STN EN ISO 14971
| Name: | STN EN ISO 14971 |
| Validity: | Withdrawn |
| Number of pages: | 50 |
| Language: |
EN
|
| Paper: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| Slovak title | Zdravotnícke pomôcky. Aplikácia manažérstva rizika pri zdravotníckych pomôckach (ISO 14971: 2019) |
| English title | Medical devices - Application of risk management to medical devices (ISO 14971:2019) |
| Release Date: | 01. 04. 2020 |
| Date of withdrawal: | 01. 04. 2021 |
| ICS: | 11.040.01 |
| Sorting character/National clasification code | 85 5231 |
| Level of incorporation: | idt EN ISO 14971:2019, idt ISO 14971:2019 |
| Official Journal | 03/20 |
| Amendments | |
| Replaced by: | STN EN ISO 14971:2021-04 (85 5231) |
| Repleces: | STN EN ISO 14971:2013-02 (85 5231) |
| Note in Official Journal: | Norma rozpracovaná prekladom. |
| Subject of the standard: | This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. |
| Preview: | Náhľad normy (PDF) |