Roland chung
Trusted Information Resource
Hi everyone,
Can you give me some examples of inherent safety by design? Thx.
Can you give me some examples of inherent safety by design? Thx.
If I am reading you correctly, protective measures mean reaction.
Does any ISO document try to explain the inherent design and protective measures?
3.5
inherently safe design
measures taken to eliminate hazards (3.2) and/or to reduce risks (3.9) by changing the design or
operating characteristics of the product or system
risk reduction measure
protective measure
action or means to eliminate hazards (3.2) or reduce risks (3.9)
EXAMPLE Inherently safe design (3.5); protective devices; personal protective equipment; information for
use and installation; organization of work; training; application of equipment; supervision.
In IEC, the protective system is defined to protect the patient against safety hazards which may arise.
Could you please share a typical RM literature?
ISO 14971 6.2 b) protective measures in the medical device itself