衛生福利部食品藥物管理署醫療器材標準採認資料

1/121

附件 1、109 年度醫療器材採認標準總清單(1,000 項)。

序號 標準類別

採認編號

標準組 織名稱

標準號碼

年份

標準名稱 採認說明

1 1 Anesthesias 麻醉學

TFDA-00408 ISO ISO 10651-3:1997

Lung ventilators for medical use -- Part 3: Particular requirements for emergency and transport ventilators

原採認標準

2 1 Anesthesias 麻醉學

TFDA-00409 ISO ISO 10651-4:2002

Lung ventilators -- Part 4: Particular requirements for operator-powered resuscitators

原採認標準

3 1 Anesthesias 麻醉學

TFDA-00410 ISO ISO 10651-5:2006

Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 5: Gas powered emergency resuscitators

原採認標準

4 1 Anesthesias 麻醉學

TFDA-00569 CNS CNS 14961

小型醫療氣體鋼瓶－銷針標示軛式閥接頭 原採認標準

5 1 Anesthesias 麻醉學

TFDA-00570 CNS CNS 14962

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

6 1 Anesthesias 麻醉學

TFDA-00571 CNS CNS 14963

醫療用氣體混合器－獨立式氣體混合器 原採認標準

7 1 Anesthesias 麻醉學

TFDA-00574 CNS CNS 15004

醫療氣體管線系統使用之氧氣濃縮機 原採認標準

8 1 Anesthesias 麻醉學

TFDA-00577 CNS CNS 15006

連接於醫療氣體管線系統終端單元之流量計裝置 原採認標準

9 1 Anesthesias 麻醉學

TFDA-00727 ISO ISO 5362:2006

Anaesthetic reservoir bags 原採認標準

2/121

10 1 Anesthesias 麻醉學

TFDA-01156 CNS CNS 14776

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

11 1 Anesthesias 麻醉學

TFDA-01157 CNS CNS 14777

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

12 1 Anesthesias 麻醉學

TFDA-01158 CNS CNS 6636

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

13 1 Anesthesias 麻醉學

TFDA-01167 ISO ISO 23328-1:2003

Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance

原採認標準

14 1 Anesthesias 麻醉學

TFDA-01168 ISO ISO 23328-2:2002

Breathing system filters for anaesthetic and respiratory use - Part 2:

Non-filtration aspects

原採認標準

15 1 Anesthesias 麻醉學

TFDA-01170 ISO ISO

26782:2009/Cor1:200 9

2009

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans

原採認標準

16 1 Anesthesias 麻醉學

TFDA-01452 ASTM ASTM G175-13

Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications

原採認標準

17 1 Anesthesias 麻醉學

TFDA-01454 ISO ISO 10079-2:2014

Medical suction equipment - Part 2: Manually powered suction equipment 原採認標準

18 1 Anesthesias 麻醉學

TFDA-01455 ISO ISO 10079-3:2014

Medical suction equipment Part 3: Suction equipment powered from a vacuum or pressure source

原採認標準

3/121

19 1 Anesthesias 麻醉學

TFDA-01456 ISO ISO 14408:2016

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information

原採認標準

20 1 Anesthesias 麻醉學

TFDA-01457 ISO ISO 23747:2015

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

原採認標準

21 1 Anesthesias 麻醉學

TFDA-01459 ISO ISO 5360:2016

Anaesthetic vaporizers - Agent-specific filling systems 原採認標準

22 1 Anesthesias 麻醉學

TFDA-01460 ISO ISO 5361:2016

Anaesthetic and respiratory equipment — Tracheal tubes and connectors 原採認標準

23 1 Anesthesias 麻醉學

TFDA-01461 ISO ISO 5364:2016

Anaesthetic and respiratory equipment - Oropharyngeal airways 原採認標準

24 1 Anesthesias 麻醉學

TFDA-01462 ISO ISO 5366:2016

Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors

原採認標準

25 1 Anesthesias 麻醉學

TFDA-01463 ISO ISO 5367:2014

Breathing Tubes intended for use with Anaesthetic Apparatus and Ventilators

原採認標準

26 1 Anesthesias 麻醉學

TFDA-01464 ISO ISO 7376:2009

Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation

原採認標準

27 1 Anesthesias 麻醉學

TFDA-01465 ISO ISO 80369-7:2016

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

原採認標準

28 1 Anesthesias 麻醉學

TFDA-01467 ISO ISO 80601-2-67:2014

Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment

原採認標準

29 1 Anesthesias 麻醉學

TFDA-01468 ISO ISO 80601-2-69:2014

Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

原採認標準

30 1 Anesthesias 麻醉學

TFDA-01765 ISO ISO 10524-1: 2018

Pressure regulators for use with medical gases. Pressure regulators and pressure regulators with flow-metering devices

原採認標準

4/121

31 1 Anesthesias 麻醉學

TFDA-01766 ISO ISO 10524-2: 2018

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators

原採認標準

32 1 Anesthesias 麻醉學

TFDA-01767 ISO ISO 17510:2015

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories

原採認標準

33 1 Anesthesias 麻醉學

TFDA-01768 ISO ISO 5356-1:2015

Anaesthetic and respiratory equipment - Conical connectors - Part 1:

Cones and sockets

原採認標準

34 1 Anesthesias 麻醉學

TFDA-01770 ISO ISO 5359:2014/AMD 1:2017

2017

Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases

原採認標準

35 1 Anesthesias 麻醉學

TFDA-01771 ISO ISO 80601-2-55:2018

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

原採認標準

36 1 Anesthesias 麻醉學

TFDA-01772 ISO ISO 80601-2-70:2015

Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

原採認標準

37 1 Anesthesias 麻醉學

TFDA-01773 ISO ISO 80601-2-74:2017

Medical electrical equipment—Part 2–74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

原採認標準

38 1 Anesthesias 麻醉學

TFDA-01873 ISO ISO 10079-1:2015 /AMD 1:2018

2018

Medical suction equipment Part 1: Electrically powered suction equipment - Safety requirements

原採認標準

39 1 Anesthesias 麻醉學

TFDA-01874 IEC 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

40 1 Anesthesias 麻醉學

TFDA-01930 EN EN ISO 27427 : 2019

Anaesthetic and respiratory equipment - Nebulizing systems and components

109 年度新 增採認標準 41 1 Anesthesias

麻醉學

TFDA-01931 ISO ISO 10524-3:2019

Pressure regulators for use with medical gases – Part 3:Pressure regulators integrated with cylinder valves

109 年度新

增採認標準

5/121

42 1 Anesthesias 麻醉學

TFDA-01932 ISO ISO 80369-1:2018

Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements

109 年度新 增採認標準 43 1 Anesthesias

麻醉學

TFDA-01933 ISO ISO 10079-1/AMD 1:2018

2018

Medical suction equipment Part 1: Electrically powered suction equipment - Safety requirements

109 年度新 增採認標準 44 1 Anesthesias

麻醉學

TFDA-01934 ISO ISO 80601-2-12:2020

Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

109 年度新 增採認標準 45 1 Anesthesias

麻醉學

TFDA-01935 ISO ISO 8836:2019

Suction catheters for use in the respiratory tract 109 年度新 增採認標準 46 1 Anesthesias

麻醉學

TFDA-01936 ISO ISO 5356-2:2012 /AMD 1:2019

2019

Anaesthetic and respiratory equipment - Conical connectors - Part 2:

Screw-threaded weight-bearing connectors

109 年度新 增採認標準 47 2 Biocompatibility

生物相容性

TFDA-00021 ISO ISO 10993-14:2001

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

原採認標準

48 2 Biocompatibility 生物相容性

TFDA-00024 ISO ISO 10993-17:2002

Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances

原採認標準

49 2 Biocompatibility 生物相容性

TFDA-00234 CNS CNS 14393-7

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

50 2 Biocompatibility 生物相容性

TFDA-00235 CNS CNS 14393-8

醫療器材生物性評估－第８部：生物測試用參考材料之選擇及資格認

定 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)

原採認標準

51 2 Biocompatibility 生物相容性

TFDA-00236 CNS CNS 14393-10

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

6/121

52 2 Biocompatibility 生物相容性

TFDA-00237 CNS CNS 14393-12

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

53 2 Biocompatibility 生物相容性

TFDA-00238 CNS CNS 14393-6

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

54 2 Biocompatibility 生物相容性

TFDA-00239 CNS CNS 14393-11

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

55 2 Biocompatibility 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

56 2 Biocompatibility 生物相容性

TFDA-00361 ISO ISO 10993-2:2006

Biological evaluation of medical devices -- Part 2: Animal welfare requirements

原採認標準

57 2 Biocompatibility 生物相容性

TFDA-00363 CNS CNS14393-1

醫療器材生物性評估-第一部份：評估與試驗 原採認標準

58 2 Biocompatibility 生物相容性

TFDA-00364 CNS CNS14393-2

醫療器材生物性評估-第二部份：動物福利之規定 原採認標準

59 2 Biocompatibility 生物相容性

TFDA-00365 CNS CNS14393-3

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

60 2 Biocompatibility 生物相容性

TFDA-00366 CNS CNS14393-4

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

61 2 Biocompatibility 生物相容性

TFDA-00367 CNS CNS14393-5

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

62 2 Biocompatibility 生物相容性

TFDA-00368 CNS CNS14393-9

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

7/121

63 2 Biocompatibility 生物相容性

TFDA-00369 CNS CNS14393-13

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

64 2 Biocompatibility 生物相容性

TFDA-00370 CNS CNS14393-14

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

65 2 Biocompatibility 生物相容性

TFDA-00371 CNS CNS14393-15

醫療器材生物性評估-第十五部份：金屬集合金之降解產物的鑑別與定

量

原採認標準

66 2 Biocompatibility 生物相容性

TFDA-00372 CNS CNS14393-16

醫療器材生物性評估-第十六部份：降解及可溶出物之毒性動力學之研

究設計

原採認標準

67 2 Biocompatibility 生物相容性

TFDA-00743 CNS CNS 15153

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

68 2 Biocompatibility 生物相容性

TFDA-00744 CNS CNS 15154

醫療器材生物性評估－第 18 部：材料之化學特性 原採認標準

69 2 Biocompatibility 生物相容性

TFDA-00745 CNS CNS 15155

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

70 2 Biocompatibility 生物相容性

TFDA-00746 CNS CNS 14393-20

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

71 2 Biocompatibility 生物相容性

TFDA-00858 ISO ISO 10993-5:2009

Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

原採認標準

72 2 Biocompatibility 生物相容性

TFDA-00860 ISO ISO 10993-13:2010

Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices

原採認標準

73 2 Biocompatibility 生物相容性

TFDA-00862 ISO ISO 10993-10:2010

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

原採認標準

74 2 Biocompatibility 生物相容性

TFDA-01022 ASTM ASTM

F750-87/(R)2012

2012

Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse

原採認標準

8/121

75 2 Biocompatibility 生物相容性

TFDA-01023 ASTM F813 - 07(2012)

Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

原採認標準

76 2 Biocompatibility 生物相容性

TFDA-01024 ISO ISO 10993-12:2012

Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials

原採認標準

77 2 Biocompatibility 生物相容性

TFDA-01471 ISO ISO 10993-3:2014

Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

原採認標準

78 2 Biocompatibility 生物相容性

TFDA-01472 ISO ISO 10993-6:2016

Biological evaluation of medical devices, Part 6: Tests for local effects after implantation

原採認標準

79 2 Biocompatibility 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

80 2 Biocompatibility 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

81 2 Biocompatibility 生物相容性

TFDA-01775 ASTM ASTM F720-17

Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

原採認標準

82 2 Biocompatibility 生物相容性

TFDA-01776 ISO ISO 10993-11:2017

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

原採認標準

83 2 Biocompatibility 生物相容性

TFDA-01777 ISO ISO 10993-16:2017

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

原採認標準

84 2 Biocompatibility 生物相容性

TFDA-01778 ISO ISO 10993-4:2017

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

原採認標準

85 2 Biocompatibility 生物相容性

TFDA-01779 ISO ISO 18562-1:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process

原採認標準

9/121

86 2 Biocompatibility 生物相容性

TFDA-01780 ISO ISO 18562-2:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter

原採認標準

87 2 Biocompatibility 生物相容性

TFDA-01781 ISO ISO 18562-3:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)

原採認標準

88 2 Biocompatibility 生物相容性

TFDA-01782 ISO ISO 18562-4:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate

原採認標準

89 2 Biocompatibility 生物相容性

TFDA-01875 ASTM ASTM F2382 - 18

Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)

原採認標準

90 2 Biocompatibility 生物相容性

TFDA-01937 ISO ISO 10993-1:2018

Biological evaluation of medical devices -- Part 1:Evaluation and testing within a risk management process

109 年度新 增採認標準 91 2 Biocompatibility

生物相容性

TFDA-01938 ASTM ASTM F2148-18

Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

109 年度新 增採認標準 92 2 Biocompatibility

生物相容性

TFDA-01939 ISO ISO 10993-15:2019

Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals an

109 年度新 增採認標準 93 2 Biocompatibility

生物相容性

TFDA-01940 ISO ISO 10993-18:2020

Biological evaluation of medical devices —Part 18: Chemical characterization of materials

109 年度新 增採認標準 94 2 Biocompatibility

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

109 年度新 增採認標準 95 2 Biocompatibility

生物相容性

TFDA-01942 ISO ISO 10993-9:2019

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

109 年度新 增採認標準 96 2 Biocompatibility

生物相容性

TFDA-01943 ASTM ASTM F719 - 20

Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

109 年度新

增採認標準

10/121

97 2 Biocompatibility 生物相容性

TFDA-01944 ASTM ASTM F749 - 20

Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

109 年度新 增採認標準 98 2 Biocompatibility

生物相容性

TFDA-01945 ISO ISO 10993-7:2008 /Amd 1:2019

2019

Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

109 年度新 增採認標準 99 3 Cardiovascular

心臟血管醫學

TFDA-00314 ISO ISO 11318:2002

Cardiac Defibrillators - Connector Assembly for Implantable Defibrillators - Dimensional and Test Requirements

原採認標準

100 3 Cardiovascular 心臟血管醫學

TFDA-00780 CNS CNS 13075

非侵入式自動血壓計 原採認標準

101 3 Cardiovascular 心臟血管醫學

TFDA-00781 CNS CNS 15041-1

非侵入式血壓計－第 1 部：一般規定 原採認標準

102 3 Cardiovascular 心臟血管醫學

TFDA-00782 CNS CNS 15041-2

非侵入式血壓計－第 2 部：機械式血壓計之補充規定 原採認標準

103 3 Cardiovascular 心臟血管醫學

TFDA-00783 CNS CNS 15041-3

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

104 3 Cardiovascular 心臟血管醫學

TFDA-00975 OIML OIML R16-2:2002

Non-invasive automated sphygmomanometers 原採認標準

105 3 Cardiovascular 心臟血管醫學

TFDA-00978 CEN EN 1060-4:2004

Non-invasive sphygmomanometers—Part 4: Test procedures to determine the overall system accuracy of automated non-invasive

sphygmomanometers

原採認標準

106 3 Cardiovascular 心臟血管醫學

TFDA-01179 AAMI AAMI EC53:2013

ECG cables and leadwires 原採認標準

107 3 Cardiovascular 心臟血管醫學

TFDA-01180 AAMI AAMI EC57:2012

Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms

原採認標準

11/121

108 3 Cardiovascular 心臟血管醫學

TFDA-01181 AAMI AAMI/IEC 60601-2-4:2010

2010

Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators

原採認標準

109 3 Cardiovascular 心臟血管醫學

TFDA-01195 CEN EN 1060-3:1997 +A2:2009

2009

Non-invasive sphygmomanometers. Supplementary requirements for electro-mechanical blood pressure measuring systems

原採認標準

110 3 Cardiovascular 心臟血管醫學

TFDA-01198 CEN EN ISO 81060-1:2012

2012

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type - CORR: July 31, 2012

原採認標準

111 3 Cardiovascular 心臟血管醫學

TFDA-01200 ISO ISO 5841-2:2014

Implants for Surgery - Cardiac Pacemakers - Part 2: Reporting of Clinical Performance of Populations of Pulse Generators or Leads - Third Edition

原採認標準

112 3 Cardiovascular 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

113 3 Cardiovascular 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

114 3 Cardiovascular 心臟血管醫學

TFDA-01208 ISO ISO 10555-4:2013

Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters - Second Edition

原採認標準

115 3 Cardiovascular 心臟血管醫學

TFDA-01210 ISO ISO 17475:2005

Corrosion of metals and alloys -- Electrochemical test methods --

Guidelines for conducting potentiostatic and potentiodynamic polarization measurements

原採認標準

116 3 Cardiovascular 心臟血管醫學

TFDA-01211 ISO ISO 2248:1985

Packaging -- Complete, filled transport packages -- Vertical impact test by dropping

原採認標準

117 3 Cardiovascular 心臟血管醫學

TFDA-01213 ISO ISO 25539-2:2012

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents 原採認標準

12/121

118 3 Cardiovascular 心臟血管醫學

TFDA-01214 ISO ISO 25539-3:2011

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters 原採認標準

119 3 Cardiovascular 心臟血管醫學

TFDA-01215 ISO ISO 5841-3:2013

Implants for surgery -- Cardiac pacemakers -- Part 3: Low-profile connectors (IS-1) for implantable pacemakers

原採認標準

120 3 Cardiovascular 心臟血管醫學

TFDA-01218 ISO ISO 81060-1:2007

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for nonautomated measurement type.

原採認標準

121 3 Cardiovascular 心臟血管醫學

TFDA-01220 ISO ISO 8318:2000

Packaging - Complete, Filled Transport Packages and Unit Laods - Sinusoidal Vibration Tests Using a Variable Frequency - Second Edition

原採認標準

122 3 Cardiovascular 心臟血管醫學

TFDA-01478 ASTM ASTM

F2082/F2082M-16

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

123 3 Cardiovascular 心臟血管醫學

TFDA-01481 ASTM ASTM F3036-13

Standard Guide for Testing Absorbable Stents 原採認標準

124 3 Cardiovascular 心臟血管醫學

TFDA-01482 IEC IEC 60601-2-27:2011

Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

原採認標準

125 3 Cardiovascular 心臟血管醫學

TFDA-01485 ISO ISO 15676:2016

Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

原採認標準

126 3 Cardiovascular 心臟血管醫學

TFDA-01486 ISO ISO 25539-1:2017

Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses

原採認標準

127 3 Cardiovascular 心臟血管醫學

TFDA-01487 ISO ISO 5840-1:2015

Cardiovascular implants — Cardiac valve prostheses Part 1: General requirements

原採認標準

128 3 Cardiovascular 心臟血管醫學

TFDA-01488 ISO ISO 5840-2:2015

Cardiovascular implants — Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes

原採認標準

13/121

129 3 Cardiovascular 心臟血管醫學

TFDA-01489 ISO ISO 5840-3:2013

Cardiovascular implants - Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques

原採認標準

130 3 Cardiovascular 心臟血管醫學

TFDA-01490 ISO ISO 7198:2016

Cardiovascular implants and extracorporeal systems—Vascular prostheses—Tubular vascular grafts and vascular patches

原採認標準

131 3 Cardiovascular 心臟血管醫學

TFDA-01492 ISO ISO 12417-1:2015

Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements

原採認標準

132 3 Cardiovascular 心臟血管醫學

TFDA-01783 ASTM ASTM F2004-17

Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis

原採認標準

133 3 Cardiovascular 心臟血管醫學

TFDA-01784 IEC IEC 60601-2-4:2010 +AMD1:2018

2018

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

原採認標準

134 3 Cardiovascular 心臟血管醫學

TFDA-01785 IEC IEC 80601-2-30:2018

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

135 3 Cardiovascular 心臟血管醫學

TFDA-01786 IEC IEC 80601-2-49:2018

Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

原採認標準

136 3 Cardiovascular 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

137 3 Cardiovascular 心臟血管醫學

TFDA-01788 ISO ISO 80601-2-61:2017

Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

原採認標準

138 3 Cardiovascular 心臟血管醫學

TFDA-01876 AAMI AMMI

EC12:2000/(R2015)

2015

Disposable ECG electrodes 原採認標準

139 3 Cardiovascular 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

14/121

140 3 Cardiovascular 心臟血管醫學

TFDA-01878 ASTM ASTM F2081 - 06(2017)

2017

Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

原採認標準

141 3 Cardiovascular 心臟血管醫學

TFDA-01879 ASTM ASTM F1984 - 99(2018)

2018

Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

原採認標準

142 3 Cardiovascular 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

143 3 Cardiovascular 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

144 3 Cardiovascular 心臟血管醫學

TFDA-01882 ASTM ASTM F746 - 04(2014)

2014

Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

原採認標準

145 3 Cardiovascular 心臟血管醫學

TFDA-01946 ISO ISO 8637-3:2018

Extracorporeal systems for blood purification - Part 3: Plasmafilters 109 年度新 增採認標準 146 3 Cardiovascular

心臟血管醫學

TFDA-01947 ISO ISO 81060-2:2018 /AMD 1:2020

2020

Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type - Second Edition

109 年度新 增採認標準 147 3 Cardiovascular

心臟血管醫學

TFDA-01948 ASTM ASTM F3320-18

Standard Guide for Coating Characterization of Drug Coated Balloons 109 年度新 增採認標準 148 3 Cardiovascular

心臟血管醫學

TFDA-01949 ISO ISO 5910:2018

Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices

109 年度新 增採認標準 149 3 Cardiovascular

心臟血管醫學

TFDA-01950 AAMI AAMI/ISO 14117:2019

2019

Active implantable medical devices—Electromagnetic

compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices.

109 年度新 增採認標準

150 3 Cardiovascular 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

109 年度新

增採認標準

15/121

151 3 Cardiovascular 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

109 年度新 增採認標準

152 3 Cardiovascular 心臟血管醫學

TFDA-01953 ISO ISO 14708-2:2019

Implants for surgery -- Active implantable medical devices -- Part 2:

Cardiac pacemakers

109 年度新 增採認標準 153 3 Cardiovascular

心臟血管醫學

TFDA-01954 ASTM ASTM F138 - 19

Standard Specification for Wrought 18 Chromium 14 Nickel 2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

109 年度新 增採認標準

154 3 Cardiovascular 心臟血管醫學

TFDA-01955 ASTM ASTM F2942 - 19

Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

109 年度新 增採認標準 155 3 Cardiovascular

心臟血管醫學

TFDA-01956 ISO ISO 15674:2016 /AMD 1:2020

2020

Cardiovascular implants and artificial organs - Hard-shell

cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

109 年度新 增採認標準

156 3 Cardiovascular 心臟血管醫學

TFDA-01957 ISO ISO 15675:2016 /AMD 1:2020

2020

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters

109 年度新 增採認標準 157 3 Cardiovascular

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)

109 年度新 增採認標準 158 3 Cardiovascular

心臟血管醫學

TFDA-01959 ISO ISO/TS 17137:2019

Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

109 年度新 增採認標準 159 4 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

160 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-00381 ISO ISO 6360-3: 2005

Dentistry -- Number coding system for rotary instruments -- Part 3:

Specific characteristics of burs and cutters

原採認標準

16/121

161 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-00382 ISO ISO 6360-4: 2004

Dentistry -- Number coding system for rotary instruments -- Part 4:

Specific characteristics of diamond instruments

原採認標準

162 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-00383 ISO ISO 6360-6: 2004

Dentistry -- Number coding system for rotary instruments -- Part 6:

Specific characteristics of abrasive instruments

原採認標準

163 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-00384 ISO ISO 6360-7: 2006

Dentistry – Number coding system for rotary instruments – Part 7:

Specific characteristics of mandrels and special instruments

原採認標準

164 4 Dental/ENT 牙科 學/耳鼻喉科學

TFDA-00385 ISO ISO 13397-1:1995

Periodontal curettes, dental scalers and excavators -- Part 1: General requirements

原採認標準

165 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-00387 ISO ISO 13397-3:1996

Periodontal curettes, dental scalers and excavators -- Part 3: Dental scalers -- H-type

原採認標準

166 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-00388 ISO ISO 13397-4:1997

Periodontal curettes, dental scalers and excavators -- Part 4: Dental excavators -- Discoid-type

原採認標準

167 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-00389 ISO ISO 15854:2005

Dentistry – Casting and baseplate waxes 原採認標準

168 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-00687 ISO ISO 6877:2006

Dentistry -- Root-canal obturating points 原採認標準

169 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-00690 ISO ISO 9917-1:2007

Dentistry -- Water-based cements -- Part 1: Powder/liquid acid-base cements

原採認標準

170 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-00873 ISO ISO 9168:2009

Dentistry -- Hose connectors for air driven dental handpieces 原採認標準

171 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01223 CEN EN 1639:2009

Dentistry. Medical devices for dentistry. Instruments 原採認標準

172 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01224 CEN EN 1640:2009

Dentistry. Medical devices for dentistry. Equipment 原採認標準

17/121

173 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01225 CEN EN 1641:2009

Dentistry. Medical devices for dentistry. Materials 原採認標準

174 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01226 CEN EN 1642:2011

Dentistry. Medical devices for dentistry. Dental implants 原採認標準

175 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01229 ISO ISO

13397-2:2005/Amd1:

2012

2012

Dentistry – Periodontal curettes, dental scalers and excavators – Part 2:Periodontal curettes of Gr-type

原採認標準

176 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01232 ISO ISO 21563:2013

Dentistry - Hydrocolloid impression materials - First Edition 原採認標準

177 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01233 ISO ISO 3107:2011

Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements - Fourth Edition

原採認標準

178 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01234 ISO ISO

6360-2:2004/Amd 1:2011

2011

Dentistry — Number coding system for rotary instruments — Part 2:

Shapes AMENDMENT 1 - Second Edition

原採認標準

179 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01235 ISO ISO 6876:2012

Dentistry - Root canal sealing materials - Third Edition 原採認標準

180 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01238 ADA ANSI/ADA 96-2012

ANSI/ADA Standard No. 96—Dental Water-based Cements: 2012 原採認標準

181 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01494 AAMI AAMI CI86:2017

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting

原採認標準

182 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01497 ISO ISO 10139-2:2016

Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use

原採認標準

183 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01498 ISO ISO 14801:2016

Dentistry - Implants - Dynamic loading test for endosseous dental implants 原採認標準

18/121

184 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01499 ISO ISO 22674:2016

Dentistry -- Metallic materials for fixed and removable restorations and appliances

原採認標準

185 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01500 ISO ISO

6360-1:2004/Cor1:20 07

2007

Dentistry — Number coding system for rotary instruments — Part 1:

General characteristics

原採認標準

186 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01502 ISO ISO 6874:2015

Dentistry — Polymer-based pit and fissure sealants 原採認標準

187 4 Dental/ENT 牙科 學/耳鼻喉科學

TFDA-01504 ISO ISO 7494-2:2015

Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems - Second Edition

原採認標準

188 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01789 ISO ISO 10139-1:2018

Dentistry - Soft lining materials for removable dentures - Part 1:Materials for short-term use

原採認標準

189 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01790 ISO ISO 10477:2018

Dentistry -- Polymer-based crown and bridge materials 原採認標準

190 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01791 ISO ISO 11137-3:2017

Sterilization of health care products —Radiation —Part 3:Guidance on dosimetric aspects

原採認標準

191 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01792 ISO ISO 14457:2017

Dentistry -- Handpieces and motors 原採認標準

192 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01793 ISO ISO 22112:2107

Dentistry - Artificial teeth for dental prostheses 原採認標準

193 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01794 ISO ISO 7491:2000

Dental materials—Determination of colour stability 原採認標準

194 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01795 ISO ISO 7494-1:2018

Dentistry -- Dental units -- Part 1: General requirements and test methods 原採認標準

19/121

195 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01796 ISO ISO 9917-2:2017

Dentistry - Water-based cements - Part 2: Resin-modified cements 原採認標準

196 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01883 ASA ASA S3.6-2018

American National Standard Specification for Audiometers 原採認標準

197 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01884 ISO ISO 6872:2015/AMD 1:2018

2018

Dentistry - Ceramic materials 原採認標準

198 4 Dental/ENT 牙科學/耳鼻喉科學

TFDA-01960 ISO ISO 9693:2019

Dentistry — Compatibility testing for metal-ceramic and ceramic-ceramic systems

109 年度新 增採認標準 199 4 Dental/ENT

牙科學/耳鼻喉科學

TFDA-01961 ASTM ASTM F1088-18

Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

109 年度新 增採認標準 200 4 Dental/ENT

牙科學/耳鼻喉科學

TFDA-01962 ISO ISO 7405:2018

Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry

109 年度新 增採認標準 201 4 Dental/ENT

牙科學/耳鼻喉科學

TFDA-01963 ISO ISO 17730:2014

Dentistry - Fluoride varnishes 109 年度新

增採認標準 202 4 Dental/ENT

牙科學/耳鼻喉科學

TFDA-01964 ISO ISO 4049:2019

Dentistry -- Polymer-based restorative materials 109 年度新 增採認標準 203 4 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

109 年度新 增採認標準 204 4 Dental/ENT

牙科學/耳鼻喉科學

TFDA-01966 ASA ASA S3.22-2014 (R2020)

2020

Specification of Hearing Aid Characteristics 109 年度新

增採認標準 205 4 Dental/ENT

牙科學/耳鼻喉科學

TFDA-01967 IEC IEC 60601-2-66:2019

Medical electrical equipment Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument system

109 年度新

增採認標準

20/121

206 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-00088 ISO ISO 10012:2003

Quality assurance requirements for measuring equipment Part 1:

Metrological confirmation system for measuring equipment

原採認標準

207 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-00439 CNS CNS14991

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

208 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-00440 CNS CNS14989

醫療器材風險管理 原採認標準

209 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-00441 CNS CNS14990

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

210 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01013 ISO ISO

14155:2011/Cor1:201 1

2011

Clinical investigation of medical devices for human subjects -- Good clinical practice

原採認標準

211 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01505 AAMI AAMI TIR69:2017

Risk management of radio-frequency wireless coexistence for medical devices and systems

原採認標準

212 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01507 EN EN 45502-1:2015

Implants for surgery - Active implantable medical devices - Part 1:

General requirements for safety, marking and for information to be provided by the manufacturer

原採認標準

213 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01509 IEC IEC TR 80002-1:2009

2009

Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software

原採認標準

21/121

214 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01510 ISO ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes

原採認標準

215 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01511 ISO ISO 15223-1:2016

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

原採認標準

216 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01512 ISO ISO 16061:2015

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)

原採認標準

217 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01513 ISO ISO 16142-1:2016

Medical devices-Recognized essential principles of safety and

performance of medical devices-Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

原採認標準

218 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01514 ISO ISO 16142-2:2017

Medical devices - recognized essential principles of safety and performance of medical devices - part 2: generalESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL

PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS

原採認標準

219 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01517 ISO ISO 80369-6:2016

Small-bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications

原採認標準

220 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01518 ISO ISO/TS

19218-1/Amd1:2013

2013

Medical devices - Hierarchical coding structure for adverse events - Part 1:

Event-type codes AMENDMENT 1 - First Edition

原採認標準

22/121

221 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01797 AAMI AAMI TIR36:2007

Validation of software for regulated processes 原採認標準

222 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01885 AAMI AAMI

HE75:2009(R2018)

2018

Human factors engineering - Design of medical devices 原採認標準

223 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01886 ISO IEC

80369-5:2016/COR 1:2017

2017

Small-bore connectors for liquids and gases in healthcare

applications—Part 5: Connectors for limb cuff inflation applications

原採認標準

224 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01968 ISO ISO 14971:2019

Medical devices -- Application of risk management to medical devices 109 年度新 增採認標準

225 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01969 ISO ISO/TR 24971:2020

Medical devices — Guidance on the application of ISO 14971 109 年度新 增採認標準

226 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01970 IEC IEC

62366-1:2015+AMD 1:2020

2020

Medical devices –Part 1: Application of usability engineering to medical devices

109 年度新 增採認標準

227 5 General I (QS/RM) 通用(品質管理系統/

風險管理)

TFDA-01971 ISO ISO

80369-3:2016/AMD 1:2019

2019

Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications

109 年度新

增採認標準

23/121

228 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00126 ISO ISO 8536-5:2004

Infusion Equipment for Medical Use - Part 5: Burette Type Infusion Sets 原採認標準

229 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00298 CNS CNS 14775

醫用面罩材料細菌過濾效率試驗法─使用金黃色葡萄球菌生物氣霧

Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

原採認標準

230 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00463 ISO ISO 11608-4:2006

Pen-injectors for medical use – Part 4:Requirements and test methods for electronic and electromechanical pen-injectors

原採認標準

231 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00464 ISO ISO 21649:2006

Needle-free injectors for medical use –Requirements and test methods 原採認標準

24/121

232 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00467 ISO ISO 8362-3:2001

Injection containers and accessories -- Part 3: Aluminium caps for injection vials

原採認標準

233 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00471 ISO ISO 8362-7:2006

Injection containers and accessories –Part 7: Injection caps made of aluminiumplastics combinations without overlapping plastics part

原採認標準

234 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00478 CNS CNS 4397

脫脂紗布 原採認標準

235 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00589 CNS CNS 15036-1

用於人類血液和血液成品塑膠可折疊之容器－第１部：慣用容器（血

袋）

原採認標準

25/121

236 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00590 CNS CNS 13460:

電刀裝置 原採認標準

237 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00592 CNS CNS 14624-2

醫療用輸液設備─第二部份：點滴瓶瓶塞 原採認標準

238 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00593 CNS CNS 14624-3

醫療用輸液設備─第三部份：點滴瓶鋁蓋 原採認標準

239 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00599 ISO ISO 15883-2:2006

Washer-disinfectors -- Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.

原採認標準

26/121

240 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00600 ISO ISO 15883-3:2006

Washer-disinfectors -- Part 3: Requirements and tests for

washer-disinfectors employing thermal disinfection for human waste containers

原採認標準

241 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00601 ISO ISO/TS 15883-5:2005

2005

Washer-disinfectors -- Part 5: Test soils and methods for demonstrating cleaning efficacy

原採認標準

242 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00784 CNS CNS 15042

間歇性測定患者體溫之紅外線體溫計 原採認標準

243 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00785 CNS CNS 15043

間歇性測定患者體溫之電子式體溫計 原採認標準

27/121

244 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00786 CNS CNS 15044

體溫計探針護套 原採認標準

245 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00787 CNS CNS 15212-3

電子體溫計－第 3 部：具最大值（非預測性與預測性）裝置之小型電

子體溫計的性能

原採認標準

246 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00788 CNS CNS 15212-4

電子體溫計－第 4 部：用於連續量測之電子體溫計的性能 原採認標準

247 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00789 CNS CNS 15212-5

電子體溫計－第 5 部：紅外線耳溫計（具最大值裝置）的性能 原採認標準

28/121

248 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00790 CNS CNS 15226

單次使用之無菌橡膠手套－規格 原採認標準

249 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00791 CNS CNS 15227

單次使用之醫用檢驗手套－第 1 部：以乳膠或橡膠溶液製成之手套規

格

原採認標準

250 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00917 ISO ISO 8536-2:2010

Infusion equipment for medical use -- Part 2: Closures for infusion bottles 原採認標準

251 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00918 ISO ISO 8536-3:2009

Infusion equipment for medical use -- Part 3: Aluminium caps for infusion bottles

原採認標準

29/121

252 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00920 ISO ISO 8536-7:2009

Infusion equipment for medical use -- Part 7: Caps made of aluminium-plastics combinations for infusion bottles

原採認標準

253 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00928 ISO ISO 8362-6:2010

Injection containers and accessories -- Part 6: Caps made of aluminium-plastics combinations for injection vials

原採認標準

254 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-00988 OIML OIML R115:1995

Clinical electrical thermometers with maximum device 原採認標準

255 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-01257 AAMI ANSI/AAMI BF7:2012

2012

Blood transfusion micro-filters 原採認標準

30/121

256 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-01259 AAMI AAMI PB70:2012

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

原採認標準

257 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-01272 ASTM ASTM

F1671/F1671M-13

2013

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

原採認標準

258 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-01275 ASTM ASTM

F2119-07(2013)

2013

Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

原採認標準

259 6 General Plastic Surgery/General Hospital 一般及整 形外科手術/一般醫 院及個人使用裝置

TFDA-01276 ASTM ASTM

F2172-02/(R)2011

2011

Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers

原採認標準