Source: http://ideaenvypro.com/centum/our-sectors/medical/
Timestamp: 2018-05-23 05:22:32
Document Index: 331043456

Matched Legal Cases: ['art1', 'art 1', 'art 2', 'art 4', 'art 1', 'art 8']

Medical – Centum
ISO 13485 Quality systems – Medical devices – Particular requirements for the application of ISO 9001.
IEC CISPR11 / EN55011 Industrial, scientific & medical radiofrequency equipment – electromagnetic disturbance characteristics – limits & methods of measurements.
IEC 62304 / prEN 624 Medical device software – Software life-cycle processes.
IEC / EN 60601-1-4 Medical Equipment – Part1: General requirements for safety collateral standard 4: Programmable electrical medical systems.
IEC 60068 series Environment Tests.
ISO 14971 Medical Devices – Application of risk management to medical devices.
IEC 60825-1 Safety of laser products – Part 1: Equipment classification and requirements.
IEC60825-2 Safety of laser products – Part 2: Safety of optical fiber communication systems (OFCS).
IEC 60664 Insulation requirements (Over Voltage Category III, pollution degree 2).
IEC 61000-4-5 level 4 Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement techniques – Surge immunity test.
IEC 60364-7-710 Requirements for special installations or locations Medical locations.
IEC 61326-2-4 Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. Test configurations, operational conditions and performance criteria for insulation monitoring devices.
IEC 60601-1 Medical Equipment – Part 1: general requirements for safety
IEC 61557-8 Electrical safety in low voltage distribution systems up to 1 000 V AC and 1 500 V DC – Equipment for testing, measuring or monitoring of protective measures – Part 8: Insulation monitoring devices for IT systems.