Source: https://infostore.saiglobal.com/en-au/standards/iso-tr-24971-2013-601666_saig_iso_iso_1377710/
Timestamp: 2020-05-25 23:59:05
Document Index: 256784796

Matched Legal Cases: ['ART 2', 'ART 2', 'ART 2', 'ART 2', 'ART 2', 'ART 2']

ISO TR 24971 : 2013 | MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 14971 | SAI Global
ISO TR 24971 : 2013
MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 14971
2 The role of international product safety and process
standards in risk management
3 Developing the policy for determining the criteria
for risk acceptability
4 Production and post-production feedback loop
5 Differentiation of information for safety and
disclosure of residual risk
6 Evaluation of overall residual risk
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management.
Committee TC 210
NBR ISO/TR 24971 : 2014 Identical
DS ISO/TR 24971 : 2013 Identical
SIS-ISO/TR 24971:2014 Identical
AAMI ISO TIR 24971 : 2013 Identical
BS PD ISO/TR 24971 : 2013 Identical
NEN NPR ISO/TR 24971 : 2013 Identical
AAMI ISO TIR 24971 : 2013 : R2016 Identical
BS ISO 16142-2 : 2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
BS PD IEC TR 62366-2 : 2016 MEDICAL DEVICES - PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
BS PD ISO/TS 17518 : 2015 MEDICAL LABORATORIES - REAGENTS FOR STAINING BIOLOGICAL MATERIAL - GUIDANCE FOR USERS
16/30346073 DC : 0 BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
AAMI ISO 16142-2 : 2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
ANSI C63.27 : 2017 EVALUATION OF WIRELESS COEXISTENCE
ISO TS 17518 : 2015(R2018) MEDICAL LABORATORIES - REAGENTS FOR STAINING BIOLOGICAL MATERIAL - GUIDANCE FOR USERS
ISO 16142-2 : 2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
IEC TR 62366-2 : 1ED 2016 MEDICAL DEVICES - PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
PDF - English PDF - Russian