EN 1639:2009 Dentistry – Medical devices for dentistry
What is EN 1639:2009 Dentistry – Medical devices for dentistry – Instruments? EN 1639:2009 Dentistry – Medical devices for dentistry is a European standard that specifies the requirements and test methods for instruments used in dentistry, including but not limited to, hand-held cutting, drilling, and condensation instruments. This standard is designed to ensure the safety, […]
ISO Certifications
Global Issues in 2023 and How ISO Certifications Can Help -Introduction The year 2023 has been marked by a multitude of global challenges that range from environmental degradation to cybersecurity threats, labor safety concerns, and quality management issues in various industries. These challenges not only affect individual organizations but also have far-reaching implications for societies […]
HACCP-Hazard Analysis and Critical Control Point
What is HACCP-Hazard Analysis and Critical Control Point? HACCP-Hazard Analysis and Critical Control Point is a systematic approach to food safety management. It is a preventative system that helps identify, evaluate, and control potential hazards in food production processes to ensure the safety of the final product. HACCP is widely used in the food industry […]
IEC 62304:2006-Medical device software
What is IEC 62304:2006-Medical device software — Software life cycle processes IEC 62304:2006-Medical device software, published by the International Electrotechnical Commission (IEC) that outlines the software life cycle processes for medical device software, it provides guidelines and requirements for the development and maintenance of software used in medical devices, ensuring that these software components are […]
ISO 23640:2011-In vitro diagnostic medical devices
What is ISO 23640:2011-In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents? ISO 23640:2011 provides guidelines for the evaluation of stability of in vitro diagnostic (IVD) reagents. In vitro diagnostic reagents are substances or preparations used in diagnostic examinations performed outside the living body, typically in a laboratory setting. The […]
ISO 15223-1:2021-Medical devices
What is ISO 15223-1:2021-Medical devices -Symbols to be used with information to be supplied by the manufacturer? ISO 15223-1:2021 provides guidelines and requirements for the use of symbols in medical device labelling and accompanying information provided by the manufacturer. Here are the key aspects covered by ISO 15223-1:2021: Scope and Purpose: The standard defines the […]
EN 13034 – Protection against liquid chemicals
What is EN 13034 – Protection against liquid chemicals? EN 13034 – Protection against liquid chemicals is a European standard that specifies requirements and test methods for protective clothing designed to provide protection against liquid chemicals. This standard is part of a series of European standards related to personal protective equipment (PPE) and is specifically […]
EN 343:2019 – Protective clothing
What is EN 343:2019 – Protective clothing? EN 343:2019 is a European standard that specifies requirements and test methods for protective clothing against foul weather. It is part of a series of standards that cover various aspects of protective clothing in different environments. EN 343:2019 specifically focuses on protective clothing designed to protect wearers from […]
ISO 14971:2019
What is ISO 14971:2019-Medical devices — Application of risk management to medical devices? ISO 14971:2019 provides guidance and requirements for the application of risk management principles to medical devices throughout their entire lifecycle. The standard outlines a systematic approach to identifying, evaluating, and controlling risks associated with medical devices. It emphasizes the need for manufacturers […]
ISO 10993-Biological evaluation of medical devices
ISO 10993 Part-1 to 23-Biological evaluation of medical devices ISO 10993-Biological evaluation of medical devices is a series of international standards that outline the biological evaluation of medical devices. These standards are published by the ISO and are used to assess the potential risks associated with the use of medical devices on living organisms. The […]
