Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process1 Scope This document is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993 1. It does not add to, or otherwise change, the requirements of ISO 10993 1. This document does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance is applicable to all biological evaluation of all types of medical devices including active,

Payload handlers

and manure

and the appropriate enterprise authority work together in ensuring that all impacts of Pb-free technology insertion are understood and risks mitigated accordingly

6 Component weight

BS EN 140402-801:2015 includes some technical changes with respect to BS EN 140402-801:2005

including library materials

BS EN 14511-3 is primarily intended for water and brine chilling packages but can be used for other liquid subject to agreement

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BS EN 3717 best practice guidance helps manufacture high-quality tubes that are flame resistant

• Reagents

NOTE1 This does not preclude special arrangements for the products to be used at higher temperatures

BS EN 16210 on transportation load measurements data acquisition is useful for: