NEWS
HOME > News
NEWS
2014-08-25
IEC60601-2 Standard description
IEC60601-2 Standard description:
At present, the world recognized medical electronic equipment related to electrical safety testing for IEC 60601-1, IEC 60601-1 covers all 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, etc., and must be applied simultaneously with IEC 60601-1.
IEC 60601-2-XX series of specific provisions applicable to medical devices 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). .
The countries are also standard as the basis for this standard of reconciliation, 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:
IEC 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, a buffer period: estimated 2-5 years, depending on individual needs special specification products (Part 2) of the revised schedule may be.
If you want to medical equipment related to electrical safety tests are closer to an understanding, can go to the Foundation of Taiwan's electronics test center inquiries.
At present, the world recognized medical electronic equipment related to electrical safety testing for IEC 60601-1, IEC 60601-1 covers all 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, etc., and must be applied simultaneously with IEC 60601-1.
IEC 60601-2-XX series of specific provisions applicable to medical devices 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). .
The countries are also standard as the basis for this standard of reconciliation, 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:
IEC 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, a buffer period: estimated 2-5 years, depending on individual needs special specification products (Part 2) of the revised schedule may be.
If you want to medical equipment related to electrical safety tests are closer to an understanding, can go to the Foundation of Taiwan's electronics test center inquiries.
| 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). | |||
