ISO/DIS 8827

Implants for surgery -- Staples with parallel legs for orthopaedic use -- General requirements

Implants chirurgicaux -- Agrafes à pattes parallèles à usage orthopédique -- Spécifications générales

Standards Content (sample)

DRAFT INTERNATIONAL STANDARD
ISO/DIS 8827
ISO/TC 150/SC 5 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-07-27 2018-10-19
Implants for surgery — Staples with parallel legs for
orthopaedic use — General requirements

Implants chirurgicaux — Agrafes à pattes parallèles à usage orthopédique — Spécifications générales

ICS: 11.040.40
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ISO/DIS 8827:2018(E)
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ISO/DIS 8827:2018(E)
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ISO/DIS 8827:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Design .............................................................................................................................................................................................................................. 1

4.1 Radius of curvature ............................................................................................................................................................................. 1

4.2 Points ............................................................................................................................................................................................................... 2

4.3 Legs ................................................................................................................................................................................................................... 2

5 Size designation ..................................................................................................................................................................................................... 3

6 Tolerances ................................................................................................................................................................................................................... 4

7 Materials ....................................................................................................................................................................................................................... 4

7.1 General ........................................................................................................................................................................................................... 4

7.2 Austenitic stainless steel wire ................................................................................................................................................... 4

7.2.1 Composition ......................................................................................................................................................................... 4

7.2.2 Tensile properties ........................................................................................................................................................... 4

7.3 Cast cobalt-chromium-molybdenum alloy ..................................................................................................................... 5

7.3.1 Composition ......................................................................................................................................................................... 5

7.3.2 Tensile properties ........................................................................................................................................................... 5

7.4 Wrought cobalt-chromium-tungsten-nickel alloy .................................................................................................... 5

7.4.1 Composition ......................................................................................................................................................................... 5

7.4.2 Tensile properties ........................................................................................................................................................... 5

7.5 Wrought titanium alloy .................................................................................................................................................................... 5

7.5.1 Composition ......................................................................................................................................................................... 5

7.5.2 Tensile properties ........................................................................................................................................................... 6

8 Performance evaluation ............................................................................................................................................................................... 6

8.1 General ........................................................................................................................................................................................................... 6

8.2 Bending resistance .............................................................................................................................................................................. 6

8.3 Bending fatigue resistance ............................................................................................................................................................ 6

8.4 Resistance to pull out ........................................................................................................................................................................ 6

9 Finish ................................................................................................................................................................................................................................ 6

10 Packaging ..................................................................................................................................................................................................................... 6

11 Information Supplied by the Manufacturer ............................................................................................................................. 6

Annex A (informative) Guidance on use and selection of staples ........................................................................................... 8

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2018 – All rights reserved iii
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ISO/DIS 8827:2018(E)
Foreword

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The committee responsible for this document is Technical Committee 150, Implants for surgery,

Subcommittee SC 5, Osteosynthesis and spinal devices.

This second edition cancels and replaces the first edition (ISO 8827:1988), which has been technically

revised.
The main changes compared to the previous edition are as follows:

— The addition of a new Clause 8 on performance evaluation for determining the suitability of

bone staples
iv © ISO 2018
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