最新消息
目前世界上所認定醫療電子器材相關電性安全測試為 IEC 60601-1，IEC 60601-1 涵蓋所有的一般規定，包括危害清單及風險性的承受限制。
IEC 60601-1-X 並行標準系列規定主要目標為電氣醫療器材系統、電磁相容性、X光防護等，並必須與 IEC 60601-1 同時適用。
IEC 60601-2-XX 系列規定適用於特定醫療器材，並必須同時適用 IEC 60601-1，也可適用 IEC 60601-1-X標準。
而目前醫療電子產品常見的測試為：
1.SAFETY【IEC 60601-1-1】：Safety Requirements for Medical Electrical Systems (06/92), Am.1 (11/95), Ed.2 (12/00).
2.EMC【IEC 60601-1-2】：Electromagnetic Compatibility - Requirements and Tests (04/93), Ed.2 (09/01), Am.1 (09/04), Ed. 2.1 (11/04).
此外各國也以此標準作為依據進行標準性調和，例如：
美國：UL 60601-1 Ed.1 (4/25/2003)
日本:JSA JIS T0601-1 (12/27/1999)
歐盟：EN 60601-1 (8/1990) + Am.1 (5/1993) + Am.2 (6/1995) + Am.11 (5/1993) + Am.12 (5/1993) + Am.13 (1/1996)
加拿大：CSA C22.2 No. 601.1-M90 (11/2003)
台灣：CNS 14509
目前 IEC 60601-1 為第二版：
IEC 60601-1 Ed.2 (12/98) Medical Electrical Equipment = IEC 601-1 (1988) + Am 1 (11/91) + Am. 2 (03/95).
第三版已經進入 FDIS 版階段，預計 2006年發行，緩衝期：預估 2-5 年，還需視各別產品特別規範(Part 2)之改版進度而定。
適用標準清單：
| IEC 60601-1-1 | Safety Requirements for Medical Electrical Systems (06/92), Am.1 (11/95), Ed.2 (12/00). |
| IEC 60601-1-2 | Electromagnetic Compatibility - Requirements and Tests (04/93), Ed.2 (09/01), Am.1 (09/04), Ed. 2.1 (11/04). |
| IEC 60601-1-3 | Gen. Requirements for Radiation Protection in Diagnostic X-ray Equipment (07/94). |
| IEC 60601-1-4 | Programmable Electrical Medical Systems (05/96), Am.1 (10/99), Ed.1.1 Consolidated (04/00). |
| IEC 60601-1-5 | Image quality and dose for X-ray equipment (Project). |
| IEC 60601-1-6 | Analysis, test and validation of human factors compatibility Ed.1 (06/04). |
| IEC 60601-1-8 | General requirements and guidelines for the application of alarms in Medical Electrical Equipment (08/03). |
| IEC 60601-1-9 | Requirements for the reduction of environmental impacts (Project). |
| IEC 60601-1-10 | Process requirements for the development of therapeutic closed-loop controllers (Project). |
| IEC 60601-2-2 | High Frequency Surgical Equipment Ed. 3 (09/98) Ed.4 (Project). [AAMI HF18-331]. |
| IEC 60601-2-3 | Short-Wave Therapy Equipment Ed. 2 (06/91), Am.1 (09/98) Ed.2 (Project). |
| IEC 60601-2-4 | Cardiac Defibrillators and Cardiac Defibrillator-Monitors (01/83), Ed.2 (08/02), |
| IEC 60601-2-5 | Ultrasonic Therapy Equipment (01/84), Ed.2 (07/00) |
| IEC 60601-2-6 | Microwave Therapy Equipment (01/84). |
| IEC 60601-2-10 | Nerve and Muscle Stimulators (12/87), Am.1 (09/01), Corrigendum (02/02). |
| IEC 60601-2-19 | Baby Incubators (12/90), Am.1 (10/96). [AAMI II36-331]. |
| IEC 60601-2-20 | Transport Incubators (12/90), Am.1 (10/96). [AAMI II51-331]. |
| IEC 60601-2-21 | Infant Radiant Warmers (02/94), Am.1 (10/96) |
| IEC 60601-2-22 | Diagnostic and Therapeutic Laser Equipment Ed. 2 (11/95), Ed. 3 (Project). |
| IEC 60601-2-23 | Transcutaneous Partial Pressure Monitoring Equipment (09/93), Including essential performance Ed. 2 (12/99). |
| IEC 60601-2-38 | Electrically Operated Hospital Beds (10/96), Am.1 (12/99), (Next Ed. will be IEC 60601-2-52). |
