ISO/PAS 18761:2013
(Main)Use and handling of medical devices covered by the scope of ISO/TC 84 — Risk assessment on mucocutaneous blood exposure
Use and handling of medical devices covered by the scope of ISO/TC 84 — Risk assessment on mucocutaneous blood exposure
ISO/PAS 18761:2013 covers requirements for risk assessment on mucocutaneous blood and bodily fluid exposure in relation to the handling of medical devices for the administration of medicinal products covered by the scope of ISO/TC 84.
Utilisation et manipulation des dispositifs médicaux couverts par le domaine d'application du ISO/TC 84 — Évaluation du risque concernant l'exposition au sang mucocutané
General Information
Standards Content (Sample)
PUBLICLY ISO/PAS
AVAILABLE 18761
SPECIFICATION
First edition
2013-03-01
Use and handling of medical devices
covered by the scope of ISO/TC 84 —
Risk assessment on mucocutaneous
blood exposure
Utilisation et manipulation des dispositifs médicaux couverts par
le domaine d’application du ISO/TC 84 — Évaluation du risque
concernant l’exposition au sang mucocutané
Reference number
ISO/PAS 18761:2013(E)
©
ISO 2013
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ISO/PAS 18761:2013(E)
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ii © ISO 2013 – All rights reserved
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ISO/PAS 18761:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 General requirements . 1
4 Information and educational materials provided by suppliers . 1
© ISO 2013 – All rights reserved iii
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ISO/PAS 18761:2013(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
— an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical
experts in an ISO working group and is accepted for publication if it is approved by more than 50 %
of the members of the parent committee casting a vote;
— an ISO Technical Specification (ISO/TS) represents an agreement between the members of a
technical committee a
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