BS ISO 16142-1:2016, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This part of ISO 16142 identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).

This part of ISO 16142 also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to medical devices other than IVD medical devices. Future ISO 16142-2 is intended to identify and describe the essential principles of safety and performance, which need to be considered during the design and manufacturing process of IVD medical devices.

NOTE During the design process, the manufacturer selects which of the listed design and manufacturing principles apply to the particular medical device and documents the reasons for excluding others.

This part of ISO 16142 is intended for use as guidance by medical device manufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.


Cross References:
ISO 1135
ISO 3107
ISO 3826
ISO 5356
ISO 5359
ISO 5360
ISO 5361
ISO 5362
ISO 5364
ISO 5366
ISO 5367
ISO 5832
ISO 5834
ISO 5838
ISO 5840
ISO 5841
ISO 6474-1
ISO 7000
ISO 7010
ISO 7153-1
ISO 7197
ISO 7198
ISO 7199
ISO 7206
ISO 7207
ISO 7376
ISO 7396
ISO 7405
ISO 7494
ISO 7864
ISO 7886
ISO 8185
ISO 8536
ISO 8537
ISO 8637
ISO 8638
ISO 8827
ISO 8828
ISO 8835-7
ISO 9168
ISO 9170
ISO 9360
ISO 9583
ISO 9584
ISO 9626
ISO 9713
ISO 10079
ISO 10524
ISO 10555
ISO 10651
ISO 10993
ISO 11040
ISO/IEEE 11073
ISO 11135
ISO 11137
ISO 11138
ISO 11140
ISO 11197
ISO 11318
ISO 11607
ISO 11608
ISO 11663
ISO 11737
ISO/TS 13004
ISO 13402
ISO 13408
ISO 13485
ISO 13779
ISO 13782
ISO 13958
ISO 13959
ISO 14155
ISO 14160
ISO 14161
ISO 14242
ISO 14243
ISO 14408
ISO 14457
ISO 14602
ISO 14607
ISO 14630
ISO 14644
ISO 14698
ISO 14708
ISO 14879
ISO 14937
ISO/TR 14969
ISO 14971
ISO 15001
ISO 15002
ISO 15223-1
ISO 15882
ISO 15883
ISO 15985
ISO 16061
ISO 17510
ISO 17664
ISO 17665-1
ISO 18472
ISO 18777
ISO 18778
ISO 19054
ISO 20857
ISO 21534
ISO 21535
ISO 21536
ISO 21649
ISO 21969
ISO 22442
ISO 22523
ISO 22610
ISO 22612
ISO 22675
ISO 23328
ISO 23500
ISO 23747
ISO 23907
ISO 23908
ISO/TR 24971
ISO 25424
ISO 25539
ISO 26722
ISO 27186
ISO 80369
ISO 81060
ISO/IEC 15026
IEC/ISO 80601-2
IEC 60118-15
IEC 60336
IEC 60417
IEC 60522
IEC 60580
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-9
IEC 60601-1-11
IEC 60601-1-12
IEC 60601-2
IEC 60627
IEC 60731
IEC 60812
IEC 60825
IEC 60878
IEC 60976
IEC 61168
IEC 61217
IEC 61223-2-6
IEC 61223-3
IEC 61303
IEC 61391
IEC 61674
IEC 61676
IEC 61689
IEC 61846
IEC 61847
IEC 61910-1
IEC 62083
IEC 62220
IEC 62266
IEC 62304
IEC 62359
IEC 62366-1
IEC 62471
IEC 62494-1


All current amendments available at time of purchase are included with the purchase of this document.