附表、醫療器材品項及其對應臨床前測試基準或標準

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附表、醫療器材品項及其對應臨床前測試基準或標準

110年5月1日更新

A.品項名稱 Device

name

B.分級分類代碼 Classification

number

C.對應臨床前 測試基準 Guidance for

pre-clinical testing

D.對應標準 1.功能性(垂直)標準

Essential performance (vertical) standards

2.共通安全性(水平)標準

General Safety (horizontal) standards

紅外線耳溫槍

(Infrared ear thermometer)

J.2910 紅外線耳溫槍

臨床前測試基準

1. ISO 80601-2-56:2017/Amd 1: 2018 Medical electrical equipment - Part 2- 56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement；或 2. ASTM E1965 - 98(2009) Standard

Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature；或

3.中華民國國家標準 CNS 15042 間歇性測定患者體溫之紅外線體溫計 (2007)

1. EC 60601-1:2005+Amd 1:2012 Medical Electrical Equipment – Part 1: General Requirements for basic Safety and Essential Performance；及

2. IEC 60601-1-2:2014 Medical electrical Equipment - Part 1-2: General requirements for basic safety and ssential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests；及 3. 產品與人體接觸部位(如探頭、護套等)：

ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 紅外線額溫

槍(Infrared Forehead thermometer)

J.2910 無 1. ISO 80601-2-56:2017/Amd 1: 2018 Medical electrical equipment - Part 2- 56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement；或 2. ASTM E1965 - 98(2009)

Standard Specification for Infrared

1. IEC 60601-1:2005+Amd 1:2012 Medical Electrical Equipment – Part 1: General Requirements for basic Safety and Essential Performance；及

2. IEC 60601-1-2:2014 Medical electrical Equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic

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Thermometers for Intermittent Determination of Patient Temperature；或

3.中華民國國家標準 CNS 15042 間歇性測定患者體溫之紅外線體溫計 (2007)

disturbances – Requirements and tests；及 3. 產品與人體接觸部位(如探頭、護套等)：

ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 電子體溫計

(Clinical electronic thermometer)

J.2910 臨床電子體溫

計臨床前測試基準

1. ASTM E 1112 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature (2018)；或

2. ISO 80601-2-56:2017/Amd 1: 2018 Medical electrical equipment - Part 2- 56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement；或 3.中華民國國家標準 CNS 15043 間歇

性測定患者體溫之電子式體溫計 (2007)

2. IEC 60601-1-2:2014 Medical electrical Equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests；及 3. 產品與人體接觸部位(如探頭、護套等)：

ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 外科用覆蓋

巾 (Surgical drape)

I.4370 外科用覆蓋巾

臨床前測試基準

EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

1. ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process；

及

2. 進行滅菌確效 (Sterilization validation) (見備註)確保 SAL (Sterility assurance level)小於10^-6；及

3. 若為重複使用產品：ANSI/AAMI ST65 Processing of reusable surgical textiles for use in health care facilities (2008/R2018), section 6-Laundry processing

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recommendations and section 7-Inspection, testing, and maintenance of laundered textiles

外科手術衣 (surgical gowns)

I.4040 無 EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

1. ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process；

及

2. 進行滅菌確效 (Sterilization validation) (見備註)確保 SAL (Sterility assurance level)小於10^-6；及

3. 若為重複使用產品：ANSI/AAMI ST65 Processing of reusable surgical textiles for use in health care facilities (2008/R2018), section 6-Laundry processing

recommendations and section 7-Inspection, testing, and maintenance of laundered textiles

外科手術燈 (Surgical lamp)

I.4580 外科手術燈臨

床前測試基準

IEC 60601-2-41:2009+Amd 1:

2013Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

2. IEC 60601-1-2:2014 Medical electrical Equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances –Requirements and tests 靜電器(電位

治療器) (Static Electric

O.0001 靜電器(電位治

療器)臨床前測試基準

JIS T 2003:2018 Electric therapy apparatus for home use

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Therapy Apparatus)

2. IEC 60601-1-2:2014 Medical electrical Equipment - Part 1-2: General

requirements for basic safety and essential performance – Collateral Standard:

Electromagnetic disturbances – Requirements and tests

紅外線燈(治療器) (Infrared Lamp (therapy apparatus))

O.5500 紅外線燈(治療

器) 臨床前測試基準

JIS T 0601-2-203:2015 Medical electrical equipment - Part 2-203: Particular

requirements for the basic safety and essential performance of infrared therapy equipment

2. IEC 60601-1-2:2014 Medical electrical Equipment - Part 1-2: General

requirements for basic safety and essential performance – Collateral Standard:

Electromagnetic disturbances – Requirements and tests

備註：滅菌確效需視滅菌方法，以對應之國際公定標準進行—

1. EO 滅菌- ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices

2. 輻射滅菌- ISO 11137-1:2015 Sterilization of health care products- Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 及 ISO 11137-2:2015 Sterilization of health care products- Radiation - Part 2: Establishing the sterilization dose 及 ISO 11137-3:2017 Sterilization of health care products- Radiation - Part 3Guidance on dosimetric aspects

3. 濕熱滅菌- ISO 17665-1:2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices