Category: CE for Medical Devices

CE for Personal Protective Equipment

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Personal protective equipment refers to the equipment that safeguards employees against safety and health risks at work. It is the responsibility of employers to ensure the use and supply of this equipment in the employee’s work environment. Major Personal Protective Equipment (PPE) comprises of materials such as eye protection, safety shoes, safety helmets, safety belts, gloves and high visibility clothing.

Training studies, procedures, implementation instructions and inspections provided to make safe work environments and encourage employees to work responsibly and safely are essential elements for personal protection. Even where safe work systems and engineering controls are implemented, not all hazards can be prevented. The main health risks to employees are:

  • Skin disorders due to contact with abrasive substances
  • Head and foot injuries due to falling materials
  • Lung diseases due to breathing dirty air
  • Various body conditions due to exposure to extreme heat or cold air
  • Eye disorders due to flying particles or splashing of corrosive liquids

It is necessary to use PPE to reduce risks and be protected from all these situations.

The primo thing is to take all kinds of preventive measures in working environments against dangers. Requirement of PPE should be a last resort. It must be provided by employers to their employees free of charge if it is still required after finishing the other checks. Personal protective equipment should be chosen discreetly and trained for the correct use by employees.

Personal protective equipment (PPE) directive 2016/425/EU is published in the European Union. In India, the Regulation on the Use of Personal Protective Equipment in the Workplace has been issued by the Department of Health and Social Care. The purpose is to ensure that risks in work environments are averted or mitigated if the risks cannot be avoided. If risks cannot be prevented inspite the measures taken, personal protective equipment is needed. The Regulation sets out the principles for the supply, use and specification of personal protective equipment.

The European Union directive stipulates that all the products falling within the scope of PPE equipment must be CE marked. When selecting personal protective equipment, it has to be ensured that it is CE marked.

PPE is defined in Directive 2016/425 as follows: “Any device or material designed to be worn or held by employees for protection against one or more health and safety hazards. This means that personal protective equipment can be worn or not worn by the employee to perform the protection function. This equipment may not be designed to connect and secure to a reliable point.”

For CE marking application, personal protective equipment can categorized into:

  • Category I: PPE for the protection of workers against the minimum risks as defined in the Annex of the Directive
  • Category II: PPE not covered by Category I or Category III
  • Category III: PPE for the protection of workers from very serious risks like irreversible damage to the health or death as defined in the Annex of the Directive.

For category I, the manufacturer simply has to prepare the test file and place the CE mark on the product. For Category II, the manufacturer has to prepare the technical dossier, carry out tests and affix the CE mark on the product after issuing a declaration of conformity. For Category III, the product has to be factory tested prior to the declaration of conformity.

Our company also provides personal protective equipment CE Certificate services within the scope of certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.

Personal protective equipment CE Certification services provided within the scope of certification services are only one of the services provided by our organization in this respect. Many other certification services like CE Certification for medical devices, electrical/electronics, pressure equipment, RoHS etc. 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 Surgical Mask

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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

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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

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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.

GET QUOTE