Cart
0
Product
Products
(empty)
No products
To be determined
Shipping
$0.00
Total
Product successfully added to your shopping cart
Quantity
Total
There are 0 items in your cart.
There is 1 item in your cart.
Total products
Total shipping
To be determined
Total
Reduced price!
View larger
View larger
JIS T 14971:2012 (R2016)
New product
JIS T 14971:2012 (R2016)
Medical devices - Application of risk management to medical devicesMore info
This Japanese Industrial Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic medical devices to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this Standard are applicable to all stages of the life-cycle of a medical device.
| Author | JSA |
|---|---|
| Editor | JSA |
| Document type | Standard |
| Format | File |
| Confirmation date | 2016-10-25 |
| ICS | 11.040.01 : Medical equipment in general
|
| Number of pages | 80 |
| Replace | JIS T 14971 (2003-08-25) |
| Cross references | ISO 14971 (2007-03), IDT |
| Year | 2012 |
| Document history | JIS T 14971 (2012-03-01) |
| Country | Japan |
| Keyword | JIS 14971;14971 |