-2005

1 General technique requirements for orthopaedics clamp(scissor) YY 1122-2005 4.1



16 orthopaedics clamp(scissor)


All Parameters General technique requirements for orthopaedics saw YY 1137-2005

1 General technique requirements for orthopaedics saw YY 1137-2005 4.1



17 orthopaedics saw



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All Parameters Medical forceps YY/T0686-2008

1 Medical forceps YY/T0686-2008 4.1






18 Medical forceps


All Parameters General technique requirements for orthopedic chisel YY/T 91141-1999

1 General technique requirements for orthopedic chisel YY/T 91141-1999 1.1



19

General technique requirements for orthopedic chisel



No. CNAS L3940


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Part of Parameters Peritoneal dialysis tube YY 0030-2004

Except for radiation detectability

1 Peritoneal dialysis tube YY 0030-2004 5.1







20 Peritoneal dialysis tube



No. CNAS L3940


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9 Peritoneal dialysis tube YY 0030-2004 6

10 Peritoneal dialysis tube YY 0030-2004 7

All Parameters Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008

1 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.1

Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.2

2 Shore hardness Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1：Duromerer method （Shore hardness） GB/T 531.1-2008




Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.2

6 Tear strength Rubber,vulcanized or thermoplastic - Determination of tear strength（Trouser，angle and crescent test pieces） GB/T 529-2008




21

Silicone tubes and elastomeric parts for infusion and transfusion



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11 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.3.2

12 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.3.3








All Parameters U.S. Food and Drug Administration (FDA) [Web site]. InFUSEBone Graft/LT-CAGELumbar Tapered Fusion Devices FDA P000058

22

InFUSEBone Graft/LT-CAGELumbar Tapered Fusion Devices

1 U.S. Food and Drug Administration (FDA) [Web site]. InFUSEBone Graft/LT-CAGELumbar Tapered Fusion Devices FDA P000058 4

1 Part of Parameters Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6

Except for the struction analysis23 type Ⅰcollagen

2 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.1


No. CNAS L3940


第 32 页共 91 页















All Parameters Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 24 chitosan

1 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.1


No. CNAS L3940


第 33 页共 91 页















25 alginate 1 Part of Parameters Tissue engineered medical products part 8: alginate YY/T 0606.8-2008

Except for NMR,The average molecular weight and molecular


No. CNAS L3940


第 34 页共 91 页



weight distribution,Microbial Limit

2 Tissue engineered medical products part 8: alginate YY/T 0606.8-2008 4.1








Tissue engineered medical products part 8: alginate YY/T 0606.8-2008 4.10


10 microbial limit


All Parameters Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9－2007

26 sodium hyaluronate

1 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9－2007 5.1


No. CNAS L3940


第 35 页共 91 页


















No. CNAS L3940


第 36 页共 91 页




All Parameters Wrought titanium and titanium dental implant YY 0315-2016Except for Fatigue Limit

1 Wrought titanium and titanium dental implant YY 0315-2016 5.1


3 Wrought titanium and titanium dental implant YY 0315-2016 5.3.1

4 Wrought titanium and titanium dental implant YY 0315-2016 5.3.2.1




Wrought titanium and titanium dental implant YY 0315-2016 5.4.2 8 Surface defect

Liquid penetrant inspection of metallic surgical implants YY/T 0343-2002




27

Wrought titanium and titanium dental implant



No. CNAS L3940


第 37 页共 91 页




Wrought titanium and titanium dental implant YY 0315-2016 5.6.3 14 Fatigue limit Dentistry-Implants-Dynamic fatigue test for endosseous dental implants YY/T

0521-2018



All Parameters Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009Except for Fatigue limit

1 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.2.1







8 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.3.2.1.1

28

Plasma sprayed hydroxyapatite coated titanium dental implant



No. CNAS L3940


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11 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.3.2.2


13 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.4

Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.3.4

14 Dynamic fatigue test Dentistry-Implants-Dynamic fatigue test for endosseous dental implants YY/T 0521-2018

15 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.5

All Parameters Dentistry-polymer-based crown and bridge materials YY 0710-2009

1 Dentistry-polymer-based crown and bridge materials YY 0710-2009 5.1

2 Dentistry-polymer-based crown and bridge materials ISO 10477:2004 5.1





29polymer-based crown and bridge materials



No. CNAS L3940


第 39 页共 91 页
















part of Parameters Dentistry-Artificial teeth for dental prostheses YY 0300-2009Except for radioactivity30

Artificial teeth for dental prostheses 1 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.1.1


No. CNAS L3940


第 40 页共 91 页



2 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.1.2










1 All of Parameters Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011

Except for Maximum flexural strength and Total work of fracture

2 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.1.1

31 Denture base polymers



No. CNAS L3940


第 41 页共 91 页













14 Maximum stress intensity factor

Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.10


16 Total fracture work Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.11




No. CNAS L3940


第 42 页共 91 页



1 All of Parameters Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011

Except for Maximum flexural strength and Total work of fracture

2 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.1.1










32 Orthodontic base polymers

12 Maximum stress intensity factor

Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.8


No. CNAS L3940


第 43 页共 91 页




14 Total fracture work Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.2-2011 5.2.9



Part of Parameters Dental root canal sealing materials YY 0717-2009Except for Microbial hazard

1 Dental root canal sealing materials YY 0717-2009 4.1

2 Dental root canal sealing materials YY 0717-2009 4.2

3 Dental root canal sealing materials YY 0717-2009 4.3.1






33Dental root canal sealing materials


34 Casting gold alloys Part of Parameters Dentistry-Casting gold alloys YY 0620-2008

Except for Melting range,


No. CNAS L3940


第 44 页共 91 页



electrochemical properties

1 Dentistry-Casting gold alloys YY 0620-2008 5.1








Part of Parameters Matal-ceramic dental restorative systems YY 0621-2008

Exept for Solidus and liquidus temperature

1 Matal-ceramic dental restorative systems YY 0621-2008 4.1.1

2 Matal-ceramic dental restorative systems YY 0621-2008 4.2

35

Mental-ceramic dental restorative systems



No. CNAS L3940


第 45 页共 91 页







All Parameters Matal-ceramic dental restorative systems YY 0621-2008

1 Matal-ceramic dental restorative systems YY 0621-2008 4.1.2.1

2 Matal-ceramic dental restorative systems YY 0621-2008 4.1.2.2

3 Matal-ceramic dental restorative systems YY 0621-2008 4.2





36



Part of Parameters Dental-Ceramic YY 0716-2009Except for radioactivity37 Dental-Ceramic

1 Dental-Ceramic YY 0716-2009 5.1


No. CNAS L3940


第 46 页共 91 页



2 Dental-Ceramic YY 0716-2009 5.2.1







All Parameters Elastomeric impression materials YY0493-2011

1 Elastomeric impression materials YY0493-2011 6.1







38Elastomeric impression materials



No. CNAS L3940


第 47 页共 91 页




All Parameters Dental alginate impression materials YY1027-2001

1 Dental alginate impression materials YY1027-2001 4.2








39Dental alginate impression materials


1 Part ofParameters Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016

2 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 5.2.1


4 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 5.3

40Powder/liquid acid-base cements



No. CNAS L3940


第 48 页共 91 页









All Parameters Dental water-based cements-Part 2:Resin-modified cements YY0271.2-2016

1 Dental water-based cements-Part 2:Resin-modified cements YY0271.2-2016 5.1






41 Resin-modified cements


42

Zinc oxide/eugenol All Parameters Dentistry-Zinc oxide/eugenol and zinc oxide/non-eugenol cements YY 0272-

2009


No. CNAS L3940


第 49 页共 91 页



1 Dentistry-Zinc oxide/eugenol and zinc oxide/non-eugenol cements YY 0272-2009 4.1





and zinc oxide/non-eugenol cements


All Parameters Dental prefabricated root post YY/T 0517-2009

1 Dental prefabricated root post YY/T 0517-2009 5.1






43Dental prefabricated root post


All Parameters Dentistry-Polymer-based restorative materials YY 1042-2011 44

Polymer-based restorative materials 1 Dentistry-Polymer-based restorative materials YY 1042-2011 5.2.2


No. CNAS L3940


第 50 页共 91 页



2 Dentistry-Polymer-based restorative materials YY 1042-2011 5.2.3








10 Dentistry-Polymer-based restorative materials YY 1042-2011 5.3



All Parameters Dental-Orthodontic bracket adhesive materials YY/T 0269-2009

1 Dental-Orthodontic bracket adhesive materials YY/T 0269-2009 4.1



45Orthodontic bracket adhesive materials



No. CNAS L3940


第 51 页共 91 页





All Parameters Dental pluggers YY/T 0275-2011

1 Dental pluggers YY/T 0275-2011 4.1






46 Dental pluggers


All Parameters Dental gypsum products YY 0462-2003

1 Dental gypsum products YY 0462-2003 4.1




47 Dental gypsum products



No. CNAS L3940


第 52 页共 91 页





All Parameters Dentistry - Casting investments and refractory die materials YY/T 0463-2011

1 Dentistry - Casting investments and refractory die materials YY/T 0463-2011 5.2






48

Casting investments and refractory die materials


All Parameters Dental aqueous impression materials based on agar YY 0494-2004

1 Dental aqueous impression materials based on agar YY 0494-2004 5.1



49

Dental aqueous impression materials based on agar



No. CNAS L3940


第 53 页共 91 页










All Parameters Dental root-canal obturating points YY 0495-2009

1 Dental root-canal obturating points YY 0495-2009 4.1






50Dental root-canal obturating points


51 Titanium and titanium alloy 1 All Parameters Titanium and titanium alloy dental implant attachments YY/T 0520-2009 Except for

Fatigue


No. CNAS L3940


第 54 页共 91 页



limitation

2 Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.1







Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.6 9 Fatigue limit Dentistry-Implants-Dynamic fatigue test for endosseous dental implants YY/T

0521-2018


dental implant attachments


Part of Parameters Mental-ceramic dental restorative systems YY 0621-2008

Except for liquidus and solidus temperature

52


1 Mental-ceramic dental restorative systems YY 0621-2008 4.1.1


No. CNAS L3940


第 55 页共 91 页



2 Mental-ceramic dental restorative systems YY 0621-2008 4.1.2.1

3 Mental-ceramic dental restorative systems YY 0621-2008 4.1.2.2

4 Mental-ceramic dental restorative systems YY 0621-2008 4.2










All Parameters Dental resin-based pit and fissure sealants YY 0622-2008

1 Dental resin-based pit and fissure sealants YY 0622-2008 4.2

2 Dental resin-based pit and fissure sealants YY 0622-2008 4.3 53

Dental resin-based pit and fissure sealants

3 Dental resin-based pit and fissure sealants YY 0622-2008 4.4.1


No. CNAS L3940


第 56 页共 91 页









54

Test method of soluble fluoride of dental materials

All Parameters Test method of soluble fluoride of dental materials YY 0623-2008

All Parameters Dentistry-Orthodontic products-Orthodontic elastomeric auxiliaries YY/T 0624-2016

1 Dentistry-Orthodontic products-Orthodontic elastomeric auxiliaries YY/T 0624-2016 4.2

2 Dentistry-Orthodontic products-Orthodontic elastomeric auxiliaries YY/T 0624-2016 4.3.1


55

Dentistry-Orthodontic products-Orthodontic elastomeric auxiliaries


All Parameters Dentistry-Orthodontic products: Wires YY/T 0625-2016 56

Dentistry-Orthodontic products: Wires 1 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.2


No. CNAS L3940


第 57 页共 91 页



2 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.3

3 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.4.1






9 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.5

Part of Parameters Dental casting alloys with noble metal content of at least 25% but less than 75% YY 0626-2008

Except for Melting range

1 Dental casting alloys with noble metal content of at least 25% but less than 75% YY 0626-2008 4.1





57

Dental casting alloys with noble metal content of at least 25% but less than 75%



No. CNAS L3940


第 58 页共 91 页





58

Dental bleach materials-Test method of perioxide component

All Parameters Dental bleach materials-Test method of perioxide component YY/T 0632-2008

All Parameters Root-canal lubricating &cleaning agent with EDTA YY/T 0516-2009

1 Root-canal lubricating &cleaning agent with EDTA YY/T 0516-2009 4.1




59

Root-canal lubricating &cleaning agent with EDTA


All Parameters Dental polymer based adhesives for restoratives YY/T 0518-2009

1 Dental polymer based adhesives for restoratives YY/T 0518-2009 4.1



60Dental polymer based adhesives for restoratives



No. CNAS L3940


第 59 页共 91 页






All Parameters Phosphoric etching gel YY 0769-2009

1 Phosphoric etching gel YY 0769-2009 3.1

2 Phosphoric etching gel YY 0769-2009 3.2 61 Phosphoric

etching gel

3 Phosphoric etching gel YY 0769-2009 3.3

1 Part of Parameters Medical sodium hyaluronate gel YY/T 0308-2015

Except for Shear Viscosity, Flexibility,Refractive index

Medical sodium hyaluronate gel YY/T 0308-2015 5.1 2 Appearance Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0904 Visible

foreign body inspection

3 Medical sodium hyaluronate gel YY/T 0308-2015 5.2



62 Medical sodium hyaluronate gel

6 Transmittance Medical sodium hyaluronate gel YY/T 0308-2015 5.5


No. CNAS L3940


第 60 页共 91 页



Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0401 Ultraviolet-visible spectrophotometry

Medical sodium hyaluronate gel YY/T 0308-2015 5.6 7 pH value Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0631 pH

measurement

Medical sodium hyaluronate gel YY/T 0308-2015 5.7 8 Osmotic pressure Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0632 method

of osmolality determination

9 Shear viscosity Medical sodium hyaluronate gel YY/T 0308-2015 5.8

10 Elasticity Medical sodium hyaluronate gel YY/T 0308-2015 5.9

Medical sodium hyaluronate gel YY/T 0308-2015 5.10.1 11 Intrinsic viscosity

(molecular weight) Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0633 Viscosity measurement



Medical sodium hyaluronate gel YY/T 0308-2015 5.14 14 Heavy metal content Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0821 Heavy

metal inspection

Medical sodium hyaluronate gel YY/T 0308-2015 5.15 15 Ethanol residue Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0861

Residual solvent assay


No. CNAS L3940


第 61 页共 91 页







All Parameters Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1:General requirements YY/T 0466.1-2016

1 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1:General requirements YY/T 0466.1-2016 4.1

63

Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1:General requirements

2 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1:General requirements YY/T 0466.1-2016 4.2

All Parameters Dentistry-Polymer-based die materials YY/T0911-2014

1 Dentistry-Polymer-based die materials YY/T0911-2014 4.1





64Dentistry-Polymer-based die materials



No. CNAS L3940


第 62 页共 91 页



All Parameters Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014

1 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.1











Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.12

Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0521 Gas chromatography

65

Cross-linked sodium hyaluronate gel for plastic Surgery

12 The residual amount of crosslinking agent

Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0405 Fluorescence spectrophotometry


No. CNAS L3940


第 63 页共 91 页









All Parameters Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014

1 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 4.1

2 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 4.2

3 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 a）

4 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 b）

5 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 c）

Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 d）

66

Implants for Surgery Bioglass and glass ceramic biomaterials

6 Hardness Fine ceramics（advanced ceramics,advanced technical ceramics）- Test method for hardness of monolithic ceramics at room temperature GB/T 16534-2009


No. CNAS L3940


第 64 页共 91 页



7 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 e）

8 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 f）

9 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 g）

Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 h）

10 Thermal expansion coefficient Fine ceramics (advanced ceramics, advanced technical ceramics) - Test

method for linear thermal expansion of monolithic ceramics by push-rod technique GB/T 16535-2008

11 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 i）

12 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 6

All Parameters Dental temporary polymer-based crown and bridge materials YY/T 0826-2011

1 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.1





67

Dental temporary polymer-based crown and bridge materials



No. CNAS L3940


第 65 页共 91 页








All Parameters Implants for Surgery -Acrylic resin cements YY 0459-2003

1 Implants for Surgery -Acrylic resin cements YY 0459-2003 3.1





6 Implants for Surgery -Acrylic resin cements YY 0459-2003 5




68Implants for Surgery -Acrylic resin cements



No. CNAS L3940


第 66 页共 91 页









1 Part of Parameters Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013

Except for solidus and liquidus temperature or melting point

2 Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.1



5 Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.4.2


69

Dentistry-Metallic materials for fixed and romovable restorations and appliances



No. CNAS L3940


第 67 页共 91 页



Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.5

8 Density Method of measurement of density for precious metals and their alloys GB/T 1423-1996

Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.6

9 Corrosion resistanceChinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0411 Inductively Coupled Plasma Atomic Emission Spectrometry



1 Part of Parameters Dentistry-Ceramic materials GB 30367-2013Except for radioactivity

2 Dentistry-Ceramic materials GB 30367-2013 5.1

3 Dentistry-Ceramic materials GB 30367-2013 5.2.1

4 Dentistry-Ceramic materials GB 30367-2013 5.2.3





70Dentistry-Ceramic materials



No. CNAS L3940


第 68 页共 91 页




All Parameters Dentistry-Soft lining materials for removable dentures-Part1:Materials for short-term use YY 0714.1-2009

1 Dentistry-Soft lining materials for removable dentures-Part1:Materials for short-term use YY 0714.1-2009 5.1 71

Dentistry-Soft lining materials for removable dentures-Part1:Materials for short-term use

2 Dentistry-Soft lining materials for removable dentures-Part1:Materials for short-term use YY 0714.1-2009 5.2

All Parameters Dentistry-Soft lining materials for removable dentures-Part2:Materials for long-term use YY 0714.2-2016

1 Dentistry-Soft lining materials for removable dentures-Part2:Materials for long-term use YY 0714.2-2016 5.1 72

Dentistry-Soft lining materials for removable dentures-Part2:Materials for long-term use

2 Dentistry-Soft lining materials for removable dentures-Part2:Materials for long-term use YY 0714.2-2016 5.2

1 Part of Parameters Medical carboxymethylchitosan YY 0953-2015

Except for Weight-average molecular weight and molecular weight distribution,and microbial limit

Medical carboxymethylchitosan YY 0953-2015 5.1

73Medical carboxymethylchitosan

2 Appearance Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0904 Visible foreign body inspection


No. CNAS L3940


第 69 页共 91 页



Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0901 Solution color inspection

Medical carboxymethylchitosan YY 0953-2015 5.2 3 Qualitative test

(identification test) Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0402 Infrared spectrophotometry

4 Medical carboxymethylchitosan YY 0953-2015 5.3


Medical carboxymethylchitosan YY 0953-2015 5.5 6 Loss on drying Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0831

Determination of drying weightlessness




Medical carboxymethylchitosan YY 0953-2015 5.10 10 Carboxymethyl

chitosan purity Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0704 Nitrogen assay


Medical carboxymethylchitosan YY 0953-2015 5.12.1 12 Heavy metal content Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0821 Heavy

metal inspection


No. CNAS L3940


第 70 页共 91 页



13 Medical carboxymethylchitosan YY 0953-2015 5.12.2

Medical carboxymethylchitosan YY 0953-2015 5.13 14 Residue on ignition Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0841

Inspection method for residue on ignition


Medical carboxymethylchitosan YY 0953-2015 5.15.1 16 Ethanol residue Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0521 Gas

chromatography





Medical carboxymethylchitosan YY 0953-2015 5.16.2


21 microbial limit



74Nonactive surgical implas-Type I collagen

1 Part of Parameters Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015

Except for Acid hydrolyzat


No. CNAS L3940


第 71 页共 91 页



e, collagen content (amino acid analyzer method)

2 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.2.2

Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.2.3

3 LoadingChinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0942 Minimum loading inspection



Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.3

6 Hybrid protein analysis Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0541

Electrophoresis



9 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.6.1

Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.6.2

implants-Specific requirements

10As,Cd,Hg,Pb,Cr,Cu,Fe,Ni,Mo(trace elements) Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0406

Atomic absorption spectrophotometry


No. CNAS L3940


第 72 页共 91 页



Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0411 Inductively Coupled Plasma Atomic Emission Spectrometry






1 Part of Parameters Medical instruments of stainless steel-Test methods of corrosion resistance YY/T 0149-2006

Except for Pressure steam method

2 Medical instruments of stainless steel-Test methods of corrosion resistance YY/T 0149-2006 5




75

Medical instruments of stainless steel-Test methods of corrosion resistance


All Parameters Test method for primary wound dressing-Part1: Aspects of absorbency YY/T 0471.1-2004

76

Test method for primary wound dressing-Part1: Aspects of 1 Test method for primary wound dressing-Part1: Aspects of absorbency YY/T

0471.1-2004 3.2


No. CNAS L3940


第 73 页共 91 页



2 Test method for primary wound dressing-Part1: Aspects of absorbency YY/T 0471.1-2004 3.3




absorbency


All Parameters Test method for primary wound dressing-Part2:Moisture vapour transmission rate of permeable film dressings YY/T 0471.2-2004

1 Test method for primary wound dressing-Part2:Moisture vapour transmission rate of permeable film dressings YY/T 0471.2-2004 3.2

77

Test method for primary wound dressing-Part2:Moisture vapour transmission rate of permeable film dressings

2 Test method for primary wound dressing-Part2:Moisture vapour transmission rate of permeable film dressings YY/T 0471.2-2004 3.3

All Parameters Test method for primary wound dressing-Part3:Waterproofness YY/T 0471.3-2004

78

Test method for primary wound dressing-Part3:Waterproofness

1 Test method for primary wound dressing-Part3:Waterproofness YY/T 0471.3-2004 3.2

All Parameters Test method for primary wound dressing-Part4:Conformability YY/T 0471.4-2004

79

Test method for primary wound dressing-Part4:Conformability

1 Test method for primary wound dressing-Part4:Conformability YY/T 0471.4-2004 3.2

80

Test method for primary wound All Parameters Test method for primary wound dressing-Part5:Bacterial barrier properties

YY/T 0471.5-2017


No. CNAS L3940


第 74 页共 91 页



1Bacterial barrier properties(Low moisture condition)

Test method for primary wound dressing-Part5:Bacterial barrier properties YY/T 0471.5-2017 5

2

Bacterial barrier properties(semi wet condition)( External dry


3

Bacterial barrier properties(semi wet condition) ( External wet)


dressing-Part5:Bacterial barrier properties

4Bacterial barrier properties(Wet condition)


All Parameters Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004

1 Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004 5.1

Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004 5.2

2 Intrinsic viscosity Plastics - Determination of the viscosity of polymers in dilute solution using capillary viscometers - Part1:General principles GB/T 1632.1-2008

Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004 6

3 Tensile Strength Plastics - Determination of tensile properties - Part 1: General principles GB/T 1040.1-2018

4 Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004 6

81

Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing

5 Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004 6


No. CNAS L3940


第 75 页共 91 页



All Parameters Dental materials Testing of adhesion to tooth structure YY/T 0519-2009

1 Dental materials Testing of adhesion to tooth structure YY/T 0519-2009 5.2

2 Dental materials Testing of adhesion to tooth structure YY/T 0519-2009 5.3 82

Dental materials Testing of adhesion to tooth structure

3 Dental materials Testing of adhesion to tooth structure YY/T 0519-2009 5.4

83

Dental materials-Determination of colour stability

All Parameters Dental materials-Determination of colour stability YY/T 0631-2008

1 Part of Parameters Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008

Except for notched impact strength

2 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.1






84

Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications



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Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.4

13 Bending strengthPlastics - Determination of flexural properties GB/T 9341-2008


1 Part of Parameters Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008

Except for average molecular weight and molecular weight distribution,HNMR

2 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.1


4 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.3.1

85

Standard specification for virgin poly(L-lactic acid) resin for surgical implants



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86

Test methods for boning properties of tissue adhesives-Part1: Strength in lap-shear by tension loading

All Parameters Test methods for boning properties of tissue adhesives-Part1: Strength in lap-shear by tension loading YY/T 0729.1-2009

87

Test methods for boning properties of tissue adhesives-Part2: Strength in T-peel by tension loading

All Parameters Test methods for boning properties of tissue adhesives-Part2: Strength in T-peel by tension loading YY/T 0729.2-2009

88

Test methods for boning properties of tissue adhesives-

All Parameters Test methods for boning properties of tissue adhesives-Part3:Tension strength YY/T 0729.3-2009


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Part3:Tension strength

89

Test methods for boning properties of tissue adhesives-Part4: Wound closure strength

All Parameters Test methods for boning properties of tissue adhesives-Part4: Wound closure strength YY/T 0729.4-2009

All Parameters Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011

1 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.1.1





6 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.2




90

Dental calcium hydroxide pulp capping and lining materials



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All Parameters Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015

1 Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015 4.1

2 Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015 4.2.1







91

Dentistry-Brackets and tubes for use in orthodontics


1 Part of Parameters Dentistry-Denture adhesives YY/T 1280-2015Except for microbial index

2 Dentistry-Denture adhesives YY/T 1280-2015 5.1.1



92Dentistry-Denture adhesives



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1 Part of Parameters GB/T 14233.1-2008 Except for EO residue

GB/T 14233.1-2008 5.1 2 Turbidity and color Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0901

Solution color inspection， 0902 Clarity inspection

3 GB/T 14233.1-2008 5.2

GB/T 14233.1-2008 5.3 4 Chloride Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0801

Chloride inspection

5 GB/T 14233.1-2008 5.4

6 GB/T 14233.1-2008 5.5

7 GB/T 14233.1-2008 5.6

93

Medical transfusion, infusion and injection apparatus part1： chemical analysis methods

8 GB/T 14233.1-2008 5.7


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9 GB/T 14233.1-2008 5.8

10 GB/T 14233.1-2008 5.9

11 GB/T 14233.1-2008 6

12 GB/T 14233.1-2008 7

13 GB/T 14233.1-2008 8

1 Part of Parameters YY/T 1453-2016

Exept for peptide map,acid hydrolyzate,fat content, do not use the amino acid analyzer to determine the collagen content

2 YY/T 1453-2016 4.1

3 YY/T 1453-2016 4.2

4 YY/T 1453-2016 4.3 Limitation

94 Type I collagen

5 YY/T 1453-2016 4.4


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6 YY/T 1453-2016 4.6

7 YY/T 1453-2016 4.7

YY/T 1453-2016 4.8

Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 2321 Lead, cadmium, arsenic, mercury, copper determination

8

As,Cd,Hg,Pb,Cr,Cu,Fe,Ni,Mo(trace elements) and the total amount of heavy metals Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0411

Inductively Coupled Plasma Atomic Emission Spectrometry

9 YY/T 1453-2016 4.10

10 YY/T 1453-2016 4.12

All Parameters Dentistry-Compatibility testing-Part1：Metal-ceramic systems YY 0621.1-2016

1 Dentistry-Compatibility testing-Part1：Metal-ceramic systems YY 0621.1-2016 6.1.1

2 Dentistry-Compatibility testing-Part1：Metal-ceramic systems YY 0621.1-2016 6.1.2

3 Dentistry-Compatibility testing-Part1：Metal-ceramic systems YY 0621.1-2016 6.2


95 Metal-ceramic systems


All Parameters Implant for surgery-Skeletal pins and wires-Part1：Material and mechanical requirems YY/T 0345.1-2011

96 skeletal pins and wires

1 Implant for surgery-Skeletal pins and wires-Part1：Material and mechanical


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requirems YY/T 0345.1-2011 3

2 Implant for surgery-Skeletal pins and wires-Part1：Material and mechanical requirems YY/T 0345.1-2011 4



5 Implant for surgery-Skeletal pins and wires-Part2：Steinmann skeletal pins-Dimensions YY/T 0345.2-2014 2

6 Implant for surgery-Skeletal pins and wires-Part2：Steinmann skeletal pins-Dimensions YY/T 0345.2-2014 3

7 Implant for surgery-Skeletal pins and wires-Part3：kirschner skeletal wires YY/T 0345.3-2014 3

8 Implant for surgery-Skeletal pins and wires-Part3：kirschner skeletal wires YY/T 0345.3-2014 4

All Parameters Corneal cell carrier membrane STCBM/FB-001-2017

1 Appearance Corneal cell carrier membrane STCBM/FB-001-2017 4.1

2 Dimension Corneal cell carrier membrane STCBM/FB-001-2017 4.2

3 Transmittance Corneal cell carrier membrane STCBM/FB-001-2017 4.3

4 Water content Corneal cell carrier membrane STCBM/FB-001-2017 4.4

5 pH value Corneal cell carrier membrane STCBM/FB-001-2017 4.5

97Corneal cell carrier membrane

6 Heavy metal content Corneal cell carrier membrane STCBM/FB-001-2017 4.6


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7 Content Corneal cell carrier membrane STCBM/FB-001-2017 4.7

All Parameters Soft tissue repair patch STCBM/FB-002-2017

1 Dimension Soft tissue repair patch STCBM/FB-002-2017 5.1

2 Appearance Soft tissue repair patch STCBM/FB-002-2017 5.2

3 Tensile Strength Soft tissue repair patch STCBM/FB-002-2017 5.3.1

4 Elongation at break Soft tissue repair patch STCBM/FB-002-2017 5.3.2

5 Peracetic acid residual Soft tissue repair patch STCBM/FB-002-2017 5.4.1

6 Ethanol residue Soft tissue repair patch STCBM/FB-002-2017 5.4.2

7 pH value Soft tissue repair patch STCBM/FB-002-2017 5.4.3

98 Soft tissue repair patch

8 Heavy metal content Soft tissue repair patch STCBM/FB-002-2017 5.4.4

All Parameters Customised activity denture STCBM/FB-005-2017

1 Design Customised activity denture STCBM/FB-005-2017 4.1

2 Raw materials Customised activity denture STCBM/FB-005-2017 4.2

3 Polished surface Customised activity denture STCBM/FB-005-2017 4.3

4 Tissue surface Customised activity denture STCBM/FB-005-2017 4.4

99 Customised activity denture

5 Denture base Customised activity denture STCBM/FB-005-2017 4.5


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6 Colour Customised activity denture STCBM/FB-005-2017 4.6

7 Color stability Customised activity denture STCBM/FB-005-2017 4.7

8 Partial denture metal part internal mass Customised activity denture STCBM/FB-005-2017 4.8

9 Partial denture Customised activity denture STCBM/FB-005-2017 4.9

10 Full denture occlusion Customised activity denture STCBM/FB-005-2017 4.10

11 Full denture thickness Customised activity denture STCBM/FB-005-2017 4.11

All Parameters Custom fixed denture STCBM/FB-004-2017

1 Design Custom fixed denture STCBM/FB-004-2017 4.1

2 Raw materials Custom fixed denture STCBM/FB-004-2017 4.2

3 Colour Custom fixed denture STCBM/FB-004-2017 4.3

4 Appearance and surface roughness Custom fixed denture STCBM/FB-004-2017 4.4

5 Metal ceramic bonding properties Custom fixed denture STCBM/FB-004-2017 4.5

6Hot and cold-resistant performance of emergency

Custom fixed denture STCBM/FB-004-2017 4.6

7 Metal internal quality Custom fixed denture STCBM/FB-004-2017 4.7

100 Custom fixed denture

8 Porosity Custom fixed denture STCBM/FB-004-2017 4.8


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9 Adjacency Custom fixed denture STCBM/FB-004-2017 4.9

10 Adhesion Custom fixed denture STCBM/FB-004-2017 4.10

11 Occlusal Custom fixed denture STCBM/FB-004-2017 4.11

12 Denture morphology Custom fixed denture STCBM/FB-004-2017 4.12

1 All Parameters Custom orthodontic appliances / retainers STCBM/ FB-003-2017

2 Design Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.1

3 Appearance and structure Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.2

4 Hardness Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.3

5 Corrosion resistance Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.4

6 Surface roughness Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.5

7 Raw materials Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.6

8 Arch wire Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.7

101

Custom orthodontic appliances / retainers

9 Color stability Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.8

1 All Parameters Zirconia ceramics STCBM/FB-006-2017

2 Dimension Zirconia ceramics STCBM/FB-006-2017 4.1 102 Zirconia ceramics

3 Appearance Zirconia ceramics STCBM/FB-006-2017 4.2


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4 Pre-sintering density Zirconia ceramics STCBM/FB-006-2017 4.3

5 Sintering density Zirconia ceramics STCBM/FB-006-2017 4.4

6 Flexural strength Zirconia ceramics STCBM/FB-006-2017 4.5

7 Chemical solubility Zirconia ceramics STCBM/FB-006-2017 4.6

8 Product composition Zirconia ceramics STCBM/FB-006-2017 4.7

1 All Parameters Dentistry-Casting and Baseplate waxes YY/T 0496-2016

2 Dentistry-Casting and Baseplate waxes YY/T 0496-2016 5.1









103Dentistry-Casting and Baseplate waxes



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1 Compressive properties Plastics - Detemination of compressive properties GB/T 1041-2008

2 Specific optical rotation

Chemical reagent - General method for the determination of specific optical rotatory power（specific optical rotation） GB/T 613-2007

3 Density and apparent porostiy

Test methods for density and apparent porostiy of fine ceramics GB/T 25995-2010

4 Apparent porosity and bulk density

Test method for apparent porosity and bulk density of porous ceramic GB/T 1966-1996

5 Crystallite size and micro-strain

Determination of crystallite size and micro-strain of nano-materials - X-ray diffraction line broadening method GB/T 23413-2009

6 Static immersion test Dentistry—Corrosion test methods for metallic materials YY/T 0528-2018 4.1

7 Sulfide tarnish test（cyclic immersion）

Dentistry—Corrosion test methods for metallic materials YY/T 0528-2018 4.3

8 Sulfide tarnish test（static immersion）


104 Medical Devices & Materials

9 Static immersion test with periodic analysis


1 Part of ParametersDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019

except for Solidus and liquidus temperatures or melting points

105

Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances 2

Chemical composition and Harmful ingredients

Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.1.1


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3 Powder appearanceDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.1.2

4 RoundnessDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.1.3


5 Powder size and

distributionParticle size analysis—Laser diffraction methods GB/T 19077-2016


6 Flow time

Metallic powders-Determination of flow time by means of 啊 calibrated funnel （Hall flowmeter） GB/T 1482-2010


7 Apparent density

Metallic powders-Determination of apparent density-Part1：Funnal method GB/T 1479.1-2011


8 Tap density

Metallic powders-Determination of tap density GB/T 5162-2006

9 Surface roughnessDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.1


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10 sizeDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.2

11 Warpage deformationDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.3

12 HardnessDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.4.1

13 Tensile StrengthDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.4.2

14 Bending strengthDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.4.3

15 Inclusions and porosity

Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances SSTCBM/FB-007-2019 4.2.5

16 DensityDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.6

17 Corrosion resistanceDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.7

18 Tarnish resistanceDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.8

19 Thermal expansion coefficient



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20 The debonding/crack-initiation strength


name: sichuan testing center for biomaterials and medical ... · erythocyte micronucleus test yy/t...

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