Medical device software - Validation of software for medical device quality systems1 Scope This document applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485. This document applies to software used in the quality management system, software used in production and service provision, and software used for the monitoring and measurement of

BS 3332 covers technical specifications such as related definitions

The datatype definitions in these libraries can be used by XML validators and other tools to validate content and make comparisons between values

5 of the PMP)

ISO 15509 specifies the test procedures

BS 463-2 covers the inspection criteria

industrial-process measurement and control systems or parts of systems may be exposed during operation

1 Burst generator

and long-term control of the realized

It applies to dielectric tests with direct voltage

such as BS EN ISO 14001:2004

Types and contents of inspection documents

design and ergonomics