Health Technology Medical Equipment (General) Standards

Our company conducts the testing, auditing and certification of all the following standards.
The standards mentioned are as follows;

TS EN ISO 10993-2 Biological evaluation of medical devices - Part 2: Animal health characteristics

TS EN 60601-1 Electrical medical equipment - Part 1: General rules for basic safety and required performance

TS EN 60601-1-8 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems

TS EN 301489-29 V1.1.1 Electromagnetic compatibility and radiospectrum issues (erm) Electromagnetic compatibility (emu) standard for radio equipment; Part 29: Special requirements for medical data service devices (meds) operating in the 401 mhz to 402 mhz and 405 mhz to 406 mhz bands

TS EN ISO 14971 Medical devices - Applying risk management to medical devices (ISO 14971: 2007; Revised edition 2007-10-01)

TS EN 60601-1-6Electrical medical equipment - Part 1-6: General rules for basic safety and required performance - Auxiliary standard: Ease of use

Electrical medical equipment - Part 60601-2: Particular requirements for the essential safety and required performance of external pacemakers with internal power supply (IEC 31-1-2: 31: 60601)

60601-2-52: 2010 / AC: 2011 Electrical medical equipment - Part 2-52: Specific requirements for basic safety and necessary performance of patient beds

TS EN 80001-1: 2011 Application of risk management for IT networks for medical devices - Part 1: Roles, responsibilities and activities

TS EN 60601-2-4 Electrical medical equipment - Part 2-4: Specific features for basic safety and significant performance of heart defibrillators

TS EN 60601-2-46 Medical electrical equipment - Part 2 - 46: Specific features for basic safety and significant performance of operating tables

TS EN 1041 + A1 Information supplied by the manufacturer with medical devices

TS EN 1041 + A1 Information provided by medical device manufacturers

60601-1-8 / A1 / AC Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems

TS EN 13718-1 Medical instruments and equipment - Air ambulances - Part 1: Specifications of medical devices used in air ambulances 24.12.2014 11.040.01

tst EN 60601-1-9 Electrical medical equipment - Part 1-9: General specifications for basic safety and performance required - Supplementary standard: Specification for environmentally conscious design (IEC 60601-1-9: 2007)

Electrical medical equipment - Part 60601-1: General requirements for basic safety and performance - Auxiliary standard: Specifications for environmentally conscious design (IEC 9-1-1: 9 / A60601: 1 )

tst EN 60601-1-8 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems (IEC 60601-1-) 8: 2006)

Electrical medical equipment - Part 60601-1: General rules for basic safety and required performance - Supplementary standard: General specifications, tests and guidance for electrical medical equipment and warning systems in electrical medical systems (IEC 8) -1-1: 8 / A60601: 1)

TS EN ISO 19054Supportive rail systems for medical equipment

TS EN ISO 19106 Geographical information-Profiles 1

TSE IEC / TR 60825-8 Safety of laser products - Section 8: Guidelines for the safe use of laser devices used in medicine

TS EN ISO 18777 Breathing equipment - Newborn monitors - Specific features

TS EN ISO 18777 Portable liquid oxygen systems for medical use - Specific features

Electrical medical equipment - Part 60601-2: Particular requirements regarding the basic safety and required performance of luminaires used in surgical interventions and diagnostics: TS EN 41-11-2 / A41

TS EN ISO 23907 Protection against cutting injuries - Properties and test methods - Part 3: Cutting containers

Electrical medical equipment - Part 60601-2: Particular requirements regarding the basic safety and required performance of surgical luminaires used in surgical interventions and diagnostics TS EN 41-2009-11: 2 / A41

TS EN ISO 16061 Instruments used with inactive surgical implants - General features

TS EN 60601-2-26 Electrical medical devices - Part 2-26: Specific requirements for the essential safety and required performance of electroencephalography devices

TS EN 60601-2-25 Medical electrical equipment - Part 2-25: Specific requirements for essential safety and required performance of electrocardiographs

tst EN 60601-2-26 Electrical medical devices - Part 2-26: Specific requirements for the essential safety and required performance of electroencephalography devices (IEC 60601-2-26: 2012)

tst EN 60601-2-25 Medical electrical equipment - Part 2-25: Specific requirements for the essential safety and required performance of electrocardiographs (IEC 60601-2-25: 2011)

tst EN 60601-2-39 Electrical medical devices - Part 2-39: Particular requirements for the safety of peritoneal dialysis devices (IEC 60601-2-39: 2007)

Electrical medical devices - Part 60601-2: Particular features for the safety of peritoneal dialysis devices

Electrical medical devices - Part 60601-2: Particular features for the safety of peritoneal dialysis devices TS EN 39-11-2 / tst A39

TS EN ISO 19054 / A1 Supporting rail systems for medical equipment

tst EN ISO 16061 Instruments used with inactive surgical implants - General features

TS EN 60601-2-41 Electrical medical equipment - Part 2-41: Specific requirements for the basic safety and required performance of lighting fixtures for surgical interventions and diagnostics