Medical devices. Quality management systems. Requirements for regulatory purposesISO 13485: 2016 is the internationally recognized quality management system standard for the medical device industry, with more than 27,000 accreditations worldwide. What is ISO 13485: 2016? ISO 13485: 2016 specifies the requirements for a quality management system for organizations involved in one or more stages of the life cycle of a medical device. It provides the basis for ensuring the consistent design, development, production, installation, and

Electromagnetic compatibility (EMC) requirements – immunity

IEC 60079-10

aspects of healthcare

It states the requirements for energy audits and corresponding obligations within the energy auditing process

Design coefficient

BS EN 10277-2:2008 contains:

Minimum content of the test report

and resource use and efficiency

Slit wide strip of width less than 600 mm

PD 25222 Business continuity management – Guidance on supply chain continuity covers the supply of products and services

The method is described in BS 6349-4

The new standard harmonizes with the latest European recommendations