Specifies a procedure to investigate, using available information, the safety of medical devices by identifying hazards and estimating the risks associated with the device (risk analysis). This Standrad applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendererd non-viable.
More Standards PDF
AS ISO 54321:2023
$50.00 $100.00
AS ISO 12647.3:2023
$40.00 $80.00
AS 60896.22:2023
$35.00 $71.00
AS ISO 12647.1:2023
$40.00 $80.00