Cnc Services

Cnc Services CNC SERVICES was established in 2008 with aims to provide highest quality of service with updated information.

✅ KN95 Face Mask With Filter Bulk Quantity Available Interested person contact me03406881029
20/06/2020

✅ KN95 Face Mask With Filter Bulk Quantity Available Interested person contact me
03406881029

✅ Construction Products Regulation(CPR) 305/2011The Construction Products Regulation No 305/2011, is intended to make pr...
11/06/2020

✅ Construction Products Regulation(CPR) 305/2011
The Construction Products Regulation No 305/2011, is intended to make products arriving in any European Union country safe to use and install. The directive harmonizes all construction products subject to regulatory controls for CE marking purposes.

✅ The main goal of the Construction Products Regulation is to improve the framework conditions for the competitiveness of the construction and construction products industries. The regulation requires that construction products are suitable for use in construction works. Therefore, the essential requirements regarding safety, public health, protection of citizens, and the environment must be fulfilled.

✅ Construction Products Regulation (CPR)

✅ The Construction Products Regulation (CPR) lays down harmonized rules for the marketing of construction products in the EU. The Regulation provides a common technical language to assess the performance of construction products. It ensures that reliable information is available to professionals, public authorities, and consumers, so they can compare the performance of products from different manufacturers in different countries.

✅ Benefits of CPR for stakeholders

✅ free circulation of construction products in the EU’s Single Market– products have to be tested only once according to a harmonised European standard or European Assessment Document
national authorities can set performance requirements using the harmonised European standard or European Assessment Document
users of construction products can better define their performance demands
market surveillance can rely on one common information structure.

✅ MEDICAL DEVICE DIRECTIVE(MDD) 93/42/EECMDD 93/42/EEC (Medical Device Directive) has been in place since June 14, 1998....
08/06/2020

✅ MEDICAL DEVICE DIRECTIVE
(MDD) 93/42/EEC
MDD 93/42/EEC (Medical Device Directive) has been in place since June 14, 1998. It was amended on September 5, 2007. The consolidated directive will become mandatory on March 21, 2010. The directive establishes essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices. A medical device is defined as any instrument, apparatus, appliance, software, material or other article.

✅ The MDD 93/42/EEC has recently been amended. The 2007/47/EC amendment was established on September 5, 2007 and the consolidated directive will be mandatory on March 21, 2010. The amendment is necessary due to continual advancements in technology and development of international initiatives. The Commission is to constantly analyze the directives in order to ensure the protection of the patients. The amendment has such changes as the definition of a medical device, things which are not considered a medical device, explanation of Member State’s role, etc.

✅ Classes The Medical Device Directive establishes in Annex IX the different classifications for devices.Class I– Devices low risk devices. The devices are non-evasive, non active, non sterile, non powered, non measuring and do not pe*****te into the body. The manufacturer must complete a technical file.
Class IIa– Devices low-medium risk devices such as a hearing-aid. Devices that are within the body between 60 minutes and 30 days fall within this class. This class also warrants technical files as well as having a European Notified Body perform a conformity test.
Class IIb– Devices are medium-high risk. The devices in this class are in the body more than 30 days. Examples include ventilators and intensive care monitoring equipment. Compliance route is the same as Class IIa with an additional step of type examination of the device by the European Notified Body.

✅ Class III– These are high-risk devices. Some examples are balloon catheters and prosthetic heart valves. The steps to approval are audit of the full quality assurance system and examination of the design by the European Notified Body examination and testing of the device.

✅ We provide Assistance!We assist product complies with EU safety, health and environmental requirements, and how to pla...
03/06/2020

✅ We provide Assistance!
We assist product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product. We also provide assistance of FDA regulation and ISO certification.
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03/06/2020
✅ The Low Voltage Directive (LVD) 2014/35/EUThe Low Voltage Directive (LVD) (2014/35/EU) ensures that electrical equipme...
02/06/2020

✅ The Low Voltage Directive (LVD) 2014/35/EU
The Low Voltage Directive (LVD) (2014/35/EU) ensures that electrical equipment within certain voltage limits provides a high level of protection for European citizens, and benefits fully from the Single Market. It has been applicable since 20 April 2016.

✅ About the Low Voltage Directive (LVD)

✅ The LVD covers health and safety risks on electrical equipment operating with an input or output voltage of between:

✅ 50 and 1000 V for alternating current
75 and 1500 V for direct current
Equipment covered under the Low Voltage Directive includes:

✅ Electrical appliances
✅ Lighting equipment
✅ Electrical cables
✅ Power Supply Units
✅ Laser equipment
✅ Components, for example, fuses
Where an electrical product satisfies the requirements of the LVD, along with the conditions of any other relevant directive, the manufacturer can affix the CE Mark, allowing them to freely circulate their products throughout the European market.

✅ The Directive excludes:

✅ Electrical equipment for use in an explosive atmosphere
Electrical equipment for radiology and medical use
Electrical parts for passenger lifts
Plugs and sockets for domestic use

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