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Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Description
Guide to the development and inclusion of aspects of safety in International Standards for medical devices1 Scope This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well established risk management concepts and methodology. This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these. In this document, the term product includes a medical device or a system
Manufacturers / distributors / suppliers of thermoplastic covering films
optical fibres
— the first procedure is applicable for aggregates tested in dry condition
This is not just in terms of cooling
BS 5489‑1 provides an illuminated environment for the quick movement of vehicles and assist traffic safety for all urban residents including pedestrians
Guided type fall arresters including a rigid anchor line conforming to BS EN 353-1+A1 are components of one of the fall arrest systems covered by EN 363
BS 2819 on methods for the determination of bow
The tests described are also applicable to products that have received a preservative treatment
A gas cylinder is a pressure vessel for the storage and containment of gases at above atmospheric pressure
1 This document applies to high expansion foam generators
and gases at a pressure significantly higher or lower than the ambient pressure
BS EN 358 specifies the requirements
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