ISO/FDIS 20579-3
(Main)Surface chemical analysis -- Sample handling, preparation and mounting
Surface chemical analysis -- Sample handling, preparation and mounting
Analyse chimique des surfaces -- Lignes directrices pour la manipulation, préparation et montage des échantillons
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FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 20579-3
ISO/TC 201/SC 2
Surface chemical analysis —
Secretariat: ANSI
Sample handling, preparation and
Voting begins on:
2020-11-03 mounting —
Voting terminates on:
Part 3:
2020-12-29
Biomaterials
Analyse chimique des surfaces — Lignes directrices pour la
manipulation, préparation et montage des échantillons —
Partie 3: Biomatériaux
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 20579-3:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 20579-3:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 20579-3:2020(E)
Contents Page
Foreword ........................................................................................................................................................................................................................................iv
Introduction ..................................................................................................................................................................................................................................v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 1
4 Symbols and abbreviated terms ........................................................................................................................................................... 2
5 Explanation of the structure of this documen ....................................................................................................................... 2
6 General requirements and classes of specimens ................................................................................................................ 3
6.1 General information ........................................................................................................................................................................... 3
6.2 Handling........................................................................................................................................................................................................ 3
6.3 Packaging ..................................................................................................................................................................................................... 3
6.4 Toxins and other hazardous materials ............................................................................................................................... 4
7 Specimen considerations ............................................................................................................................................................................. 4
7.1 History of the specimen .................................................................................................................................................................. 4
7.2 Information sought.............................................................................................................................................................................. 4
7.3 Categories of specimen .................................................................................................................................................................... 4
8 Sources of specimen contamination ................................................................................................................................................ 5
8.1 Sample preparation ............................................................................................................................................................................ 5
8.2 Tools ................................................................................................................................................................................................................. 5
8.3 Sample handling .................................................................................................................................................................................... 5
8.3.1 General...................................................................................................................................................................................... 5
8.3.2 Exposure to gases ............................................................................................................................................................ 5
8.3.3 Minimize contamination of the analysis area ......................................................................................... 5
8.4 Separation between neighbouring areas.......................................................................................................................... 6
9 Specimen storage and transfer of biomaterials ................................................................................................................... 6
9.1 Storage ........................................................................................................................................................................................................... 6
9.1.1 Storage time ......................................................................................................................................................................... 6
9.1.2 Descriptive list of containers for biomaterials ....................................................................................... 6
9.2 Temperature and humidity .......................................................................................................................................................... 6
10 Education of specimen owner on appropriate specimen handling procedures ................................6
11 Specimen mounting procedures of biomaterials ............................................................................................................... 6
12 Methods for reducing specimen charging .................................................................................................................................. 6
13 Specimen preparation techniques of biomaterials .......................................................................................................... 7
13.1 Mechanical separation...................................................................................................................................................................... 7
13.2 Sectioning techniques ....................................................................................................................................................................... 7
13.3 Solvents for biomaterials ............................................................................................................................................................... 7
13.4 Chemical etching ................................................................................................................................................................................... 7
13.5 Ion sputtering........................................................................................................................................................................................... 7
14 Fracturing, cleaving and scribing ........................................................................................................................................................ 7
15 Specimen-handling techniques ............................................................................................................................................................. 7
Bibliography ................................................................................................................................................................................................................................ 8
© ISO 2020 – All rights reserved iii---------------------- Page: 3 ----------------------
ISO/FDIS 20579-3:2020(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 201, Surface chemical analysis, Subcommittee SC
2, General procedures.A list of all parts in the ISO 20579 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 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 20579-3:2020(E)
Introduction
0.1 Common introduction
The ISO 20579 series is intended to assist analysts and those seeking surface chemical analysis in the
handling, storage, mounting and treatment of specimens. This is a multipart series, with the first two
parts being general requirements for (ISO 20579-1) sample handling and storage, and (ISO 20579-2)
mounting and treatment of samples. The ensuing parts combine any new requirements of sample
handling/storage and/or sample mounting/preparation for classes of new materials. This document
focuses on biomaterials analysis and handling, and ISO 20579-4 focuses on reporting and handling
needs for nano-objects. Each part of this series can be used independently of the other parts, although
the general procedures described in ISO 20579-1 and ISO 20579-2 are applicable to a wide range of
materials and are not reproduced in detail in material-specific sections.Although primarily prepared for the surface-analysis techniques of Auger electron spectroscopy
(AES), X-ray photoelectron spectroscopy (XPS) and secondary ion mass spectrometry (SIMS), the
methods described in this series will also be applicable to many other surface-sensitive analytical
techniques such as ion-scattering spectrometry, low-energy electron diffraction and electron energy-
loss spectroscopy, where specimen handling can influence surface-sensitive measurements. AES, XPS
and SIMS are sensitive to surface layers that are typically a few nanometers in thickness. Such thin
layers may be subject to severe perturbations caused by specimen handling or surface treatments that
may be necessary prior to introduction into the analytical chamber. Proper handling and preparation of
specimens is particularly critical for dependable analysis. Improper handling of specimens can result in
alteration of the surface composition and unreliable data.0.2 ISO 20579-3 introduction
This document is specifically intended to assist analysts in the handling, preparation and mounting of
specimens submitted for surface chemical analysis of biomaterials. Applications of synthetic materials
in a body includes metals, ceramics, polymers, glasses, carbons and composite materials. Surface-
analysis techniques such as AES, XPS and SIMS were originally developed for the analysis of inorganic
materials, but the methods described in this document may also be applicable to biomaterials. Many
other surface-sensitive analytical techniques such as ion-scattering spectrometry, low-energy electron
diffraction and electron energy-loss spectroscopy can be applied for specimen analysis. A few examples
of biomaterial applications are artificial hip and knee joints, bone plates for fracture fixation, dental
implants, optical devices (intraocular lenses), heart valves and stents for cardiovascular systems, and
1,2membrane materials for guided tissue regeneration. More examples are discussed elsewhere .
Specimen handling can influence surface-sensitive measurements. Surface methods for chemical
analysis are sensitive to surface layers that are typically only a few nanometers in thickness. Such thin
4-7layers may be subject to severe perturbations caused by improper specimen handling or surface
treatments that may be necessary prior to introduction into the analytical chamber. Proper handling
and preparation of specimens is particularly critical for biomaterial analysis. Improper handling of
specimens can result in alteration of the surface composition and unreliable data.
Proper preparation and mounting of specimens is particularly critical for surface chemical analysis
of biomaterials. Improper preparation may result in the alteration of the surface composition and in
unreliable analyses. Specimens are handled carefully so that the introduction of spurious contaminants
is avoided or minimized. The goal prior to analysis is to preserve the state of the surface during
preparation and mounting so that the analysis remains representative of the original specimen. This
document describes methods that the surface analyst may need to use in order to minimize the effects
of specimen preparation when using any analytical method.In addition, the change of composition of the surface of a biomaterial before and after implantation may
be an issue related to contamination. It is intended to highlight general ideas about surface chemical
analysis, in particular solid surfaces but also soft surfaces, such as self-assembled monolayers (SAMs),
hydrogels, scaffolds and some polymers.© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 20579-3:2020(E)
Surface chemical analysis — Sample handling, preparation
and mounting —
Part 3:
Biomaterials
1 Scope
This document gives guidance on methods of handling, mounting and surface treatment for a biomaterial
specimen prior to surface chemical analysis. It is intended for the analyst as an aid in understanding the
specialized specimen-handling conditions required for analyses by the following techniques:
— X-ray photoelectron spectroscopy (XPS or ESCA);— secondary ion mass spectrometry (SIMS);
— Auger electron spectroscopy (AES).
The protocols presented are also applicable to other analytical techniques that are sensitive to surface
composition, such as:— attenuated total reflectance -Fourier transform infrared spectroscopy (ATR-FTIR);
— total reflection X-ray fluorescence (TXRF);— ultraviolet photoelectron spectroscopy (UPS).
The influence of vacuum conditions applied and the issue of contamination before and after analysis and
implantation, as well as issues related to contamination during analysis, will be addressed. Biomaterials
covered here are hard and soft specimens such as metals, ceramics, scaffolds and polymers.
This document does not cover such viable biological materials as cells, tissues and living organisms.
Other related topics not covered in this standard include: preparation of specimens for electron or light
microscopy.2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18115-1 and ISO 18115-2 and
the following apply.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/
3.1
biomaterial
material intended to interface with biological systems to evaluate, treat, augment or replace any tissue,
organ or function of the body© ISO 2020 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO/FDIS 20579-3:2020(E)
3.2
biological material
organic and/or mineral substances produced by living organisms (e.g. bone, skin, seashell, woods, and
cultured cells)4 Symbols and abbreviated terms
AES Auger electron spectroscopy
ATR-FTIR -FTIR aAttenuated Ttotal rReflection - Fourier tTransform iInfrared Sspectroscopy
ESCA electron spectroscopy for chemical analysisSIMSSEM secondary-ion mass spectrometry scanning electron microscopy
TXRFSIMS total reflection X-ray fluorescence spectroscopy secondary-ion mass spectrometry
UPSTXRF ultra-violet photoelectron spectroscopy total reflection X-ray fluorescence spectroscopy
XPSUPS X-ray photoelectron spectroscopy ultra-violet photoelectron spectroscopyXPS X-ray photoelectron spectroscopy
5 Explanation of the structure of this documen
ASTM E1829 - 14 and ASTM E1078 – 14 provide specific information on specimen preparation techniques
prior to surface analysis of materials, covering general considerations, mechanical separation, thinning
[1,2]versus removal of layers, removal from the substrate, and sectioning techniques . The growth of
overlayers, solvents, chemical etching as well as ion sputtering, and plasma etching followed by sample
heating and ultraviolet radiation is emphasized.— Clause 6 provides specific recommendations on specimen handling procedures necessary to
minimize contamination of the biomaterial specimen surface. Moreover, Clause 6 gives a series of
alternative specimen handling procedures based on maintaining increasing degrees of specimen
cleanliness during handling and transfer of the specimen to sto...
DRAFT INTERNATIONAL STANDARD
ISO/DIS 20579-3
ISO/TC 201/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-11-05 2019-01-28
Surface chemical analysis — Sample handling, preparation
and mounting —
Part 3:
Biomaterials
Analyse chimique des surfaces — Lignes directrices pour la manipulation, préparation et montage des
échantillons —Partie 3: Biomatériaux
ICS: 71.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 20579-3:2018(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2018
---------------------- Page: 1 ----------------------
ISO/DIS 20579-3:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 20579-3:2018(E)
Contents Page
Foreword ........................................................................................................................................................................................................................................iv
Introduction ..................................................................................................................................................................................................................................v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 2
4 Symbols and abbreviated terms ........................................................................................................................................................... 2
5 Explanation of the structure of this Committee Draft (International Standard) ..............................2
6 General requirements and classes of specimens ................................................................................................................ 3
6.1 General Information ........................................................................................................................................................................... 3
6.2 Handling........................................................................................................................................................................................................ 3
6.3 Packaging ..................................................................................................................................................................................................... 4
6.4 Toxins and other hazardous materials ............................................................................................................................... 4
7 Specimen considerations ............................................................................................................................................................................. 4
7.1 History of the specimen .................................................................................................................................................................. 4
7.2 Information sought.............................................................................................................................................................................. 5
7.3 Categories of specimen .................................................................................................................................................................... 5
8 Sources of specimen contamination ................................................................................................................................................ 5
8.1 Sample preparation ............................................................................................................................................................................ 5
8.2 Tools ................................................................................................................................................................................................................. 5
8.3 Sample handling .................................................................................................................................................................................... 5
8.3.1 Blowing the sample ....................................................................................................................................................... 5
8.3.2 Exposure to gases ............................................................................................................................................................ 6
8.3.3 Minimize contamination of the analysis area ......................................................................................... 6
8.4 Separation between neighbouring areas.......................................................................................................................... 6
9 Specimen storage and transfer of biomaterials ................................................................................................................... 6
9.1 Storage ........................................................................................................................................................................................................... 6
9.1.1 Storage time ......................................................................................................................................................................... 6
9.1.2 Descriptive list of containers for biomaterials ....................................................................................... 7
9.2 Temperature and humidity .......................................................................................................................................................... 7
10 Education of specimen owner on appropriate specimen handling procedures ................................7
11 Specimen mounting procedures of biomaterials ............................................................................................................... 7
12 Methods for reducing specimen charging .................................................................................................................................. 7
13 Specimen preparation techniques of biomaterials .......................................................................................................... 7
13.1 Mechanical separation...................................................................................................................................................................... 7
13.2 Sectioning techniques ....................................................................................................................................................................... 7
13.3 Solvents for biomaterials ............................................................................................................................................................... 8
13.4 Chemical etching ................................................................................................................................................................................... 8
13.5 Ion sputtering........................................................................................................................................................................................... 8
14 Fracturing, cleaving and scribing ........................................................................................................................................................ 8
15 Specimen-handling techniques ............................................................................................................................................................. 8
Bibliography ................................................................................................................................................................................................................................ 9
© ISO 2018 – All rights reserved iii---------------------- Page: 3 ----------------------
ISO/DIS 20579-3:2018(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 on 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 the following
URL: www .iso .org/iso/foreword .html.This document was prepared by Technical Committee 201, Surface Chemical Analysis, Subcommittee SC
2, General procedures.The International Standards, ISO 18116 and ISO 18117, are replaced and merged into one new
International Standard ISO 20579. Part 1 is a guide to handling, part 2 for preparation and mounting
of specimen, part 3 (this document) as a guide for biomaterials handling, preparation and mounting of
specimen for surface analysis, and part 4 as a guide for nano-objects history, preparation, handling and
mounting.iv © ISO 2018 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DIS 20579-3:2018(E)
Introduction
Common Introduction
This International Standard is intended to assist analysts and those seeking surface chemical analysis
in the handling, storage, mounting and treatment of specimens. This is a multipart document, with
the first two parts being general requirements for (Part 1) sample handling and storage, and (Part
2) mounting and treatment of samples. The ensuing parts combine any new requirements of sample
handling/storage and/or sample mounting/preparation for new materials classes. Part 3 focuses on
biomaterials analysis and handling, Part 4 focuses on reporting and handling needs for nano-objects.
Each part of this International Standard can be used independently of the other parts, although, the
general procedures described in Parts 1 and 2 are applicable to a wide range of materials and are not
reproduced in detail in materials specific sections.Although primarily prepared for the surface-analysis techniques of Auger electron spectroscopy (AES),
X-ray photoelectron spectroscopy (XPS) and secondary ion mass spectrometry (SIMS), the methods
described in this International Standard will also be applicable to many other surface-sensitive
analytical techniques such as ion-scattering spectrometry, low-energy electron diffraction and electron
energy-loss spectroscopy, where specimen handling can influence surface-sensitive measurements.
AES, XPS and SIMS are sensitive to surface layers that are typically a few nanometers in thickness.
Such thin layers may be subject to severe perturbations caused by specimen handling or surface
treatments that may be necessary prior to introduction into the analytical chamber. Proper handling
and preparation of specimens is particularly critical for dependable analysis. Improper handling of
specimens can result in alteration of the surface composition and unreliable data.
ISO 20579:— Part 3 IntroductionThis part of ISO 20579 is specifically intended to assist analysts in the handling, preparation and
mounting of specimens submitted for surface chemical analysis of biomaterials. Applications of
synthetic materials in a body includes metals, ceramics, polymers, glasses, carbons, and composite
materials Surface-analysis techniques such as Auger electron spectroscopy (AES), X-ray photoelectron
spectroscopy (XPS) and secondary-ion mass spectrometry (SIMS) were originally developed for the
analysis of inorganic materials, the methods described in this International Standard are also be
applicable to biomaterials. Many other surface-sensitive analytical techniques such as ion-scattering
spectrometry, low- energy electron diffraction and electron energy-loss spectroscopy can be applied
for specimen analysis. A few examples of biomaterials applications are artificial hip and knee joints,
bone plates for fracture fixation, dental in plants, optical devices (intraocular lenses), heart valves and
stents for cardiovascular systems as well as membrane materials for guided tissue regeneration. More
1,2examples are discussed elsewhere .
Specimen handling can influence surface-sensitive measurements. Surface methods for chemical
analysis are sensitive to surface layers that are typically only a few nanometers in thickness. Such thin
1-4layers may be subject to severe perturbations caused by improper specimen handling or surface
treatments that may be necessary prior to introduction into the analytical chamber. Proper handling
and preparation of specimens is particularly critical for biomaterials analysis. Improper handling of
specimens can result in alteration of the surface composition and unreliable data.
Proper preparation and mounting of specimens is particularly critical for surface chemical analysis
of biomaterials. Improper preparation may result in the alteration of the surface composition and
in unreliable analyses. Specimens have to be handled carefully so that the introduction of spurious
contaminants is avoided or minimized. The goal prior to analysis is to preserve the state of the surface
during preparation and mounting so that the analysis remains representative of the original specimen.
This International Standard describes methods that the surface analyst may need to use in order to
minimize the effects of specimen preparation when using any.In addition, the change of composition of the surface of a biomaterial before and after implantation may
be an issue related to contamination. It is intended to highlight general ideas about surface chemical
analysis, in particular solid but also soft surfaces, such as self-assembled monolayers (SAMs), hydrogels,
scaffolds, and some polymers.© ISO 2018 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO/DIS 20579-3:2018(E)
All the treatment and handling of biomaterials should be followed the local laws such as Federal Food,
Drug, and Cosmetic Act (USA), Medicines Act 1968 (UK), Arzneimittelgesetz (Germeny) Pharmaceutical
Affairs Act (Japan).vi © ISO 2018 – All rights reserved
---------------------- Page: 6 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 20579-3:2018(E)
Surface chemical analysis — Sample handling, preparation
and mounting —
Part 3:
Biomaterials
1 Scope
This part 3 of the International Standard gives guidance on methods of handling, mounting and surface
treatment for a biomaterial specimen prior to surface chemical analysis. It is intended for the analyst
as an aid in understanding the specialized specimen-handling conditions required for analyses by
techniques as follows,— X-ray Photoelectron Spectroscopy (XPS or ESCA)
— Secondary Ion Mass Spectrometry (SIMS)
— Auger Electron Spectroscopy (AES).
The protocols presented is also applicable to other analytical techniques that are sensitive to surface
composition such as,— Attenuated Total Reflectance FTIR (ATR- FTIR),
— Total Reflection X-ray Fluorescence (TXRF),
— Ultraviolet Photoelectron Spectroscopy (UPS).
In particular instances, with particular specimens, further precautions for handling should be
necessary. Biomaterials are hard and soft materials as metals or bones on one hand or polymers,
hydrogels or scaffolds on the other hand.The influence of vacuum conditions applied as well as the issue of contamination before and after
analysis and implantation as well as issues related to contamination during analysis will be addressed.
Biomaterials covered here are hard and soft specimens such as metals, ceramics, scaffolds or polymers.
Soft materials need a different handling or sample preparation than hard materials.
Preparing whole mounts of biological specimens for imaging macromolecular structures by light and
electron microscopy is reported in Mathieu et al . A novel technique for preparation and analysis of
the implant surface and its interface to bone is described in Gilmore et al . Focused ion beam and
transmission electron microscopy for the characterization in cross section of Titanium implant surfaces
is reported by Jarmar et al . However, this international Standard does not cover such viable biological
materials such as cells tissues and living organisms.2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.ISO 20579-1, Surface chemical analysis —Guidelines to sample handling, preparation and mounting —
Part1: Guide to handling of specimens prior to analysis© ISO 2018 – All rights reserved 1
---------------------- Page: 7 ----------------------
ISO/DIS 20579-3:2018(E)
ISO 20579-2, Surface chemical analysis —Guidelines to sample handling, preparation and mounting —
Part2: Guidelines to preparation and mounting of specimens prior to analysisISO 20579-4, Surface chemical analysis — Guidelines to sample handling, preparation and mounting —
Part 4: Reporting information related to the history, preparation, handling and mounting of nano-objects
prior to surface analysis3 Terms and definitions
For the purposes of this international standard, the terms and definitions given in ISO 18115 Parts
1and 2 regarding surface analysis apply along with the specific terms from the ISO/TS 80004- series of
standards and standards 13527 and 27687 listed below:3.1
Biomaterial
A Biomaterial is a material intended to interface with biological systems to evaluate, treat, augment or
replace any tissue, organ or function of the body. A biomaterial is a nonviable material used in a medical
device, intended to interact with biological systems . A biomaterial is a material that is specially
prepared and/or presented to exhibit bioacceptability and/or biocompatibility. (ISO 10993:2007,
ISO 22803:2004).3.2
Biological material
Biological materials are organic and/or mineral substances produced by living organisms (e.g. bone,
skin, seashell, woods, and cultured cells) (ISO 18458:2015).4 Symbols and abbreviated terms
AES Auger electron spectroscopy
AFM Atomic force microscopy
ATR -FTIR Attenuated Total Reflection - Fourier Transform Infrared Spectroscopy
ESCA electron spectroscopy for chemical analysis
SEM scanning electron microscopy
SIMS secondary-ion mass spectrometry
TXRF total reflection X-ray fluorescence spectroscopy
UPS ultra-violet photoelectron spectroscopy
XPS X-ray photoelectron spectroscopy
5 Explanation of the structure of this Committee Draft (International Standard)
— Section 6 provides
...
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