ISO/IEC GUIDE 63:2012 Withdrawn
Guide to the development and inclusion of safety aspects in International Standards for medical devices
Abstract
ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.
ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
Additional information
Publication type | Guide |
---|---|
Publication date | 2012-01-10 |
Withdrawal date | 2019-08-12 |
Edition | 2.0 |
Available language(s) | English, Russian |
TC/SC | ISO/TC 210 - Quality management and corresponding general aspects for medical devicesrss |
ICS | 01.120 - Standardization. General rules
11.020 - Medical sciences and health care facilities in general |
Stability date | 2019 |
Pages | 21 |
File size | 580 KB |
The following test report forms are related:
Share your publications
Learn how to share your publications with your colleagues, using networking options.
Payment information
Our prices are in Swiss francs (CHF). We accept all major credit cards (American Express, Mastercard and Visa, JCB and CUP), PayPal and bank transfers as form of payment.
Keep in touch
Keep up to date with new publication releases and announcements with our free IEC Just Published email newsletter.
Contact customer services
Please send your enquiry by email or call us on +41 22 919 02 11 between 09:00 – 16:00 CET Monday to Friday.