Standard Svensk standard · SS-ISO 15223-2:2017

Medicintekniska produkter - Symboler att användas vid märkning av produkt och information till användare - Del 2: framtagning, urval och validering (ISO 15223-2, IDT)

Status: Gällande

Omfattning
This part of ISO 15223 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.
The purpose of this part of ISO 15223 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

If the symbol validation process detailed in this part of ISO 15223 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

This part of ISO 15223 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

Ämnesområden

Speciell utrustning (01.080.20) Medicinsk utrustning allmänt (11.040.01)


Produktinformation

Språk: Engelska

Framtagen av: Kvalitetsledning- och riskhanteringssystem samt andra tillhörande standarder för medicinteknik, SIS/TK 355

Internationell titel: Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation (ISO 15223-2, IDT)

Artikelnummer: STD-8026011

Utgåva: 1

Fastställd: 2017-04-18

Antal sidor: 32