ISO/TR 17327-2:2021
(Main)Non-active surgical implants — Implant coating — Part 2: Reference standards related to coatings
Non-active surgical implants — Implant coating — Part 2: Reference standards related to coatings
This document provides lists of reference standards which contain general information, implant device or application-specific information, material specifications, or test methods related to coatings. These reference standards can be used to develop product coatings for specified applications when using ISO 17327-1 to address general coating requirements. This document is applicable to coatings on non-active surgical implants.
Implants chirurgicaux non actifs — Revêtement de l'implant — Partie 2: Normes de référence relatives aux revêtements
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TECHNICAL ISO/TR
REPORT 17327-2
First edition
2021-04
Non-active surgical implants —
Implant coating —
Part 2:
Reference standards related to
coatings
Reference number
ISO/TR 17327-2:2021(E)
©
ISO 2021
---------------------- Page: 1 ----------------------
ISO/TR 17327-2:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TR 17327-2:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Reference standards for coatings . 1
4.1 General standards . 1
4.2 Implant-related standards . 2
4.2.1 Cardiovascular implant standards . . 2
4.2.2 Orthopaedic implant standards . 3
4.2.3 Other implant standards . 5
4.3 Compositional specification and test method standards . 6
Bibliography . 9
© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/TR 17327-2:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery.
A list of all parts in the ISO 17327 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TR 17327-2:2021(E)
Introduction
Implant coatings have a broad range of functions and an innumerable variety of thicknesses,
compositions, densities, other properties and characteristics. Depending on the intended function, an
implant coating can be a highly important, potentially critical, component of the device’s overall design
or performance criteria, or both.
ISO 17327-1 provides an overview of generic coating properties, some of which are relevant to a
particular implant design and function in relation to its intended use. If these generic properties are
pertinent to a coating’s performance within its intended application, ISO 17327-1 requires the coating
to be assessed and potentially characterized to assure its proper function.
This document identifies International Standards and national documents that address requirements
for specific coating/substrate/product combinations. These reference standards contain guidance
on assessing and addressing the general coating requirements described in ISO 17327-1. The device-
specific implant reference standards provide guidance on the application of the characterization
requirements defined in ISO 17327-1. Likewise, general standards and material-specific standards
provide guidance on how to apply these characterizations as defined in ISO 17327-1.
This document provides tables that are grouped by generalized applications consistent with
ISO/TC 150. Each table contains lists of applicable reference standards and indicates their relationship
to the 10 properties introduced in ISO 17327-1. The relationship between the reference standard and
the property is defined as a description of a test methodology (TM), an indication of a requirement (R)
for evaluation, or a source of general information (GI) about the property. Additional footnotes provide
greater specificity of the relationship between the reference standard and the generalized property.
A reference standard with a (TM) designation describes a method by which the specific property can
be evaluated or applied.
A reference standard with an (R) designation contains a requirement regarding the specific property, or
that it is required to be evaluated, either to comply with design criteria or to complete a characterization
methodology.
A reference standard with a (GI) designation considers the specific property generally. It can indicate
that the reference standard requires or recommends the property to be characterized under only
specific circumstances. It can also indicate that the reference standard requires or recommends the
design attributes to meet their intended performance in the context of the property, but no methodology
or performance requirement is otherwise given.
NOTE The purpose of Tables 1 through 5 is to point to reference standards related to coatings and to provide
an initial impression of the relevant content included in these documents. However, the information contained
in the tables is not exhaustive and this initial impression will not be sufficient to evaluate if any of the reference
standards are relevant for a specific coating or device. This information is offered as a starting point, while the
documents themselves offer detailed content.
© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
TECHNICAL REPORT ISO/TR 17327-2:2021(E)
Non-active surgical implants — Implant coating —
Part 2:
Reference standards related to coatings
1 Scope
This document provides lists of reference standards which contain general information, implant device
or application-specific information, material specifications, or test methods related to coatings. These
reference standards can be used to develop product coatings for specified applications when using
ISO 17327-1 to address general coating requirements.
This document is applicable to coatings on non-active surgical implants.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Reference standards for coatings
4.1 General standards
Table 1 contains references to applicable general standards and indicates their relationship to the 10
properties introduced in ISO 17327-1.
© ISO 2021 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO/TR 17327-2:2021(E)
Table 1 — General standards
ISO 10993-18 TM, R GI
e
ISO/TR 14283 GI GI GI
d
ASTM F86 GI
d
ASTM F1801 R R TM
e
ASTM F1877 TM, R TM
h d
ASTM F2129 GI R , TM
e e
ASTM F2847 TM, R GI TM , R
d b,d,h
TM , R ,
ASTM F3044 R
h
GI
Key
GI General information
TM Test method
R Requirement
______________________________________________
a
Chemical ratio required.
b
Colour.
c
Density.
d
Corrosion.
e
Particle sizing.
f
Dissolution.
g
Surface discontinuity evaluation.
h
Surface area.
i
Thermal properties.
j
Hardness/surface modulus.
k
Electrical properties.
4.2 Implant-related standards
4.2.1 Cardiovascular implant standards
Table 2 contains references to applicable cardiovascular implant standards and indicates their
relationship to the 10 properties introduced in ISO 17327-1.
2 © ISO 2021 – All rights reserved
Reference standard
Chemical
composition
Phase composition
Surface texture
Coating integrity
Dissolvability
Coating thickness
Adhesion strength
Abrasion resistance
Porosity and
pore size
Surface wettability
Other
---------------------- Page: 7 ----------------------
ISO/TR 17327-2:2021(E)
Table 2 — Cardiovascular implant standards
d
ISO 5840-1 GI GI GI GI GI GI GI GI
d d
ISO 5840-2 R , TM
d,e
ISO 5840-3 GI GI
d,e k
ISO 5910 GI R , GI
e
ISO 7198 R R R, GI R
d g
ISO 10555-1 R TM , R
d g
ISO 11070 R, TM TM , R
c,d,e,i
R R ,
ISO 12417-1 R GI R R R R
d,e
TM
d,e
ISO/TS 17137 R GI
ISO
d d
R R , TM
l
25539-1
c,d e
ISO 25539-2 R, TM GI R R, TM R, TM R GI , R
d d
ISO 25539-3 R , TM
m
ISO 25539-4
ASTM F2394 GI, R,
TM
b
ASTM F2902 GI GI GI GI GI
e
ASTM F2743 GI GI TM TM
Key
GI General information
TM Test method
R Requirement
______________________________________________
a
Chemical ratio required.
b
Colour.
c
Density.
d
Corrosion.
e
Particle sizing.
f
Dissolution.
g
Surface discontinuity evaluation.
h
Surface area.
i
Thermal properties.
j
Hardness/surface modulus.
k
Electrical properties.
l
ISO 25539-4 clarifies which characterization requirements are applicable to cardiovascular implant coatings.
m
Applies to coatings, e.g. drug coatings (eluting and non-eluting); non-drug coatings (absorbable and non-absorbable); and
intentionally manufactured chemistry-related surface modifications that are not the natural surface; oxide (e.g. TiO ) and non-oxide (e.g.
2
anodization, diamond-like carbon).
4.2.2 Orthopaedic implant standards
Table 3 contains references to applicable orthopaedic implant standards and indicates their relationship
to the 10 properties introduced in ISO 17327-1.
© ISO 2021 – All rights reserved 3
Reference
standard
Chemical com-
position
Phase composi-
tion
Surface texture
Coating
integrity
Dissolvability
Coating
thickness
Adhesion
strength
Abrasion
resistance
Porosity and
pore size
Surface
wettability
Other
---------------------- Page: 8 ----------------------
ISO/TR 17327-2:2021(E)
Table 3 — Orthopaedic implant standards
ISO 19227 GI GI
e
ISO 21534 R R GI
ISO 21536 GI R
l d
ISO/AWI 23089-1 TM
m d
ISO/DIS 23089-2 TM
d
ASTM F897 TM
d
ASTM F1357 R
d
ASTM F1378 R R
d
ASTM F1672 GI, R R
d
ASTM F1798 GI
d
ASTM F1801 R R TM
d
ASTM F2068 R GI R, TM R GI R
d
ASTM F2083 R R R
d
ASTM F2091 R R R R
h d
ASTM F2129 GI R , TM
d
ASTM F2665 R R R
d
ASTM F2790 GI
d
ASTM F2887 R R R
b
ASTM F2902 GI GI GI GI GI
d b,d,h
TM R ,
ASTM F3044 R
h
GI
Key
GI General information
TM Test method
R Requirement
______________________________________________
a
Chemical ratio required.
b
Colour.
c
Density.
d
Corrosion.
e
Particle sizing.
f
Dissolution.
g
Surface discontinuity evaluation.
h
Surface area.
i
Thermal properties.
j
Hardness/surface modulus.
k
Electrical properties.
l
Under preparation. Stage at the time of publication: ISO/AWI 23089-1:— new project registered.
m
Under preparation. Stage at the time of publication: ISO/DIS 23089-2:2020.
4 © ISO 2021 – All rights reserved
Reference standard/
guidance document/
regulatory information
Chemical composition
Phase composition
Surface texture
Coating integrity
Dissolvability
Coating thickness
Adhesion strength
Abrasion resistance
Porosity and pore size
Surface wettability
Other
---------------------- Page: 9 ----------------------
ISO/TR 17327-2:2021(E)
Table 3 (continued)
U.S. FDA regulatory
d
information 946, R R R R R R GI
February 2000
U.S. FDA guidance docu-
GI GI
ment 1193, October 2000
U.S. FDA regulatory
information, February R, TM R, TM R, TM R, TM R, TM R, TM R, TM
1997
U.S. FDA guidance
d
R GI R, TM GI, R R
document, April 1994
U.S. FDA guidance
document 1418, January GI GI
2003
Key
GI General information
TM Test method
R Requirement
______________________________________________
a
Chemical ratio required.
b
Colour.
c
Density.
d
Corrosion.
e
Particle sizing.
f
Dissolution.
g
Surface discontinuity evaluation.
h
Surface area.
i
Thermal properties.
j
Hardness/surface modulus.
k
Electrical properties.
l
Under preparation. Stage at the time of publication: ISO/AWI
...
TECHNICAL ISO/TR
REPORT 17327-2
First edition
Non-active surgical implants —
Implant coating —
Part 2:
Reference standards related to
coatings
PROOF/ÉPREUVE
Reference number
ISO/TR 17327-2:2021(E)
©
ISO 2021
---------------------- Page: 1 ----------------------
ISO/TR 17327-2:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TR 17327-2:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Reference standards for coatings . 1
4.1 General standards . 1
4.2 Implant-related standards . 2
4.2.1 Cardiovascular implant standards . . 2
4.2.2 Orthopaedic implant standards . 3
4.2.3 Other implant standards . 5
4.3 Compositional specification and test method standards . 6
Bibliography . 9
© ISO 2021 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO/TR 17327-2:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery.
A list of all parts in the ISO 17327 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TR 17327-2:2021(E)
Introduction
Implant coatings have a broad range of functions and an innumerable variety of thicknesses,
compositions, densities, other properties and characteristics. Depending on the intended function, an
implant coating can be a highly important, potentially critical, component of the device’s overall design
or performance criteria, or both.
ISO 17327-1 provides an overview of generic coating properties, some of which are relevant to a
particular implant design and function in relation to its intended use. If these generic properties are
pertinent to a coating’s performance within its intended application, ISO 17327-1 requires the coating
to be assessed and potentially characterized to assure its proper function.
This document identifies International Standards and national documents that address requirements
for specific coating/substrate/product combinations. These reference standards contain guidance
on assessing and addressing the general coating requirements described in ISO 17327-1. The device-
specific implant reference standards provide guidance on the application of the surface characterization
requirements defined in ISO 17327-1. Likewise, general standards and material-specific standards
provide guidance on how to apply these characterizations as defined in ISO 17327-1.
This document provides tables that are grouped by generalized applications consistent with
ISO/TC 150. Each table contains lists of applicable reference standards and indicates their relationship
to the 10 properties introduced in ISO 17327-1. The relationship between the reference standard and
the property is defined as a description of a test methodology (TM), an indication of a requirement (R)
for evaluation, or a source of general information (GI) about the property. Additional footnotes provide
greater specificity of the relationship between the reference standard and the generalized property.
A reference standard with a (TM) designation describes a method by which the specific property can
be evaluated or applied.
A reference standard with an (R) designation contains a requirement regarding the specific property, or
that is it required to be evaluated, either to comply with design criteria or to complete a characterization
methodology.
A reference standard with a (GI) designation considers the specific property generally. It can indicate
that the reference standard requires or recommends the property to be characterized under only
specific circumstances. It can also indicate that the reference standard requires or recommends the
design attributes to meet their intended performance in the context of the property, but no methodology
or performance requirement is otherwise given.
NOTE The information contained in the tables in this document is not exhaustive. The tables provide the user
with suggestions for useful reference documents with an indication of the relevant content. This information is
offered as a starting point, while the documents themselves offer detailed content.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE v
---------------------- Page: 5 ----------------------
TECHNICAL REPORT ISO/TR 17327-2:2021(E)
Non-active surgical implants — Implant coating —
Part 2:
Reference standards related to coatings
1 Scope
This document provides lists of reference standards which contain general information, implant device
or application-specific information, material specifications, or test methods related to coatings. These
reference standards can be used to develop product coatings for specified applications when using
ISO 17327-1 to address general coating requirements.
This document is applicable to coatings on non-active surgical implants.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Reference standards for coatings
4.1 General standards
Table 1 contains references to applicable general standards and indicates their relationship to the 10
properties introduced in ISO 17327-1.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE 1
---------------------- Page: 6 ----------------------
ISO/TR 17327-2:2021(E)
Table 1 — General standards
ISO 10993-18 TM, R GI
e
ISO/TR 14283 GI GI GI
d
ASTM F86 GI
d
ASTM F1801 R R TM
e
ASTM F1877 TM, R TM
h d
ASTM F2129 GI R , TM
e e
ASTM F2847 TM, R GI TM , R
d b,d,h
TM , R ,
ASTM F3044 R
h
GI
Key
GI General information
TM Test method
R Requirement
______________________________________________
a
Chemical ratio required.
b
Colour.
c
Density.
d
Corrosion.
e
Particle sizing.
f
Dissolution.
g
Surface discontinuity evaluation.
h
Surface area.
i
Thermal properties.
j
Hardness/surface modulus.
k
Electrical properties.
4.2 Implant-related standards
4.2.1 Cardiovascular implant standards
Table 2 contains references to applicable cardiovascular implant standards and indicates their
relationship to the 10 properties introduced in ISO 17327-1.
2 PROOF/ÉPREUVE © ISO 2021 – All rights reserved
Reference standard
Chemical
composition
Phase composition
Surface texture
Coating integrity
Dissolvability
Coating thickness
Adhesion strength
Abrasion resistance
Porosity and pore
size
Surface wettability
Other
---------------------- Page: 7 ----------------------
ISO/TR 17327-2:2021(E)
Table 2 — Cardiovascular implant standards
d
ISO 5840-1 GI GI GI GI GI GI GI GI
d d
ISO 5840-2 R , TM
d,e
ISO 5840-3 GI GI
d,e k
ISO 5910 GI R , GI
e
ISO 7198 R R R, GI R
d g
ISO 10555-1 R TM , R
d g
ISO 11070 R, TM TM , R
c,d,e,i
R R ,
ISO 12417-1 R GI R R R R
d,e
TM
d,e
ISO/TS 17137 R GI
ISO
d d
R R , TM
l
25539-1
c,d e
ISO 25539-2 R, TM GI R R, TM R, TM R GI , R
d d
ISO 25539-3 R , TM
m
ISO 25539-4
ASTM F2394 GI, R,
TM
b
ASTM F2902 GI GI GI GI GI
e
ASTM F2743 GI GI TM TM
Key
GI General information
TM Test method
R Requirement
______________________________________________
a
Chemical ratio required.
b
Colour.
c
Density.
d
Corrosion.
e
Particle sizing.
f
Dissolution.
g
Surface discontinuity evaluation.
h
Surface area.
i
Thermal properties.
j
Hardness/surface modulus.
k
Electrical properties.
l
ISO 25539-4 clarifies which characterization requirements are applicable to cardiovascular implant coatings.
m
Applies to coatings, e.g. drug coatings (eluting and non-eluting); non-drug coatings (absorbable and non-absorbable); and
intentionally manufactured chemistry-related surface modifications that are not the natural surface; oxide (e.g. TiO ) and non-oxide (e.g.
2
anodization, diamond-like carbon).
4.2.2 Orthopaedic implant standards
Table 3 contains references to applicable orthopaedic implant standards and indicates their relationship
to the 10 properties introduced in ISO 17327-1.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE 3
Reference
standard
Chemical
composition
Phase
composition
Surface texture
Coating
integrity
Dissolvability
Coating
thickness
Adhesion
strength
Abrasion
resistance
Porosity and
pore size
Surface
wettability
Other
---------------------- Page: 8 ----------------------
ISO/TR 17327-2:2021(E)
Table 3 — Orthopaedic implant standards
ISO 19227 GI GI
e
ISO 21534 R R GI
ISO 21536 GI R
l d
ISO/AWI 23089-1 TM
m d
ISO/DIS 23089-2 TM
d
ASTM F897 TM
d
ASTM F1357 R
d
ASTM F1378 R R
d
ASTM F1672 GI, R R
d
ASTM F1798 GI
d
ASTM F1801 R R TM
d
ASTM F2068 R GI R, TM R GI R
d
ASTM F2083 R R R
d
ASTM F2091 R R R R
h d
ASTM F2129 GI R , TM
d
ASTM F2665 R R R
d
ASTM F2790 GI
d
ASTM F2887 R R R
b
ASTM F2902 GI GI GI GI GI
d b,d,h
TM R ,
ASTM F3044 R
h
GI
Key
GI General information
TM Test method
R Requirement
______________________________________________
a
Chemical ratio required.
b
Colour.
c
Density.
d
Corrosion.
e
Particle sizing.
f
Dissolution.
g
Surface discontinuity evaluation.
h
Surface area.
i
Thermal properties.
j
Hardness/surface modulus.
k
Electrical properties.
l
Under preparation. Stage at the time of publication: ISO/AWI 23089-1:— new project registered.
m
Under preparation. Stage at the time of publication: ISO/DIS 23089-2:2020.
4 PROOF/ÉPREUVE © ISO 2021 – All rights reserved
Reference standard/
guidance document/
regulatory information
Chemical
composition
Phase composition
Surface texture
Coating integrity
Dissolvability
Coating thickness
Adhesion strength
Abrasion resistance
Porosity and pore size
Surface wettability
Other
---------------------- Page: 9 ----------------------
ISO/TR 17327-2:2021(E)
Table 3 (continued)
U.S. FDA regulatory
d
information 946, R R R R R R GI
February 2000
U.S. FDA guidance docu-
GI GI
ment 1193, October 2000
U.S. FDA regulatory
information, February R, TM R, TM R, TM R, TM R, TM R, TM R, TM
1997
U.S. FDA guidance
d
R GI R, TM GI, R R
document, April 1994
U.S. FDA guidance
document 1418, January GI GI
2003
Key
GI General information
TM Test method
R Requirement
______________________________________________
a
Chemical ratio required.
b
Colour.
c
Density.
d
Corrosion.
e
Particle sizing.
f
Dissolution.
g
Surface discontinuity evaluation.
h
Surface area.
i
Thermal properties.
j
Hardness/surface modulus.
k
Electrical properties.
l
Under preparation. Stage at the time of publication: ISO/AWI 23089-1:— new project registered.
m
Under preparation. Stage at the time of publication: ISO/DIS
...
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