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Testing Laboratory of SERTIKA is accredited by National Accreditation Bureau according to LST EN ISO/IEC 17025:2005 (General requirements for the competence of testing and calibration laboratories) since 1997. Our test reports are generally recognized by all states of European Union. SERTIKA works according valid international standards see our accreditation scope below.

 

 

UAB „SERTIKA" TEST LABORATORIE ACCREDITATION FIELD

 

 

LST EN / IEC 60601-1:2005

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

 

Scope: Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.

 

 

LST EN / IEC 60601-1-8:2006

Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

 

Scope: Specifies basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems.

 

 

LST EN / IEC 60601-2-24:2012

Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

 

Scope: IEC 60601-2-24:2012 applies to the basic safety and essential performance of infusion pumps and volumetric infusion controllers. This standard applies to administration sets insofar as their characteristics influence the basic safety or essential performance of infusion pumps and volumetric infusion controllers. However this standard does not specify requirements or tests for other aspects of administration sets. This particular standard specifies the requirements for enteral nutrition pumps, infusion pumps, infusion pumps for ambulatory use, syringe or container pumps, volumetric infusion controllers and volumetric infusion pumps. This particular standard does not apply to the following: devices specifically intended for diagnostic or similar use; devices for extracorporeal circulation of blood; implantable devices; equipment specifically intended for diagnostic use within urodynamics; equipment specifically intended for diagnostic use within male impotence testing; and devices covered by ISO 28620. This second edition cancels and replaces the first edition of IEC 60601-2-24. This edition constitutes a technical revision according to IEC 60601-1:2005+A1:2012 with new clause numbering, including usability and alarms.

 

 

LST EN / IEC 60601-2-52:2009

Medical electrical equipment -- Part 2-52: Particular requirements for basic safety and essential performance of medical beds

 

Scope: EC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.

 

 

LST EN / EN 12182:2012

Assistive products for persons with disability - General requirements and test methods

 

Scope: This European Standard specifies general requirements and test methods for assistive products for persons with a disability, which are medical devices according to the definition laid down in the EU Directive 93/42/EEC. This European Standard does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user. Where other European Standards exist for particular types of assistive products then those standards apply. However, some of the requirements of this standard may still apply and may be considered in addition to those in other European standards. NOTE Not all the items listed in EN ISO 9999 are medical devices. Contracting parties may wish to consider if this standard or parts of this standard can be used for assistive products which are not medical devices as defined in the EU Directive 93/42/EEC

 

 

LST EN / ISO 6875:2011

Dentistry - Patient chair

 

Scope: ISO 6875:2011 is applicable to all patient chairs, regardless of their construction, and regardless of whether they are operated manually, electrically or by other means, or as a combination of these. ISO 6875:2011 specifies requirements, test methods, manufacturer's information, marking and packaging.

 

 

LST EN / IEC 60950-1:2005

Information technology equipment - Safety - Part 1: General requirements

 

Scope: Applicable to mains-powered or battery-powered information technology equipment, including electrical business equipment and associated equipment, with a RATED VOLTAGE not exceeding 600 V. Also applicable are components and subassemblies intended for incorporation in information technology equipment. It is not expected that such components and subassemblies comply with every aspect of the standard, provided that the complete information technology equipment, incorporating such components and subassemblies, does comply. The contents of the corrigenda of August 2006 and August 2013 have been included in this copy.

 

 

LST EN / IEC 61010-1:2010

Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 1: General requirements

 

Scope: IEC 61010-1:2010 specifies general safety requirements for the following types of electrical equipment and their accessories, wherever they are intended to be used. a) Electrical test and measurement equipment b) Electrical industrial process-control equipment c) Electrical laboratory equipment This third edition cancels and replaces the second edition published in 2001. It constitutes a technical revision. This edition includes the following significant changes from the second edition, as well as numerous other changes. - The scope of the standard has been expanded to include all locations where these products may be used, so that both professional and non-professional versions of these products are within the scope. - The requirements for testing and measuring circuits (in various subclauses and the entirety of Clause 16) have been removed and included in a particular standard IEC 61010-2-030. - Insulation requirements (6.7) have been completely rewritten. - Additional requirements for protection against mechanical HAZARDS (Clause 7) have been included. - Surface temperature limits (Clause 10) have been modified to conform to the limits of EN 563. - Radiation requirements (Clause 12) have been modified, and take into account a distinction between intended emission and unintended emission. - Requirements for reasonably foreseeable misuse and ergonomic aspects have been added (Clause 16). - A new clause (Clause 17) has been added to deal with HAZARDS and environments not covered by the standard, along with a new informative annex (Annex J) dealing with RISK assessment. - A new informative annex (Annex E) addresses methods of reducing the POLLUTION DEGREE of a micro-environment. - Requirements for the qualification of coatings for protection against POLLUTION have been added (Annex H). - A new informative annex (Annex I) has been added to further explain how to determine the WORKING VOLTAGE of a MAINS CIRCUIT. It has the status of a group safety publication, as specified in IEC Guide 104. The contents of the corrigendum 1 of May 2011, the interpretation sheet 1 of February 2013 and the corrigendum 2 of October 2013 have been included in this copy.

 

 

LST EN / ISO 9170-1:2008

Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum

 

Scope: ISO 9170-1:2008 applies to: terminal units intended for use in medical gas pipeline systems in accordance with ISO 7396-1, for use with the following medical gases: oxygen, nitrous oxide; medical air; carbon dioxide; oxygen/nitrous oxide mixture [50 %/50 % (by volume)]; terminal units intended for use in medical gas pipeline systems in accordance with ISO 7396-1, for use with the following gases and services: oxygen-enriched air; air for driving surgical tools; nitrogen for driving surgical tools; vacuum. It is intended especially to ensure the gas-specific assembly of terminal units and to prevent their interchange between different gases and services. ISO 9170-1:2008 specifies requirements for terminal units for supply and disposal of nitrogen or air for driving surgical tools and requirements for probes intended to be connected to the gas-specific connection point which is part of the terminal unit.

 

 

LST EN / ISO 11197:2016

Medical supply units

 

Scope: IEC 60601-1:2005+A1:2012, 1.1 is replaced by: ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment. ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit. Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4). NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.

 

 

LST EN / IEC 60335-1:2010

Household and similar electrical appliances - Safety -- Part 1: General requirements

 

Scope: IEC 60335-1:2010 deals with the safety of electrical appliances for household and similar purposes, their rated voltage being not more than 250 V for single-phase appliances and 480 V for other appliances. Battery-operated appliances and other d.c. supplied appliances are within the scope of this standard. Appliances not intended for normal household use but which nevertheless may be a source of danger to the public, such as appliances intended to be used by laymen in shops, in light industry and on farms, are within the scope of this standard. Examples of such appliances are catering equipment, cleaning appliances for commercial use, and appliances for hairdressers. The attention of National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 12 months or later than 36 months from the date of publication. The contents of the corrigenda of July 2010 and April 2011 have been included in this copy.

 

 

LST EN / IEC 62368-1:2014

Audio/video, information and communication technology equipment - Part 1: Safety requirements

 

Scope: IEC 62368-1:2014 deals with the safety of electrical and electronic equipment within the field of audio, video, information and communication technology, and business and office machines with a rated voltage not exceeding 600 V. This standard does not include requirements for performance or functional characteristics of equipment. Examples of equipment within the scope of this standard are given in Annex A. A rated voltage of 600 V is considered to include equipment rated at 400/690 V. This part of IEC 62368 is also applicable to: components and subassemblies intended for incorporation in this equipment. Such components and subassemblies need not comply with every requirement of the standard, provided that the complete equipment, incorporating such components and subassemblies, does comply; external power supply units intended to supply other equipment within the scope of this part of IEC 62368 and accessories intended to be used with equipment within the scope of this part of IEC 62368. This part of IEC 62368 does not apply to power supply systems which are not an integral part of the equipment, such as motor-generator sets, battery backup systems and distribution transformers. This part of IEC 62328 specifies safeguards for ordinary persons, instructed persons, and skilled persons. Additional requirements may apply for equipment that is clearly designed or intended for use by children or specifically attractive to children. This second edition cancels and replaces the first edition published in 2010. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - addition of requirements for LEDs; - new requirements for wall and ceiling mounting means; - addition of acoustic shock requirements for personal music players; - revision of the battery requirements, including new requirements for coin/button cell batteries and revision of the burn requirements. Key words: Audio/Video, Safeguards, Information, Communication

 

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