CE Certification for Pressure Vessels

According to Pressure Equipment Directive, the term ‘pressure equipment’ includes pressure vessels, safety devices, plumbing pipes and elements attached to pressure parts such as tubules, couplings and flanges.

Importing and manufacturing companies should know whether a notified body is to be involved or the pressure equipment is to be evaluated directly. The PED classifies pressure equipment into 4 categories, on the basis of product characteristics like, the maximum permissible diameter, pressure and volume of the pressure equipment and the state of the desired material content.

In case different categories of pressure equipment are installed in an integrated and functional unit, the pressure equipment of the highest category determines the entire installation. Every module specifies an eligibility process to be followed and the appropriate module is applied according to the applicable category.

By putting the CE Mark on the pressure equipment, the importer or the manufacturer discloses that his product meets the essential requirements of the 2014 / 68 / EU Pressure Equipment Directive. Only those pressure receptacles that are CE marked are free to operate within the European Economic Area.

Devices and parts that contribute in the resistance of pressurized containers are mostly unalloyed aluminum, unalloyed quality steel, or aging hardened aluminum alloys. The products that are not covered by 2014/68/EU are:

  • Pipelines for the transport of any fluid or substance to a facility by land or sea
  • Aerosol dispensers (Directive 75/324/EEC)
  • Pressure equipment consisting of a flexible body (e.g tires and airbags)
  • Bottles or cans used for carbonated drinks
  • Blast furnaces
  • Radiators and pipes in hot water heating
  • Simple pressure vessels (directive 2014/29/EU)

Comprehensive CE Mark Certification for pressure equipment is done by competent authorities in accordance with this regulation. In addition to the CE certification, product classification to determine the relevant requirements, regulatory risk analysis, product conformity testing based on European harmonized standards, selection and guidance for the notified body if necessary, preparation and evaluation of the technical file, preparation and control of user instructions and Services for verifying the European Union declaration of conformity are also provided.

The Pressure Equipment Directive (PED) contains legal obligations for distributors, manufacturers and importers. A technical dossier needs to be prepared by manufacturers for pressure equipment and they need to carry out the conformity assessment process. The EU then declares the conformity of the concerned pressure equipment to the applicable requirements and affix the CE mark on the product.

Safety assessment and product testing based on European harmonized standards has to be carried out while conducting conformity assessment.

We at Eurotech provide CE Certification Services of pressure vessels. With the help of our services, enterprises are able to produce more efficient, high performing and quality products in a fast, safe and uninterrupted manner.

CE Certification of pressure vessels are is only one of the certifications provided by our organization. Many other certification services are also available.

For more information, contact trg@eurotechworld.net or fill out the form below to get your QUOTE today.

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CE Certification for Luminaries

The CE marked luminaires ensure safety and prove their compliance with the relevant legal regulations.

There are many independent laboratories carrying out independent tests to support the declaration of conformity required by manufacturers to affix CE Mark on lighting fixtures. It is a legal obligation on the part of the importers or manufacturers outside of the European Union countries to take care of the fittings to be offered to consumers.

The declaration of conformity to the following directives is essential for the manufacturers for CE marking their luminaries:

  • Low Voltage Directive - 2014/35/EU
  • Electromagnetic Compatibility Directive 2014/30/EU
  • Radio Equipment Directive 2014/53/EU
  • Energy Related Products Directive 2009/125/EC
  • Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU

 

The following legal regulations were issued based on these directives:

  • Implementing Regulation on Environmentally Friendly Design of Energy Related Products
  • Regulation on Electrical Equipment Designed for Specific Voltage Limits (Low Voltage Regulation)
  • Implementing Regulation on Wireless and Telecommunication Terminal Equipment
  • Implementing Regulation on Classification, Packaging and Labeling of Dangerous Substances and Preparations
  • Electromagnetic Compatibility Regulation

A number of tests required by the luminaries to be affixed with the CE mark, can be carried out by the manufacturers on their own or they can avail the testing services of advanced laboratories. Once the required tests are completed, the manufacturer has to keep the test reports in the technical file.

There are other relevant regulations that may also be applicable in the CE marking process and may require compliance. Example, general product safety regulation, REACH regulation, waste management, batteries, energy labeling.

In many cases, harmonized European standards are adequate to comply with the requirements of legal regulations and offer the easiest means to meet the requirements of manufacturers.

Deviation from standards, like failure to meet full performance requirements, have to be explained in detail in the declaration of conformity and technical dossier as to why the standard is not fully implemented. Such deviations may cause problems with government agencies as it can lead to different interpretations depending on who makes the comment, the solution proposal & the intended use of the product. However, manufacturers should of course only provide suitable products in the market and document that the products meet the basic requirements.

According to the types of commonly used lighting fixtures, the main standards for CE marking conformity are:

  • Regarding low voltage,
    • TS EN 60598 Lighting fixtures
    • TS EN 62493 Inspection of illumination equipment for people exposed to electromagnetic fields
    • TS EN 61347 Lamp control system
    • TS EN 60432 Lamps - Incandescent filament - Safety regulations
  • Regarding electromagnetic compatibility,
    • TS EN 55015 Limit measurement methods and values of radio distortion characteristics of electrical lighting and similar equipment
    • TS EN 61547 General lighting devices - EMC immunity rules
    • TS EN 61000 Electromagnetic compatibility (EMC)
  • Regarding energy,
    • TS EN 62722 Fixture performance
    • TS EN IEC 62442 Energy performance of the lamp controller
  • Regarding RoHS,
    • TS EN IEC 63000 Technical documentation for the evaluation of electronic and electrical products according to the limitation of hazardous substances

CE Certification of luminaries is only one of the services provided by Eurotech Assessment and Certification Services Pvt. Ltd. among many others. Many other certification services like CE Certification for medical devices, electrical/electronics, construction, pressure equipment, RoHS etc. are also available. We also provide testing services for your electrical/electronic products through our sister concern.

For more information, contact trg@eurotechworld.net or fill out the form below to get your QUOTE for CE Certification today.

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CE Certification for Bulbs

CE Mark on the bulbs that are provided to consumers includes various requirements like RoHS, electromagnetic compatibility (EMC), Eco-Design and safety. Though the EMC, RoHS and security requirements have been addressed intensively for years, Eco-Design requirement has been added to these recently.

These 4 requirements are imperative for all bulbs regardless of where they are used. The products covered under Eco-Design must bear the CE mark and manufacturers need to declare their conformity within the framework of the Energy Related Products Directive 2009/125/ EC.

Energy efficiency, safety & other legal requirements have been introduced for lighting products that the consumers need to fulfill within the borders of the European Union. The standards and directives that should be taken into consideration for CE marking the bulbs and the preparation of the declaration of conformity are:

  • Low Voltage Directive (LVD) - 2014/35/EU
  • TS EN 61347 Lamp control system
  • Electromagnetic Compatibility Directive (EMC) - 2014/30/EU
  • Electromagnetic interference (EMI)
  • TS EN 55015 Limit values ​​and measurement methods of radio distortion characteristics of electrical lighting and similar equipment
  • TS EN 61000 Electromagnetic compatibility (EMC)
  • TS EN 62493 Inspection of illumination equipment for people exposed to electromagnetic fields
  • Electromagnetic sensitivity
  • TS EN 61547 General lighting devices - EMC immunity rules
  • TS EN 61000 Electromagnetic compatibility (EMC)
  • 2009/125/EC Energy Related Products Directive (Eco-Design)
  • Hibernate power
  • 2011/65/EU Restriction of Hazardous Substances (RoHS) Directive
  • TS EN IEC 63000 Technical documentation for the evaluation of electrical and electronic products according to the limitation of hazardous substances.

For producing a good product, the production and design must be in line with the aforementioned safety standards. These standards include equipment such as lamp holders called luminaires in the lighting industry and lamps. Products designed and manufactured corresponding to these standards are normally subject to legal regulations of the Low Voltage Directive (LVD), the Electrical Equipment Safety Directive and the General Product Safety Directive.

The European Union Directives have many more requirements in addition to safety that have to be taken into account during the design, production & final disposal of the lighting product. Some of these additional requirements are:

  • Electromagnetic Compatibility Directive (EMC): This directive is applicable on electrical and electronic products and comprehends the immunity to electromagnetic interference and electromagnetic emissions.
  • Energy Related Products Directive (ERP): This applies mostly on lighting products and covers minimum energy efficiency & performance considerations.
  • Resistance of Hazardous Substances Directive (RoHS): Applies to all electrical products and prevents use of certain substances.
    Waste Electrical and Electronic Equipment Directive (WEEE): Applies to all electrical products and covers the disposal and recycling of waste.
  • Registration and Evaluation of Chemicals Directive (REACH): It is applicable on all products and covers the notification and restriction of certain chemicals.
  • Energy labeling (of lamps): It is the application of energy labeling between LV and is applied to residential lamps, though it can be extended to all lamps.

CE mark is only applied on some types of lighting products. The CE marking of the product is done after completion of the required documentation and declaration of conformity. This proves that the products are manufactured in accordance with the requirements stated in the directives mentioned above.

CE Certification of bulbs service is only one of the services provided by Eurotech Assessment and Certification Services Pvt. Ltd. among many others. Many other certification services like CE Certification for medical devices, electrical/electronics, construction, pressure equipment, RoHS etc. are also available. We also provide testing services for your electrical/electronic products through our sister concern.

For more information, contact trg@eurotechworld.net or fill out the form below to get your QUOTE for CE Certification today

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CE Certification for Surgical Mask

CE marking is a certification application that started in European Union (EU) countries. CE marked products can be used and sold without any restrictions within the European Union. Products bearing CE mark have proven to meet all health, safety and environmental requirements. However, now it has become a generally accepted practice all over the world.

All personal protective equipment like dust masks, work shoes, work gloves and other PPE must be certified in accordance with CE criteria. The users of the products bearing this mark, are assured that the product is safe and provides strong protection. The CE mark on the device and equipment used in the medical field contributes a separate safety and reliability. Surgical masks are also included in this. The fundamental use of a surgical mask is to prevent the biological particles that will spread through the mask from the wearer of the respiratory tract into the working environment and to other people or patient.

In order to put CE mark on surgical masks, the main standard that needs to be complied with is the TS EN 149 standard (Respiratory protective devices - Half masks with filters for protection against particles - Properties, experiments and marking standard). This standard states the minimum conditions for half masks with filters, respiratory equipment used for protection against particles that cannot be removed from the environment.

Surgical masks that conform to EN 149 should fit tightly on the face and have a sealing between the mask and the face. If the masks are designed as such, breathable air does not escape through the mask wall and passes through filter. This is the reason for why it is important for surgical masks to pass the conformity test.

Surgical masks of type N95 (FFP3) particle filter fall under the third category within the scope of PPE and are masks that meet the standard requirements. Additionally, they must meet the resistance tests against splashes of blood or other infectious liquids. Surgical masks are mainly used in operating rooms.

Only those surgical masks that pass these tests under the responsibility of the manufacturer can bear the CE mark and get CE Certification.

Eurotech Assessment and Certification Services Pvt. Ltd. provides CE Mark Certification for all classes of Medical Devices. Within the scope of our certification services, we also provide CE Certification for surgical masks. Our Certification Team of experts help you in meeting all the essential requirements of Medical Devices Directive of the European Union. We not only provide Certification but also provide testing services for your medical device through our sister concern.

For more information, contact trg@eurotechworld.net or fill out the form below to get your QUOTE today.

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CE Certification for Medical Mask

ce for medical mask

CE Mark certification is an important product certification for many products to enter into the European market. Lately, with the outbreak of coronavirus pandemic, the CE certification of masks has become very popular.

Putting it simply, surgical masks are masks used by sick people, so as not to spread the virus or the disease. Whereas, the masks used by healthcare workers to protect themselves are medical masks. Those with a high risk of contact should wear respirators (N95) and those with a low risk should use a surgical mask.

Surgical masks need to fulfill the requirements of the Medical Devices Directive (MDD) - 2017/745 of the European Union and should be manufactured in accordance with these principles. Surgical masks fall under Class Ⅰ of the medical equipment classification.

Class Ⅰ of the medical equipment is the category of Personal Protective Equipment (PPE). Equipment under this category does not disturb the user, does not cause any irritation or similar effects during the use, and safeguards against minimum risks. Thus, this personal protective equipment is only suited in situations of minimal risk.

CE certified and approved filters and masks that comply with EN 149 are one of the measures that reduce coronavirus exposure. These medical masks are designed to protect users from exposure to airborne particle hazards. Major particles in the air are biological agents such as viruses and bacteria, and these can be filtered by particle filter medical masks.

Unlike industrial particles, permissible exposure limits for biological pollutants such as viruses that cause epidemics have not been established. Therefore, these masks do not guarantee that users will not get infected. These masks only reduce exposure and are protective.

Medical masks supporting the CE mark must meet the following requirements of the EN 149 standard:

  • Cleaning and disinfection
  • Application related performance
  • Flammability
  • Compatibility with the skin
  • Leakage
  • The carbon dioxide content of the breathing air
  • Mask ties
  • Field of view
  • Exhalation valves
  • Respiratory resistance
  • Occlusion

Eurotech Assessment and Certification Services Pvt. Ltd. provides CE Mark Certification for all classes of Medical Devices. Within the scope of our certification services, we also provide CE Certification for medical masks. Our Certification Team of experts help you in meeting all the essential requirements of Medical Devices Directive of the European Union. We not only provide Certification but also provide testing services for your medical device through our sister concern.

For more information, contact trg@eurotechworld.net or fill out the form below to get your QUOTE today.

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Categorization of Medical Devices

ClassGeneral ControlsRiskDescriptionExample
Class Ⅰ1) Sterile (Is)
2) Measuring (Im)
LowDevices that have least interaction with the bodyHospital beds, sterile plasters, weighing scales, thermometers etc.
Class ⅡaSpecial Controls required. May need special labelling, obligatory performance standards and post-market supervisionMediumDevices which are used to check or diagnose the medical conditions or are involved in the exchange of energy with the patient in a curative manner. Generally invasive, but limited to natural orifices. Included in Class Ⅱb if hazardous to patient.Hearing aid, electrical wheelchairs etc.
Class ⅡbSpecial Controls as Class ⅡaMediumSurgically invasive devices that are totally or partially implantable in the body and may modify the proportion of the body fluidsSurgical lasers, ventilators, infusion pumps etc.
Class ⅢPre-market approval is required to establish safety and effectiveness of these devicesHighSupport and sustain human life and are of utmost importance to prevent deterioration of human health or which present a possible unreasonable risk of injury or illness. Also includes devices that directly come in contact with the Central Circulatory System or comprise a medicinal productNeurological and Vascular implants, silicone-gel filled breast implants, replacement heart valves etc.

Eurotech Assessment and Certification Services Pvt. Ltd. provides CE Mark Certification for all classes of Medical Devices. Our Certification Team of experts help you in meeting all the essential requirements of Medical Devices Directive of the European Union. We not only provide Certification but also provide testing services for your medical device through our sister concern.

For more information, contact trg@eurotechworld.net or fill the form below to get your QUOTE today.

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Top 10 Non – Conformities

At some point, during your business operations, you will experience a failing in one of its important processes. Therefore it’s important to ensure that your business has the following procedures and processes in place to help lessen the affect of such risks:

  • A documented System: Your ability to step back and take a look at your day to day operations will be limited, if you have not documented all the recordable procedures and processes within your organization. This will stop you from solving out unwanted issues and improving efficiency throughout the product’s life-cycle.
  • An error log: Errors may be repeatedly happening but no one may bring those to the attention of management. This may happen due to the reason that no one sees it as their job to do so. Making a log of the non conformities helps you to review and control them, and also restricts the small issues to escalate into unsatisfied customers and lost business.
  • Process for seeking customer feedback: Customers are an essential part of every business and therefore their needs should be important to you. With the changing trends, knowing if those needs are being met will help you to improve your product or service, ensure repeat business, give a competitive advantage and reduce errors.
  • Staff Training Register: Training of staff is important for any business. It will increase the morale of the employees, and will provide you with a skilled workforce. Staff training register will provide evidence of the qualifications and education of the employees when required.
  • A final inspection procedure: What you deliver and how you deliver is important for your business. Carrying inspections of the procedures and processes relating to the delivery of your services/products, at the end of the journey, will help you to spot things that you may wish to do differently, helping you to streamline processes and save costs.
  • Regular process checks: It is a good practice for management to carry out regular checks during the product/service delivery process, which will ensure that everything is running efficiently and will help you to note anything that could be preventing you from achieving the desired goal.
  • Documented procedure for design and development: For those companies which are affected by design and development, it is important to map out how design is undertaken, showing the client the stages involved. This helps to ensure consistent delivery of service.
  • Traceability of design and development records: It is important to ensure that the steps undertaken while mapping out the design are logged along the way. This will provide you with traceable records, should anything be questioned in future.
  • Procedure for calibration: Where exact measurements & calibration are required, a proper procedure should be in place to ensure that they are carried out correctly. You should ensure that these are in accordance with the manufacturer’s guidelines and any legal requirements which may apply. This will help you to avoid unnecessary fines and will protect your reputation.
  • Staff induction records: Poorly trained staff leads to poorly delivered products and services. Therefore, it is important that the staff undergoes a proper induction process. This will ensure that processes are adequately followed and the desired level of service is maintained.

ISO 9001 can provide you with a framework to manage all these non-conformities, which will ultimately free up your valuable management time.

Eurotech ACSPL is an IRCA approved training partner (ATP) and conduct ISO 9001:2015 Quality Management System Trainings and Certifications in Delhi, Mumbai, Chandigarh, Chennai, Lucknow and Ahmedabad. We provide both in-house as well as open-house trainings at reasonable fee. To know more about these trainings, drop an email at trg@eurotechworld.net or call us at +91 9316744482 or 0172 - 4191128.

Changes in ISO 17025:2017

The older version of ISO 17025 was the second edition which was published in 2005. Since then, the market has undergone many changes. To meet these changes and to establish a harmonization among other existing international standards, ISO 17025:2005 was revised and upgraded to ISO 17025:2017. This updated standard is based on a new structure which aligns it with other existing ISO/IEC conformity assessment standards.

The changes in ISO 17025:2017 are:

  • A new topic on risk based thinking has been added which has enabled reduction in standard’s prescriptive guidelines and replaced them with performance based guidelines
  • Increased flexibility in the guidelines for documented information, procedures, organizational responsibilities and processes.
  • Update in the terminology.
  • Recognition and incorporation of computer systems, e-records, and production of electronic reports and results.
  • Addition of all laboratory activities in the scope of the standard which includes calibration, testing and sampling related with subsequent testing and calibration.

Eurotech Assessment and Certification Services Pvt. Ltd. conducts ISO 17025:2017 Upgradation and Internal Auditor Course at reasonable fees. Drop an e-mail at trg@eurotechworld.net  or call at +91-9316744482 to know more about this training.

ISO 17025:2017 and ISO 9001:2015

The difference between ISO 17025:2017 and ISO 9001:2015 is in the applicability of the standards. ISO 9001:2015 can be applied to all types of industries as its requirements are very generic, whereas ISO 17025:2017 is applicable only on calibration laboratories as its requirements are very specific as to what you need to implement in calibration laboratories.

ISO 17025:2017 explains that a Quality Management System is necessary for the proper functioning of a calibration laboratory, and then provides you with two options i.e. Option A and Option B.

If the laboratory has not implemented ISO 9001, then a minimum set of QMS requirements which are needed for the applicability of ISO 17025:2017, need to me fulfilled. This is referred to as Option A. On the other hand, Option B states that if you have a QMS which meets the requirements of ISO 9001:2015, then you have everything that you need.

However, it is important to note that while ISO 9001 implementation is nice to have, it is not required to comply with ISO 17025:2017.

iso 17025 and iso 9001

If you fulfill just the minimum requirements of ISO 17025:2017 instead of requirements of ISO 9001:2015, some of the things that will be missing from your QMS are:

  • Context of The Organization: ISO 17025 does not talk about identifying and specifying your interested parties, internal and external issues or about establishing the scope of our QMS.
  • Quality Objectives: ISO 9001:2015 has important improvement goals for the QMS which are not included in ISO 17025:2017.
  • Leadership: Although some leadership commitment is there, there is no listing of leadership commitments, including the quality policy, in ISO 17025:2017.
  • Monitoring and Measurement: While there are some requirements of monitoring and measurement in ISO 17025:2017, these do not address all of the requirements of ISO 9001:2015.
  • Some Support Processes: Though ISO 17025:2017 includes many support and resource requirements as it applies to calibration laboratories, but it does not include all the requirements from ISO 9001:2015. For example, it does not include requirements about organizational knowledge.

ISO 17025:2017 standard is basically a set of how – to instructions for calibration laboratories to address these requirements. This is the reason that Option B exists in the standard as some companies will find it helpful to implement all of ISO 9001:2015 requirements rather than just the minimum.

Eurotech Assessment and Certification Services Pvt. Ltd. conduct ISO 9001:2015 and ISO 17025:2017 Trainings as well as Certifications (Only of ISO 9001) at reasonable fees. Drop an e-mail at trg@eurotechworld.net or call +91-9316744482 to know more about these trainings.