External limb prostheses and external orthoses – Requirements and test methods (ISO 22523:2006)
Abstract
ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:
- 06 03 – 06 15 Orthoses
- 06 18 – 06 27 Limb prostheses
It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.
This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.
DIN EN ISO 22523:2007-04 (E)
External limb prostheses and external orthoses – Requirements and test methods
(ISO 22523:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….5
Introduction ……………………………………………………………………………………………………………………………………6
1 Scope ……………………………………………………………………………………………………………………………..7
2 Normative references ……………………………………………………………………………………………………..7
3 Terms and definitions ……………………………………………………………………………………………………..8
4 General requirements ……………………………………………………………………………………………………10
4.1 Risk management ………………………………………………………………………………………………………….10
4.2 Intended performance and technical documentation ……………………………………………………..11
4.3 Clinical evaluation …………………………………………………………………………………………………………11
4.4 Strength and related conditions of use ………………………………………………………………………….11
5 Requirements for materials ……………………………………………………………………………………………12
5.1 Flammability of materials and toxicity of combustion products ……………………………………..12
5.2 Biocompatibility, contaminants and residues ………………………………………………………………..13
5.2.1 General …………………………………………………………………………………………………………………………13
5.2.2 Contaminants and residues …………………………………………………………………………………………..13
5.3 Infection and microbiological contamination …………………………………………………………………13
5.4 Resistance to corrosion and degradation ………………………………………………………………………13
6 Noise and vibration ……………………………………………………………………………………………………….13
7 Electromagnetic compatibility (EMC) ……………………………………………………………………………..14
8 Electrical safety …………………………………………………………………………………………………………….14
8.1 Battery-powered prosthetic and orthotic devices …………………………………………………………..14
8.1.1 Battery housings and connections ………………………………………………………………………………..14
8.1.2 Charge level indicators ………………………………………………………………………………………………….14
8.2 Circuit protection ………………………………………………………………………………………………………….15
8.3 Electronic programmable systems ………………………………………………………………………………..15
8.4 Electrically heated blankets, pads and similar flexible heating appliances ……………………..15
8.5 Prosthetic and orthotic devices with skin contact electrodes …………………………………………15
8.6 Prosthetic and orthotic devices with radio equipment ……………………………………………………15
8.6.1 General …………………………………………………………………………………………………………………………15
8.6.2 Frequency spectrum of radio equipment ……………………………………………………………………….15
8.6.3 Operation of radio equipment by the user ……………………………………………………………………..15
9 Surface temperature ……………………………………………………………………………………………………..16
10 Sterility …………………………………………………………………………………………………………………………16
11 Design requirements ……………………………………………………………………………………………………..16
11.1 Safety of moving parts ………………………………………………………………………………………………….16
11.2 Safety of connections ……………………………………………………………………………………………………16
12 Mechanical requirements ………………………………………………………………………………………………16
12.1 Restrictions on use ……………………………………………………………………………………………………….16
12.2 Forces in soft tissues of the human body …………………………………………………………………….. 17
12.3 Ergonomic principles …………………………………………………………………………………………………… 17
13 Information supplied by the manufacturer ……………………………………………………………………. 17
13.1 General ……………………………………………………………………………………………………………………….. 17
13.2 Labelling ……………………………………………………………………………………………………………………… 18
13.3 Intended use ………………………………………………………………………………………………………………… 18
14 Packaging ……………………………………………………………………………………………………………………. 18
Annex A (informative) Guidance on methods of determining the strength of upper-limb prosthetic
devices ………………………………………………………………………………………………………………………… 19
Annex B (normative) Method of determining the mechanical properties of knee joint assemblies for
lower-limb orthotic devices ………………………………………………………………………………………….. 34
Annex C (informative) Guidance on methods of determining the flammability and toxicity of
combustion products of lower-limb prosthetic devices ………………………………………………… 47
Annex D (informative) Guidance on methods of establishing the force or moment required to
operate the control and actuating mechanisms on prosthetic and orthotic devices ………. 61
Annex E (informative) Reference to the essential principles of safety and performance of medical
devices in accordance with ISO/TR 16142 …………………………………………………………………….. 86
Bibliography ……………………………………………………………………………………………………………………………….. 88
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives …………………………………………………………………………………. 89
Figure A.1 — Test sample segment lengths ………………………………………………………………………………….. 21
Figure A.2 — Configuration of test 1 …………………………………………………………………………………………….. 22
Figure A.3 — Configuration of test 2 and test 4 …………………………………………………………………………….. 23
Figure A.4 — Configuration of test 3 and test 5 …………………………………………………………………………….. 23
Figure A.5 — Examples of test sample configurations …………………………………………………………………… 24
Figure B.1 — Example of a test rig design suitable for the application of the four-point loading
system ………………………………………………………………………………………………………………………… 40
Figure B.2 — Arrangements of the four-point loading system (continued on Figure B.3) ……………….. 41
Figure B.3 — Arrangements of the four-point loading system (continued from Figure B.2) …………….. 42
Figure B.4 — Test orientations for joint assemblies intended to restrain motion in four directions
mutually at right angles (see B.5.1) ………………………………………………………………………………. 43
Figure B.5 — Example of a bending moment/angular deflection curve: single-stage failure (see 3.17,
3.18 and 3.19) ………………………………………………………………………………………………………………. 44
Figure B.6 — Examples of a bending moment/angular deflection curve: two-stage failures (see 3.17,
3.18 and 3.19) ………………………………………………………………………………………………………………. 45
Figure C.1 — Test sample dimensions trans-femoral (above-knee) — Finished limb ……………………….. 54
Figure C.2 — Test sample dimensions trans-tibial (below-knee) — Finished limb …………………………… 55
Figure C.3 — Test sample dimensions trans-femoral (above-knee) — Socket former ………………………. 56
Figure C.4 — Test sample dimensions trans-tibial (below-knee) — Socket former ……………………………56
Figure C.5 — Radiant heat source test ……………………………………………………………………………………………57
Figure C.6 — Flaming ignition source test ……………………………………………………………………………………..58
Figure C.7 — Sample support frame and weighing platform ……………………………………………………………59
Figure D.1 — Bowden cable arrangement during test ……………………………………………………………………..75
Figure D.2 — Test set-up according to D.6.2 for sample category D.3.1 a) Orthotic knee joints with
locking mechanism ……………………………………………………………………………………………………….76
Figure D.3 — Test set-up according to D.6.3 for sample category D.3.1 b) Orthotic elbow joints with
locking mechanism ……………………………………………………………………………………………………….76
Figure D.4 — Test set-up according to D.6.4 for sample category D.3.1 c) Prosthetic knee units with
locking mechanism (continued on Figure D.5) ……………………………………………………………….77
Figure D.5 — Test set-up according to D.6.4 for sample category D.3.1 c) Prosthetic knee units with
locking mechanism (continued from Figure D.4) ……………………………………………………………78
Figure D.6 — Test set-up according to D.6.5 for sample category D.3.1 d) Prosthetic elbow units
with locking mechanism ………………………………………………………………………………………………..78
Figure D.7 — Test set-up according to D.6.6 for sample category D.3.1 e) Prosthetic elbow units
with user-driven articulation ………………………………………………………………………………………….79
Figure D.8 — Test set-up according to D.6.7 for sample category D.3.1 f) Terminal devices with
built-in closing function ………………………………………………………………………………………………..80
Figure D.9 — Test set-up according to D.6.8 for sample category D.3.1 g) Terminal devices with
built-in opening function ……………………………………………………………………………………………….81
Figure D.10 — Test set-up according to D.6.9 for sample category D.3.1 h) Terminal devices with no
built-in closing or opening function, actuated by force application …………………………………82
Figure D.11 — Test set-up according to D.6.10 for sample category D.3.1 i) Terminal devices with
no built-in closing or opening function, actuated by torque application ………………………….83
Figure D.12 — Test set-up according to D.6.11 for sample category D.3.1 j) Terminal devices with
break-open feature for emergency situations …………………………………………………………………84
Figure D.13 — Test set-up according to D.6.12 for sample category D.3.1 k) Prosthetic devices with
fail-safe release unit, illustrated for a separable prosthetic adaptor plate ……………………….85
Table A.1 — Number of tests and test samples required …………………………………………………………………25
Table B.1 — Example of test report ………………………………………………………………………………………………..46
Table C.1 — Worked example of calculating the TTPD ……………………………………………………………………60
Table D.1 — Parameters of the test set-up for sample category D.3.1 a) ………………………………………….66
Table D.2 — Parameters of the test set-up for sample category D.3.1 c) ………………………………………….68
Table D.3 — Details of the test report ……………………………………………………………………………………………..73
Table D.4 — Values of actuating/operating force (and displacement) and moment measured on
different categories of test sample …………………………………………………………………………………74
Table E.1 — Correspondence between this International Standard and the essential principles of
ISO/TR 16142 ……………………………………………………………………………………………………………….. 87