Standard Tekniska rapporter · SIS-ISO/TR 24971:2014

Medicintekniska produkter - Vägledning vid tillämpningen av ISO 14971 (ISO/TR 24971:2013, IDT)

Status: Gällande

Omfattning
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management.

The guidance is intended to assist manufacturers and other users of the standard to:
— understand the role of international product safety and process standards in risk management;
— develop the policy for determining the criteria for risk acceptability;
— incorporate production and post-production feedback loop into risk management;
— differentiate between “information for safety” and “disclosure of residual risk”; and
— evaluate overall residual risk.

Ämnesområden

Medicinsk utrustning allmänt (11.040.01) Medicintekniska kvalitetssystem (11.110.10)


Produktinformation

Språk: Engelska

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

Internationell titel: Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2013, IDT)

Artikelnummer: STD-103217

Utgåva: 1

Fastställd: 2014-10-17

Antal sidor: 28