織名稱 年份
1 Anesthesias 麻醉學
TFDA-02106 ISO ISO 13320:2020 2020 Particle size analysis — Laser diffraction methods 110 年度新增 採認標準 2 Anesthesias
麻醉學
TFDA-00408 ISO ISO
80601-2-84:2020
2020 Medical electrical equipment — Part 2-84:
Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
原採認標準
3 Anesthesias 麻醉學
TFDA-00409 ISO ISO
10651-4:2002
2002 Lung ventilators -- Part 4: Particular requirements for operator-powered resuscitators
原採認標準
4 Anesthesias 麻醉學
TFDA-00410 ISO ISO
10651-5:2006
2006 Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 5: Gas powered emergency resuscitators
原採認標準
5 Anesthesias 麻醉學
TFDA-00569 CNS CNS 14961 2005 小型醫療氣體鋼瓶－銷針標示軛式閥接頭 原採認標準
6 Anesthesias 麻醉學
TFDA-00570 CNS CNS 14962 2005 氣體鋼瓶－工業與醫療氣體鋼瓶之閥保護帽與
閥保護套－設計、結構與試驗
原採認標準
7 Anesthesias 麻醉學
TFDA-00571 CNS CNS 14963 2005 醫療用氣體混合器－獨立式氣體混合器 原採認標準
麻醉學 11 Anesthesias
麻醉學
TFDA-01156 CNS CNS 14776 2003 醫用面罩對合成血液穿透阻力的試驗法─以已知
速度定量的水平噴灑 (Method of test for
resistance of medical face masks to penetration by synthetic blood (horizontal projection of fixed volume at a known velocity))
原採認標準
12 Anesthesias 麻醉學
TFDA-01157 CNS CNS 14777 2003 醫用面罩空氣交換壓力之試驗法 (Method of test for air exchange pressure of medical face mask)
原採認標準
13 Anesthesias 麻醉學
TFDA-01158 CNS CNS 6636 2013 呼吸防護裝置-氣體濾材及組合型濾材-要求、試
驗、標示 (Respiratory protective devices - Gas filters and combined filters - Requirements, testing, marking)
原採認標準
14 Anesthesias 麻醉學
TFDA-01167 ISO ISO
23328-1:2003
2003 Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance
原採認標準
15 Anesthesias 麻醉學
TFDA-01168 ISO ISO
23328-2:2002
2002 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects
原採認標準
16 Anesthesias 麻醉學
TFDA-01170 ISO ISO
26782:2009/Cor1:
2009
2009 Anaesthetic and respiratory equipment -
Spirometers intended for the measurement of time forced expired volumes in humans
原採認標準
18 Anesthesias 麻醉學
TFDA-01454 ISO ISO
10079-2:2014
2014 Medical suction equipment - Part 2: Manually powered suction equipment
原採認標準
19 Anesthesias 麻醉學
TFDA-01455 ISO ISO
10079-3:2014
2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or pressure source
原採認標準
20 Anesthesias 麻醉學
TFDA-01456 ISO ISO 14408:2016 2016 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
原採認標準
21 Anesthesias 麻醉學
TFDA-01457 ISO ISO 23747:2015 2015 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
原採認標準
22 Anesthesias 麻醉學
TFDA-01459 ISO ISO 5360:2016 2016 Anaesthetic vaporizers - Agent-specific filling systems
原採認標準
23 Anesthesias 麻醉學
TFDA-01460 ISO ISO 5361:2016 2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
原採認標準
24 Anesthesias 麻醉學
TFDA-01461 ISO ISO 5364:2016 2016 Anaesthetic and respiratory equipment - Oropharyngeal airways
原採認標準 25 Anesthesias TFDA-01462 ISO ISO 5366:2016 2016 Anaesthetic and respiratory equipment - 原採認標準
28 Anesthesias 麻醉學
TFDA-01465 ISO ISO
80369-7:2021
2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
原採認標準
29 Anesthesias 麻醉學
TFDA-01467 ISO ISO
80601-2-67:2020
2020 Medical electrical equipment — Part 2-67:
Particular requirements for basic safety and essential performance of oxygen-conserving equipment
原採認標準
30 Anesthesias 麻醉學
TFDA-01468 ISO ISO
80601-2-69:2020
2020 Medical electrical equipment — Part 2-69:
Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
原採認標準
31 Anesthesias 麻醉學
TFDA-01765 ISO ISO 10524-1:
2018
2018 Pressure regulators for use with medical gases.
Pressure regulators and pressure regulators with flow-metering devices
原採認標準
32 Anesthesias 麻醉學
TFDA-01766 ISO ISO 10524-2:
2018
2018 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators
原採認標準
33 Anesthesias 麻醉學
TFDA-01767 ISO ISO 17510:2015 2015 Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
原採認標準
34 Anesthesias 麻醉學
TFDA-01768 ISO ISO 5356-1:2015 2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
原採認標準
麻醉學 80601-2-55:2018 requirements for the basic safety and essential performance of respiratory gas monitors 37 Anesthesias
麻醉學
TFDA-01772 ISO ISO
80601-2-70:2020
2020 Medical electrical equipment — Part 2-70:
Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
原採認標準
38 Anesthesias 麻醉學
TFDA-01773 ISO ISO
80601-2-74:2017
2017 Medical electrical equipment—Part 2–74: Particular requirements for basic safety and essential
performance of respiratory humidifying equipment
原採認標準
39 Anesthesias 麻醉學
TFDA-01873 ISO ISO
10079-1:2015/A MD 1:2018
2018 Medical suction equipment Part 1: Electrically powered suction equipment - Safety requirements
原採認標準
40 Anesthesias 麻醉學
TFDA-01874 ISO ISO
80601-2-13:2011/
Amd 2:2018
2011 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential
performance of an anaesthetic workstation
原採認標準
41 Anesthesias 麻醉學
TFDA-01930 EN EN ISO 27427 : 2019
2019 Anaesthetic and respiratory equipment - Nebulizing systems and components
原採認標準
42 Anesthesias 麻醉學
TFDA-01931 ISO ISO
10524-3:2019
2019 Pressure regulators for use with medical gases – Part 3:Pressure regulators integrated with cylinder
原採認標準
麻醉學 80601-2-12:2020 requirements for basic safety and essential performance of critical care ventilators 45 Anesthesias
麻醉學
TFDA-01935 ISO ISO 8836:2019 2019 Suction catheters for use in the respiratory tract 原採認標準
46 Anesthesias 麻醉學
TFDA-01936 ISO ISO
5356-2:2012/AM D 1:2019
2019 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors
原採認標準
47 1 Anesthesias 麻醉學
TFDA-02107 ISO ISO 26825 Second edition 2020-10
2020 Anaesthetic and respiratory equipment -
User-applied labels for syringes containing drugs used during anaesthesia - Colours design and performance
110 年度新增 採認標準
48 Biocompatibi lity 生物相 容性
TFDA-00021 ISO ISO
10993-14:2001
2001 Biological evaluation of medical devices -- Part 14:
Identification and quantification of degradation products from ceramics
原採認標準
49 Biocompatibi lity 生物相 容性
TFDA-00024 ISO ISO
10993-17:2002
2002 Biological evaluation of medical devices -- Part 17:
Establishment of allowable limits for leachable substances
原採認標準
50 Biocompatibi lity 生物相 容性
TFDA-00234 CNS CNS 14393-7 2005 醫療器材生物性評估－第７部：環氧乙烷滅菌之 殘留物 Biological evaluation of medical devices - Part 7: ethylene oxide sterilisation residuals
原採認標準
10993-8:2000) 52 Biocompatibi
lity 生物相 容性
TFDA-00236 CNS CNS 14393-10 2005 醫療器材生物性評估－第１０部：刺激性及延遲
型過敏性測試 Biological evaluation of medical devices - Part 10 : tests for irritation and
sensitisation
原採認標準
53 Biocompatibi lity 生物相 容性
TFDA-00237 CNS CNS 14393-12 2005 醫療器材生物性評估－第１２部：樣品製備及參
考材料 Biological evaluation of medical devices - Part 12 : sample preparation and reference materials
原採認標準
54 Biocompatibi lity 生物相 容性
TFDA-00238 CNS CNS 14393-6 2004 醫療器材生物性評估－第六部分:植入後的局部
效應測試 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
原採認標準
55 Biocompatibi lity 生物相 容性
TFDA-00239 CNS CNS 14393-11 2005 醫療器材生物性評估－第１１部：全身毒性測試 Biological evaluation of medical devices - Part 11:
tests for systemic toxicity
原採認標準
56 Biocompatibi lity 生物相 容性
TFDA-00348 ISO ISO/TS
10993-20:2006
2006 Biological evaluation of medical devices —Part 20:
Principles and methods for immunotoxicology testing of medical devices
原採認標準
57 Biocompatibi lity 生物相
TFDA-00361 ISO ISO
10993-2:2006
2006 Biological evaluation of medical devices -- Part 2:
Animal welfare requirements
原採認標準
lity 生物相 容性
60 Biocompatibi lity 生物相 容性
TFDA-00365 CNS CNS14393-3 2004 醫療器材生物性評估-第三部份：基因毒性、致癌
性與生殖毒性之試驗
原採認標準
61 Biocompatibi lity 生物相 容性
TFDA-00366 CNS CNS14393-4 2004 醫療器材生物性評估-第四部份：血液接觸特性測
試方法的選擇
原採認標準
62 Biocompatibi lity 生物相 容性
TFDA-00367 CNS CNS14393-5 2004 醫療器材生物性評估-第五部份：體外細胞毒性試
驗
原採認標準
63 Biocompatibi lity 生物相 容性
TFDA-00368 CNS CNS14393-9 2005 醫療器材生物性評估-第九部份：潛在降解產物之
鑑別與定量分析架構
原採認標準
64 Biocompatibi lity 生物相 容性
TFDA-00369 CNS CNS14393-13 2005 醫療器材生物性評估-第十三部份：聚合物醫療器
材降解產物之鑑別與定量
原採認標準
65 Biocompatibi lity 生物相 容性
TFDA-00370 CNS CNS14393-14 2005 醫療器材生物性評估-第十四部份：陶瓷降解產物
之鑑別與定量
原採認標準
lity 生物相 容性
物之毒性動力學之研究設計
68 Biocompatibi lity 生物相 容性
TFDA-00743 CNS CNS 15153 2007 醫療器材生物性評估－第17 部：可溶出物質容
忍限量之建立
原採認標準
69 Biocompatibi lity 生物相 容性
TFDA-00744 CNS CNS 15154 2007 醫療器材生物性評估－第18 部：材料之化學特
性
原採認標準
70 Biocompatibi lity 生物相 容性
TFDA-00745 CNS CNS 15155 2007 醫療器材生物性評估－第19 部：材料之物理化
學、形態及拓撲學的特性分析
原採認標準
71 Biocompatibi lity 生物相 容性
TFDA-00746 CNS CNS 14393-20 2009 醫療器材生物性評估－第20 部：醫療器材免疫 毒理學試驗之原理與方法
原採認標準
72 Biocompatibi lity 生物相 容性
TFDA-00858 ISO ISO
10993-5:2009
2009 Biological evaluation of medical devices -- Part 5:
Tests for in vitro cytotoxicity
原採認標準
73 Biocompatibi lity 生物相
TFDA-00860 ISO ISO
10993-13:2010
2010 Biological evaluation of medical devices -- Part 13:
Identification and quantification of degradation
原採認標準
lity 生物相 容性
Toxicity of Material Extracts by Systemic Injection in the Mouse
76 Biocompatibi lity 生物相 容性
TFDA-01023 ASTM ASTM F813 - 20 2020 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
原採認標準
77 Biocompatibi lity 生物相 容性
TFDA-01024 ISO ISO
10993-12:2021
2021 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
原採認標準
78 Biocompatibi lity 生物相 容性
TFDA-01471 ISO ISO
10993-3:2014
2014 Biological evaluation of medical devices -- Part 3:
Tests for genotoxicity, carcinogenicity and reproductive toxicity
原採認標準
79 Biocompatibi lity 生物相 容性
TFDA-01472 ISO ISO
10993-6:2016
2016 Biological evaluation of medical devices, Part 6:
Tests for local effects after implantation
原採認標準
80 Biocompatibi lity 生物相 容性
TFDA-01473 ISO AAMI/ISO TIR37137:2014
2014 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
原採認標準
81 Biocompatibi lity 生物相 容性
TFDA-01474 ISO ISO/TR
10993-33 :2015
2015 Biological evaluation of medical devices - Part 33:
Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3 - First Edition
原採認標準
lity 生物相 容性
10993-11:2017 11:Tests for systemic toxicity
84 Biocompatibi lity 生物相 容性
TFDA-01777 ISO ISO
10993-16:2017
2017 Biological evaluation of medical devices -- Part 16:Toxicokinetic study design for degradation products and leachables
原採認標準
85 Biocompatibi lity 生物相 容性
TFDA-01778 ISO ISO
10993-4:2017
2017 Biological evaluation of medical devices -- Part 4:Selection of tests for interactions with blood
原採認標準
86 Biocompatibi lity 生物相 容性
TFDA-01779 ISO ISO
18562-1:2017
2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1:
Evaluation and testing within a risk management process
原採認標準
87 Biocompatibi lity 生物相 容性
TFDA-01780 ISO ISO
18562-2:2017
2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
原採認標準
88 Biocompatibi lity 生物相 容性
TFDA-01781 ISO ISO
18562-3:2017
2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)
原採認標準
容性 Thromboplastin Time (PTT) 91 Biocompatibi
lity 生物相 容性
TFDA-01937 ISO ISO
10993-1:2018
2018 Biological evaluation of medical devices -- Part 1:Evaluation and testing within a risk management process
原採認標準
92 Biocompatibi lity 生物相 容性
TFDA-01938 ASTM ASTM F2148-18 2018 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
原採認標準
93 Biocompatibi lity 生物相 容性
TFDA-01939 ISO ISO
10993-15:2019
2019 Biological evaluation of medical devices -- Part 15:
Identification and quantification of degradation products from metals an
原採認標準
94 Biocompatibi lity 生物相 容性
TFDA-01940 ISO ISO
10993-18:2020
2020 Biological evaluation of medical devices —Part 18:
Chemical characterization of materials
原採認標準
95 Biocompatibi lity 生物相 容性
TFDA-01941 ISO ISO/TS
10993-19:2020
2020 Biological evaluation of medical devices —Part 19:
Physico-chemical, morphological and topographical characterization of materials
原採認標準
96 Biocompatibi lity 生物相 容性
TFDA-01942 ISO ISO
10993-9:2019
2019 Biological evaluation of medical devices -- Part 9:
Framework for identification and quantification of potential degradation products
原採認標準
97 Biocompatibi TFDA-01943 ASTM ASTM F719 - 20 2020 Standard Practice for Testing Biomaterials in 原採認標準
容性
99 Biocompatibi lity 生物相 容性
TFDA-01945 ISO ISO
10993-7:2008/A md 1:2019
2019 Biological evaluation of medical devices -- Part 7:
Ethylene oxide sterilization residuals
原採認標準
100 Biocompatibi lity 生物相 容性
TFDA-02108 ASTM ASTM F619-20 2020 Standard Practice for Extraction of Materials Used in Medical Devices
110 年度新增 採認標準
101 Biocompatibi lity 生物相 容性
TFDA-02109 ASTM ASTM F1408-20a 2020 Standard Practice for Subcutaneous Screening Test for Implant Materials
110 年度新增 採認標準
102 Biocompatibi lity 生物相 容性
TFDA-02110 CEN ISO
EN ISO
10993-23:2021
2021 Biological evaluation of medical devices - Part 23:
Tests for irritation
110 年度新增 採認標準
103 Cardiovascul ar 心臟血管 醫學
TFDA-00314 ISO ISO 11318:2002 2002 Cardiac Defibrillators - Connector Assembly for Implantable Defibrillators - Dimensional and Test Requirements
原採認標準
104 Cardiovascul ar 心臟血管 醫學
TFDA-00780 CNS CNS 13075 2007 非侵入式自動血壓計 原採認標準
醫學
107 Cardiovascul ar 心臟血管 醫學
TFDA-00783 CNS CNS 15041-3 2007 非侵入式血壓計－第3 部：機電式血壓量測系統 的補充規定
原採認標準
108 Cardiovascul ar 心臟血管 醫學
TFDA-00975 OIML OIML R16-2:2002
2002 Non-invasive automated sphygmomanometers 原採認標準
109 Cardiovascul ar 心臟血管 醫學
TFDA-00978 CEN EN 1060-4:2004 2004 Non-invasive sphygmomanometers—Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers
原採認標準
110 Cardiovascul ar 心臟血管 醫學
TFDA-01179 AAMI AAMI
EC53:2013(R202 0)
2020 ECG trunk cables and patient leadwires 原採認標準
111 Cardiovascul ar 心臟血管 醫學
TFDA-01180 AAMI ANSI/AAMI EC57:2012 (R2020)
2020 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
原採認標準
112 Cardiovascul ar 心臟血管 醫學
TFDA-01181 AAMI AAMI/IEC 60601-2-4:2010/
A1:2018
2018 Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential
performance of cardiac defibrillators
原採認標準
ar 心臟血管 醫學
Reporting of Clinical Performance of Populations of Pulse Generators or Leads - Third Edition 115 Cardiovascul
ar 心臟血管 醫學
TFDA-01203 IEC IEC
60601-2-34:2011 ed3.0
2011 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
原採認標準
116 Cardiovascul ar 心臟血管 醫學
TFDA-01205 IEC IEC
60601-2-47:2012 ed2.0
2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
原採認標準
117 Cardiovascul ar 心臟血管 醫學
TFDA-01208 ISO ISO
10555-4:2013
2013 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters - Second Edition
原採認標準
118 Cardiovascul ar 心臟血管 醫學
TFDA-01210 ISO ISO
17475:2005/COR 1:2006
2005 Corrosion of metals and alloys -- Electrochemical test methods -- Guidelines for conducting
potentiostatic and potentiodynamic polarization measurements
原採認標準
119 Cardiovascul ar 心臟血管
TFDA-01211 ISO ISO 2248:1985 1985 Packaging -- Complete, filled transport packages -- Vertical impact test by dropping
原採認標準
ar 心臟血管 醫學
25539-3:2011 Part 3: Vena cava filters
122 Cardiovascul ar 心臟血管 醫學
TFDA-01215 ISO ISO 5841-3:2013 2013 Implants for surgery -- Cardiac pacemakers -- Part 3: Low-profile connectors (IS-1) for implantable pacemakers
原採認標準
123 Cardiovascul ar 心臟血管 醫學
TFDA-01218 ISO ISO
81060-1:2007
2007 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for nonautomated measurement type.
原採認標準
124 Cardiovascul ar 心臟血管 醫學
TFDA-01220 ISO ISO 8318:2000 2000 Packaging - Complete, Filled Transport Packages and Unit Laods - Sinusoidal Vibration Tests Using a Variable Frequency - Second Edition
原採認標準
125 Cardiovascul ar 心臟血管 醫學
TFDA-01478 ASTM ASTM
F2082/F2082M-1 6
2016 Standard Test Method for Determination of Transformation Temperature of Nickel- Titanium Shape Memory Alloys by Bend and Free Recovery
原採認標準
126 Cardiovascul ar 心臟血管 醫學
TFDA-01481 ASTM ASTM F3036-13 2013 Standard Guide for Testing Absorbable Stents 原採認標準
127 Cardiovascul ar 心臟血管 醫學
TFDA-01482 IEC IEC
60601-2-27:2011
2011 Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring
原採認標準
membrane oxygenation (ECMO) 129 Cardiovascul
ar 心臟血管 醫學
TFDA-01486 ISO ISO
25539-1:2017
2017 Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
原採認標準
130 Cardiovascul ar 心臟血管 醫學
TFDA-01487 ISO ISO 5840-1:2021 2021 Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
原採認標準
131 Cardiovascul ar 心臟血管 醫學
TFDA-01488 ISO ISO 5840-2:2021 2021 Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
原採認標準
132 Cardiovascul ar 心臟血管 醫學
TFDA-01489 ISO ISO 5840-3:2021 2021 Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
原採認標準
133 Cardiovascul ar 心臟血管 醫學
TFDA-01490 ISO ISO 7198:2016 2016 Cardiovascular implants and extracorporeal systems—Vascular prostheses—Tubular vascular grafts and vascular patches
原採認標準
134 Cardiovascul ar 心臟血管 醫學
TFDA-01492 ISO ISO
12417-1:2015
2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
原採認標準
醫學 AMD1:2018 performance of cardiac defibrillators 137 Cardiovascul
ar 心臟血管 醫學
TFDA-01785 IEC IEC
80601-2-30:2018
2018 Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
原採認標準
138 Cardiovascul ar 心臟血管 醫學
TFDA-01786 IEC IEC
80601-2-49:2018
2018 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
原採認標準
139 Cardiovascul ar 心臟血管 醫學
TFDA-01787 ISO ISO
11070 :2014+A1:
2018
2014 Sterile single-use intravascular introducers, dilators and guidewires
原採認標準
140 Cardiovascul ar 心臟血管 醫學
TFDA-01788 ISO ISO
80601-2-61:2017
2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential
performance of pulse oximeter equipment
原採認標準
141 Cardiovascul ar 心臟血管 醫學
TFDA-01876 AAMI ANSI/AAMI EC12:2000 (R2020)
2020 Disposable ECG electrodes 原採認標準
142 Cardiovascul ar 心臟血管 醫學
TFDA-01877 AAMI IEC
60601-2-25:2011(
R2016)
2016 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
原採認標準
ar 心臟血管 醫學
99(2018) Complement Activation in Serum by Solid Materials
145 Cardiovascul ar 心臟血管 醫學
TFDA-01880 ASTM ASTM F2079 - 09(2017)
2017 Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon Expandable Stents
原採認標準
146 Cardiovascul ar 心臟血管 醫學
TFDA-01881 ASTM ASTM F2394 - 07(2017)
2017 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
原採認標準
147 Cardiovascul ar 心臟血管 醫學
TFDA-01882 ASTM ASTM F746 - 04(2021)
2021 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
原採認標準
148 Cardiovascul ar 心臟血管 醫學
TFDA-01946 ISO ISO 8637-3:2018 2018 Extracorporeal systems for blood purification - Part 3: Plasmafilters
原採認標準
149 Cardiovascul ar 心臟血管 醫學
TFDA-01947 ISO ISO
81060-2:2018/A MD 1:2020
2020 Non-invasive sphygmomanometers - Part 2:
Clinical investigation of automated measurement type - Second Edition
原採認標準
150 Cardiovascul ar 心臟血管
TFDA-01948 ASTM ASTM F3320-18 2018 Standard Guide for Coating Characterization of Drug Coated Balloons
原採認標準
ar 心臟血管 醫學
14117:2019 devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices.
153 Cardiovascul ar 心臟血管 醫學
TFDA-01951 ASTM ASTM G71 - 81(2019)
2019 Standard Guide for Conducting and Evaluating Galvanic Corrosion Tests in Electrolytes
原採認標準
154 Cardiovascul ar 心臟血管 醫學
TFDA-01952 IEC IEC
60601-2-31:2020
2020 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
原採認標準
155 Cardiovascul ar 心臟血管 醫學
TFDA-01953 ISO ISO
14708-2:2019
2019 Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers
原採認標準
156 Cardiovascul ar 心臟血管 醫學
TFDA-01954 ASTM ASTM F138 - 19 2019 Standard Specification for Wrought 18 Chromium 14 Nickel 2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
原採認標準
157 Cardiovascul ar 心臟血管 醫學
TFDA-01955 ASTM ASTM F2942 - 19
2019 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
原採認標準
ar 心臟血管 醫學
15675:2016/AM D 1:2020
Cardiopulmonary bypass systems - Arterial blood line filters
160 Cardiovascul ar 心臟血管 醫學
TFDA-01958 ISO ISO
7199:2016/AMD 1:2020
2020 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
原採認標準
161 Cardiovascul ar 心臟血管 醫學
TFDA-01959 ISO ISO/TS 17137:2019
2019 Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
原採認標準
162 Cardiovascul ar 心臟血管 醫學
TFDA-02111 ASTM F1830-19 2019 Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps
110 年度新增 採認標準
163 Cardiovascul ar 心臟血管 醫學
TFDA-02112 ASTM F1841-19 2019 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
110 年度新增 採認標準
164 Cardiovascul ar 心臟血管 醫學
TFDA-02113 IEEE IEEE Std 1708-2019
2019 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [including: Amendment 1 (2019)]
110 年度新增 採認標準
165 Cardiovascul ar 心臟血管
TFDA-02114 ISO ISO/TS 81060-5:2020
2020 Non-invasive sphygmomanometers - Part 5:
Requirements for the repeatability and
110 年度新增 採認標準
167 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-00373 ANSI ADA
Specification No.27-1993
1993 Resin-Based Filling Materials 原採認標準
168 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-00381 ISO ISO 6360-3: 2005 2005 Dentistry -- Number coding system for rotary instruments -- Part 3: Specific characteristics of burs and cutters
原採認標準
169 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-00382 ISO ISO 6360-4: 2004 2004 Dentistry -- Number coding system for rotary instruments -- Part 4: Specific characteristics of diamond instruments
原採認標準
170 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-00383 ISO ISO 6360-6: 2004 2004 Dentistry -- Number coding system for rotary instruments -- Part 6: Specific characteristics of abrasive instruments
原採認標準
171 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-00384 ISO ISO 6360-7: 2006 2006 Dentistry – Number coding system for rotary instruments – Part 7: Specific characteristics of mandrels and special instruments
原採認標準
172 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-00385 ISO ISO
13397-1:1995
1995 Periodontal curettes, dental scalers and excavators -- Part 1: General requirements
原採認標準
173 Dental/ENT 牙科學/耳鼻
TFDA-00387 ISO ISO
13397-3:1996
1996 Periodontal curettes, dental scalers and excavators -- Part 3: Dental scalers -- H-type
原採認標準
175 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-00389 ISO ISO 15854:2021 2021 Dentistry – Casting and baseplate waxes 原採認標準
176 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-00687 ISO ISO 6877:2006 2006 Dentistry -- Root-canal obturating points 原採認標準
177 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-00690 ISO ISO 9917-1:2007 2007 Dentistry -- Water-based cements -- Part 1:
Powder/liquid acid-base cements
原採認標準
178 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-00873 ISO ISO 9168:2009 2009 Dentistry -- Hose connectors for air driven dental handpieces
原採認標準
179 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01223 CEN EN 1639:2009 2009 Dentistry. Medical devices for dentistry.
Instruments
原採認標準
180 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01224 CEN EN 1640:2009 2009 Dentistry. Medical devices for dentistry. Equipment 原採認標準
181 Dental/ENT TFDA-01225 CEN EN 1641:2009 2009 Dentistry. Medical devices for dentistry. Materials 原採認標準
183 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01229 ISO ISO
13397-2:2005/A md1:2012
2012 Dentistry – Periodontal curettes, dental scalers and excavators – Part 2:Periodontal curettes of Gr-type
原採認標準
184 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01232 ISO ISO 21563:2013 2013 Dentistry - Hydrocolloid impression materials - First Edition
原採認標準
185 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01233 ISO ISO 3107:2011 2011 Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements - Fourth Edition
原採認標準
186 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01234 ISO ISO
6360-2:2004/Am d 1:2011
2011 Dentistry — Number coding system for rotary instruments — Part 2: Shapes AMENDMENT 1 - Second Edition
原採認標準
187 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01235 ISO ISO 6876:2012 2012 Dentistry - Root canal sealing materials - Third Edition
原採認標準
188 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01238 ADA ANSI/ADA 96-2012
2012 ANSI/ADA Standard No. 96—Dental Water-based Cements: 2012
原採認標準
189 Dental/ENT 牙科學/耳鼻
TFDA-01494 AAMI AAMI CI86:2017 2017 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability
原採認標準
191 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01498 ISO ISO 14801:2016 2016 Dentistry - Implants - Dynamic loading test for endosseous dental implants
原採認標準
192 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01499 ISO ISO 22674:2016 2016 Dentistry -- Metallic materials for fixed and removable restorations and appliances
原採認標準
193 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01500 ISO ISO
6360-1:2004/Cor 1:2007
2007 Dentistry — Number coding system for rotary instruments — Part 1: General characteristics
原採認標準
194 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01502 ISO ISO 6874:2015 2015 Dentistry — Polymer-based pit and fissure sealants 原採認標準
195 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01504 ISO ISO 7494-2:201 5
2015 Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems - Second Edition
原採認標準
196 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01789 ISO ISO
10139-1:2018
2018 Dentistry - Soft lining materials for removable dentures - Part 1:Materials for short-term use
原採認標準
197 Dental/ENT TFDA-01790 ISO ISO 10477:2020 2020 Dentistry -- Polymer-based crown and bridge 原採認標準
199 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01792 ISO ISO 14457:2017 2017 Dentistry -- Handpieces and motors 原採認標準
200 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01793 ISO ISO 22112:2017 2017 Dentistry - Artificial teeth for dental prostheses 原採認標準
201 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01794 ISO ISO 7491:2000 2000 Dental materials—Determination of colour stability 原採認標準
202 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01795 ISO ISO 7494-1:2018 2018 Dentistry -- Dental units -- Part 1: General requirements and test methods
原採認標準
203 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01796 ISO ISO 9917-2:2017 2017 Dentistry - Water-based cements - Part 2:
Resin-modified cements
原採認標準
204 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01883 ASA ASA S3.6-2018 2018 American National Standard Specification for Audiometers
原採認標準
205 Dental/ENT 牙科學/耳鼻
TFDA-01884 ISO ISO
6872:2015/AMD
2018 Dentistry - Ceramic materials 原採認標準
207 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01961 ASTM ASTM F1088-18 2018 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
原採認標準
208 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01962 ISO ISO 7405:2018 2018 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry
原採認標準
209 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01963 ISO ISO 17730:2020 2020 Dentistry - Fluoride varnishes 原採認標準
210 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01964 ISO ISO 4049:2019 2019 Dentistry -- Polymer-based restorative materials 原採認標準
211 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01965 IEC IEC
80601-2-60:2019
2019 Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
原採認標準
212 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-01966 ASA ASA S3.22-2014 (R2020)
2020 Specification of Hearing Aid Characteristics 原採認標準
213 Dental/ENT TFDA-01967 IEC IEC 2019 Medical electrical equipment Part 2-66: Particular 原採認標準
喉科學 and/or inactivation of transmissible spongiform encephalopathy22agents and validation assays for those processes
215 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-02117 ISO ISO 10650 Second edition 2018-08
2018 Dentistry — Powered polymerization activators 110 年度新增 採認標準
216 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-02118 ANSI ASA
ANSI ASA S3.7-2016 (Reaffirmed 2020)
2020 American National Standard Method for Coupler Calibration of Earphones
110 年度新增 採認標準
217 Dental/ENT 牙科學/耳鼻 喉科學
TFDA-02119 ISO ISO 10271 Third edition 2020-08
2020 Dentistry - Corrosion test methods for metallic materials
110 年度新增 採認標準
218 General I (QS/RM) 通 用(品質管理 系統/風險管 理)
TFDA-00088 ISO ISO 10012:2003 2003 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
原採認標準
219 General I (QS/RM) 通
TFDA-00439 CNS CNS14991 2006 命名─用於醫療器材法規管理資料交換之命名系
統的規格
原採認標準
(QS/RM) 通 用(品質管理 系統/風險管 理)
221 General I (QS/RM) 通 用(品質管理 系統/風險管 理)
TFDA-00441 CNS CNS14990 2006 醫療器材─用於醫療器材標識、標示與資訊之符
號
原採認標準
222 General I (QS/RM) 通 用(品質管理 系統/風險管 理)
TFDA-01013 ISO ISO 14155:2020 2020 Clinical investigation of medical devices for human subjects -- Good clinical practice
原採認標準
223 General I (QS/RM) 通 用(品質管理 系統/風險管 理)
TFDA-01505 AAMI AAMI
TIR69:2017(R20 20)
2020 Risk management of radio-frequency wireless coexistence for medical devices and systems
原採認標準
