ISO 9001 specifies requirements for a quality management system when an organization:
needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The international symbol for 'food safe' material. The symbol identifies that the material used in the product is safe for food contact.
The regulation is applicable to any product intended for food contact whether it be made of metals, ceramics, paper and board, and plastics.
Special instructions to be observed for safe and appropriate use.
The CE Mark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA.
The CE marking is the manufacturer”s declaration that the products meet the requirements of the applicable EC directives.
Protective gloves against chemicals and micro-organisms. Determination of resistance to penetration.
FDA certification ensures that products meet safety and quality standards set by the U.S. Food and Drug Administration, allowing them to be sold in the United States.
FDA 510(k) is a submission to the FDA for marketing a new medical device by demonstrating its equivalence to an existing approved device.
EN 455 is a European standard that sets requirements for single-use medical gloves, ensuring their quality and safety in healthcare settings.
