NEWS
The world recognized medical electronic equipment related to the electrical safety testing for IEC 60601-1, IEC 60601-1 covers all of the general provisions, including a list of hazards and risk tolerance limit.
Parallel standard IEC 60601-1-X series provides the main objectives for electrical medical equipment systems, electromagnetic compatibility, X-ray protection, and must apply with IEC 60601-1.
IEC 60601-2-XX series of provisions applicable to a particular medical equipment, and must also apply IEC 60601-1, IEC 60601-1-X is also applicable standards.
The current common test medical electronic products:
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).
Further countries are also standard as the basis for this standard Harmonic, such as:
USA：UL 60601-1 Ed.1 (4/25/2003)
Japan:JSA JIS T0601-1 (12/27/1999)
EU：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)Canada：CSA C22.2 No. 601.1-M90 (11/2003)
Taiwan：CNS 14509
At present, for the second edition of IEC 60601-1:
EC 60601-1 Ed.2 (12/98) Medical Electrical Equipment = IEC 601-1 (1988) + Am 1 (11/91) + Am. 2 (03/95).
FDIS version of the third edition has entered the stage, is expected to release in 2006, buffer period: estimated 2-5 years, depending on the individual needs special specification products (Part 2) depending on the progress of the revision.
Applicable standards list:
| 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). |
