UL/ISI/GE/GMP Marking


UL Marking

The UL Listing Mark is one of the most common UL Marks. If a product carries this Mark, it means UL found that representative product samples met UL's safety requirements. These requirements are primarily based on UL's own published standards for safety. This type of Mark is seen commonly on appliances and computer equipment, furnaces and heaters, fuses, electrical panel boards, smoke and carbon monoxide alarms, fire extinguishers and sprinkler systems, personal flotation devices, bullet resistant glass, and thousands of other products.

There are three variations of UL's Listing Mark: one used only in the United States, one used only in Canada and one for both the United States and Canada. The C-UL Mark is applied to products for the Canadian market. The products with this type of Mark have been evaluated to Canadian safety requirements, which may be somewhat different from U.S. safety requirements. The optional C-UL-US Mark indicates compliance with both Canadian and U.S. requirements. UL encourages those manufacturers with products certified for both countries to use this combined Mark, but they may continue using separate UL Marks for the United States and Canada.

The UL Listing Mark appears on end products and complete components suitable for factory and field installation. All of the products carrying a UL Listing Mark are covered by UL's Follow-Up Services program to verify that end products and components carrying the UL Listing Mark continue to be manufactured in compliance with UL's safety requirements.

ISI marking

The BIS product certification scheme is essentially voluntary in nature, and is largely based on ISO Guide 28, which provides general rules for third party certification system of determining conformity with product standards through initial testing and assessment of a factory quality management system and its acceptance followed by surveillance that takes into account the factory Quality management system and the testing of samples from the factory and the open market. All BIS certifications are carried out in accordance with Indian Standards, which are amenable to certification. A large number of operational elements of the BIS product certification scheme correspond with the requirements of ISO Guide 65. BIS has mandatory and voluntary products to be applied for ISI marking. The BIS Product Certification Scheme is open to manufacturers in all countries without discrimination. While a licence can be granted for any Indian Standard specifying product characteristics, which is amenable to certification, the broad areas of technologies now under certification are:

• Textiles
• Chemicals and Pesticides
• Rubber and Plastic products
• Cement and concrete products
• Building materials
• Pumping, irrigation, drainage and sewage equipment
• Pipes and fittings for water supply
• Basic metals and fabricated metal products

GE marking

GE Healthcare has announced CE marking for SenoClaire, GE’s new generation of breast tomosynthesis solution designed with a three-dimensional imaging technology. SenoClaire technology uses a low-dose short X-ray sweep around the positioned breast with nine exposures acquired with a “step-and-shoot” method, removing the potential motion from images.

“We are thrilled to receive the CE marking for this important product in our Women’s Health business. We continue to innovate our portfolio and aim to help clinicians expand care to more women globally in order to help reduce breast cancer. Our goal was to pioneer an upgrade solution for both our digital mammography platforms, Senographe* Essential and Senographe Care, providing flexibility for customers to enhance their clinical offering for their clinic and patient workflow,” said Prahlad Singh, General Manager, Women’s Health, GE Healthcare - Detection & Guidance Solutions (DGS).

GMP marking

W.H.O. defines Good Manufacturing Practices (GMP) as "that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization". GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures taken; full traceability of a product through batch processing records and distribution records; and systems for recall and investigation of complaints.

The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. There are many ways this is controlled - controlling the quality of the facility and its systems, controlling the quality of the starting materials, controlling the quality of production at all stages, controlling the quality of the testing of the product, controlling the identity of materials by adequate labeling and segregation, controlling the quality of materials and product by adequate storage, etc. All of these controls must follow prescribed, formal, approved procedures, written as protocols, SOPs, or Master Formulae, describing all the tasks carried out in an entire manufacturing and control process.



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