Inter American Accreditation Cooperation

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1 IAAC MANDATORY AND NON-MANDATORY APPLICATION FOR THE ASSESSMENT AND ACCREDITATION OF REFERENCE MATERIAL PRODUCERS CLASSIFICATION This document is classified as an IAAC Mandatory Document AUTHORIZATION Issue Nº: 02 Prepared by: Laboratories Subcommittee Date: March 2017 Revision Nº: 00 Approved by: General Assembly Issue Date: April 24, 2017 Application Date: Immediate Document number: IAAC MD 028/17 Name for Inquiries: IAAC Secretariat Contact Phone: +52 (55) AVAILABILITY Copies of this document in English and Spanish are available from the IAAC Secretariat and at the IAAC website. COPYRIGHT IAAC holds the copyright of this document and it may not be copied for resale. Original: English Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 1 of 19

2 TABLE OF CONTENTS Inter American Accreditation Cooperation 1. PURPOSE 2. INTRODUCTION 3 TERMINOLOGY 4. APPLICATIONS FOR THE ASSESSMENT AND ACCREDITATION OF REFERENCE MATERIAL PRODUCERS ANNEX 1 LIST OF ISO GUIDE 31 AND ISO GUIDE 34 REQUIREMENTS FOR A REFERENCE MATERIAL CERTIFICATE OR DOCUMENTATION ANNEX 2: CATEGORIES OF REFERENCE MATERIAL Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 2 of 19

3 1- PURPOSE Inter American Accreditation Cooperation The applications in this document have been developed to ensure a consistent approach to the assessment and accreditation of Reference Material Producers (RMPs). The term Reference Materials (RM) in this document will refer to both certified reference materials and non-certified reference materials 2- INTRODUCTION One of the key factors affecting laboratories capabilities to produce reliable test data is the availability of reference materials with property values that can be relied upon by their users. ISO Guide 34:2009 General requirements for the competence of reference material producers has been produced by ISO REMCO and contains criteria that can be used to assess the competence of Reference Material Producers (RMPs) so that laboratories can have confidence in the materials that RMPs produce. In 2004 and 2005 the ILAC General Assembly passed a resolution identifying the general approach that Accreditation Bodies (ABs) shall take when assessing and accrediting RMPs. Following are the ILAC GA resolutions related to the accreditation of RMPs. ILAC Resolution GA 8.11 approved in 2004 The General Assembly acknowledges that assessing the technical competence of bodies producing reference materials with assigned values is accreditation of a conformity assessment activity. ILAC Resolution GA 8.12 Approved in October 2004 The General Assembly resolves that accreditation of technically competent bodies producing reference materials with assigned values will be conducted against harmonized criteria based on ISO Guide 34 and ISO/IEC in combination. ILAC Resolution GA 9.28, approved in September 2005 Following 2004 ILAC GA resolutions 8.11 and 8.12 relating to accreditation of Reference Material Producers, the General Assembly resolves that the accreditation to ISO Guide 34 in combination with ISO/IEC be included under the current ILAC arrangement when appropriate procedures for this activity are developed and agreed by ILAC. After ILAC issued these resolutions ISO Guide 34 was revised in ISO Guide 34:2009 makes specific normative reference to ISO/IEC in several requirements of section 5 Technical and production requirements. ISO Guide 34:2009 also states that for test performed in the medical field, ISO may be used as the reference instead of ISO/IEC Therefore, accreditation to ISO Guide 34:2009 fulfills the purpose of ILAC resolutions GA 8.12 and As a result of this revision of ISO Guide 34, ILAC approved the following resolution in its 2012 General Assembly: ILAC Resolution GA As ISO Guide 34:2009 includes normative references to ISO/IEC and ISO 15189, the General Assembly resolves that accreditation of reference material producers is conducted in accordance with ISO Guide 34:2009 alone. This Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 3 of 19

4 resolution rescinds ILAC resolution In addition ILAC R6:07/2012 will be amended to reflect this decision. This document contains both mandatory applications and non-mandatory application for accreditation body (AB) signatories, or applicants for signatory status, to the IAAC MLA for accreditation of reference material producers. In ISO/IEC and in ISO Guide 34:2009 the term shall denotes a requirement and the term should denotes a guideline or recommendation. For mandatory applications, the term shall is used throughout this document to indicate those provisions which, reflecting the requirements of ISO/IEC 17011, have to be fulfilled. For mandatory applications the term should is used to indicate those applications which are provided by IAF/ILAC as the suggested means of meeting requirements. Accreditation bodies whose systems do not follow the IAF/ILAC provisions in Part 1 denoted by a should must be able to demonstrate to peer evaluation teams that their own systems meet the relevant clause of ISO/IEC and the IAF/ILAC provisions in an equivalent way. Mandatory applications are identified with the letter M followed with a reference number that incorporates the related requirements clause in ISO/IEC 17011, e.g. ISO/IEC 17011, clause is supported with clauses M to M of this document. In all cases a reference in the text of this document to "clause XXX" refers to a clause in ISO/IEC unless otherwise specified. Non-mandatory applications are identified with the letter N followed with a reference number that incorporates the related requirements clause in ISO/IEC 17011, e.g. ISO/IEC 17011, clause is supported with clause N of this document. In all cases a reference in the text of this document to "clause XXX" refers to a clause in ISO/IEC unless otherwise specified. The non-mandatory nature of the applications means peer evaluation teams shall not raise nonconformities or concerns against these guidance clauses, but may raise comments based on them. 3 TERMINOLOGY The terminology specified below is defined in ISO Guide 34:2009; it has been included here in order to facilitate the understanding and use of this document. 3.1 reference material producer RMP body (organization or company, public or private) that is fully responsible for project planning and management, assignment of and decision on property values and relevant uncertainties, authorization of property values and issue of the certificate or other statements for the reference materials it produces 3.2 subcontractor body (organization or company, public or private) that undertakes aspects of the processing, handling, homogeneity and stability assessment, characterization, storage or distribution of the reference material on behalf of the reference material producer, on a contractual basis, either paid or non-paid (see ISO Guide 34, clause 5.3.1) NOTE 1 Key tasks/aspects of the reference material production process which cannot Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 4 of 19

5 be performed by external parties are project planning, assignment and decision on property values and relevant uncertainties, authorization of property values and issuing of certificates or other statements for the reference materials. NOTE 2 The concept subcontractor is equivalent to the concept collaborator. NOTE 3 Advisors, who could be asked for recommendations, but who are not involved in decision making or the execution of any aspects mentioned in the definition above, are not considered as subcontractors. 3.3 production of a reference material all necessary activities and tasks leading to a reference material (certified or noncertified) supplied to customers NOTE Production of a reference material includes production planning, production control, material handling and storage, material processing (also referred to as manufacturing or preparation ), assessment of homogeneity and stability, issue of statements and post-distribution service of the reference materials. It can include characterization, assignment of property values and their uncertainties, authorization and issue of certificates for certified reference materials. 3.4 reference material RM material, sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement process NOTE 1 RM is a generic term. NOTE 2 Properties can be quantitative or qualitative (e.g. identity of substances or species). NOTE 3 Uses may include the calibration of a measurement system, assessment of a measurement procedure, assigning values to other materials, and quality control. NOTE 4 A single RM cannot be used for both calibration and validation of results in the same measurement procedure. NOTE 5 VIM has an analogous definition (ISO/IEC Guide 99:2007, 5.13), but restricts the term measurement to apply to quantitative values and not to qualitative properties. However, Note 3 of ISO/IEC Guide 99:2007, 5.13, specifically includes the concept of qualitative attributes, called nominal properties. [ISO Guide 30:1992/Amd.1:2008, definition 2.1] 3.5 certified reference material CRM reference material characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability NOTE 1 The concept of value includes qualitative attributes such as identity or sequence. Uncertainties for such attributes may be expressed as probabilities. NOTE 2 Metrologically valid procedures for the production and certification of reference materials are given in, among others, ISO Guides 34 and 35. NOTE 3 ISO Guide 31 gives guidance on the contents of certificates. NOTE 4 VIM has an analogous definition (ISO/IEC Guide 99:2007, 5.14). [ISO Guide 30:1992/Amd.1:2008, definition 2.2] Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 5 of 19

6 4. APPLICATIONS FOR THE ASSESSMENT AND ACCREDITATION OF REFERENCE MATERIAL PRODUCERS M ISO Guide 34:2009 shall be the requirement for accreditation of reference material producers. ISO Guide 34:2009 makes normative reference to ISO/IEC in specific clauses. ISO Guide 34:2009 also states that for test in the medical field, ISO may be used as the reference instead of ISO/IEC ISO Guide 34:2009 makes normative reference in specific clauses to ISO Guide 31 and ISO Guide 35. In some cases ISO Guide 34:2009 uses the term shall while ISO Guide 31 or ISO Guide 35 use the term should or other terms for guidance for the same specific aspect of production of a reference material; in those cases the requirement established in ISO Guide 34:2009 supersedes and replaces the guidance or recommendation given in ISO Guide 31 or ISO Guide 35. ISO Guide 34:2009 requires certified reference material certificates to comply with the requirements of ISO Guide 31. ISO Guide 31 has many should statements or other types of guidelines, however these guidelines may be considered on a case by case basis as requirements where they are fundamental to the application and technical validity of the certified reference material. In order to facilitate the assessment of an RMP Annex 1 contains a list of all clauses on ISO Guide 31 and ISO Guide 34 that contain requirements for a reference material certificate or documentation. ISO Guide 34 makes normative reference to ISO Guide 35 in several clauses.. However ISO Guide 35 provides guidance in several clauses and allows for the uses of other approaches as clarified in its Introduction: Extract from ISO Guide 35:2006, Introduction: The approaches described in this Guide are not intended to be comprehensive in every respect of the production of an RM and the establishment of its property values, including the associated uncertainties. The approaches given in this Guide can be regarded as mainstream approaches for the production and value assignment of large groups of RMs, but appropriate amendments can be needed in a particular case. The statistical methods described exemplify the outlined approaches, and assume, e.g., normally distributed data. In particular when data are definitely not normally distributed, other statistical methods may be preferred to obtain valid property values and associated uncertainties. This Guide describes in general terms the design of projects to produce a CRM M The AB shall also investigate available technical standards for the production of specific reference material that need to be considered to support specific RMP accreditation programs (e.g. ISO 6141: Requirements for certificates for calibration gases and gas mixtures; ISO 6142: Gas analysis- Preparation of calibration gas mixtures Gravimetric method.) M The AB shall obtain information from the RMP that demonstrates how the RMP is organized and how it meets the relevant requirements of ISO Guide 34:2009. The information should include but not be limited to the following. Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 6 of 19

7 (i) The type or categories of RMs that are produced by the RMP. (ii) The technical standards that are used for the production of RMs. (iii) The activities performed by the RMP in relation to specific RMs. (iv) If the RMP uses a subcontractor, information about the subcontractors: Name and address of the subcontractor, The scope of activities performed by the subcontractor, including, the type of testing, calibration and measurement activities done by the subcontractor, Information about how the RMP assesses the competence of each subcontractor. N Table 1 provides some examples of how the tasks of RM production may be shared between the RMP and their subcontractor (where applicable). This table is offered for purposes of description and should not be considered to provide exhaustive coverage or to be all inclusive of every possible or probable RMP/subcontractor arrangement. Production activities Table 1 Responsible Organizations Type 1 Type 2 Type 3 Type 4 Type 5 Type 6 Type 7 Type Subcontractors R R R R R R R R 5.4 Production planning R R R R R R R R 5.5 Production control R R R S S R S R 5.7 Material handling and storage and 5.8 Material processing 5.13 Assessment of homogeneity and 5.14 Assessment of stability 5.13 Testing for assessment of homogeneity and 5.14 Testing for assessment of stability R S S S S R S R R R R R R R R R R R R S S S S R 5.15 Characterization R R R S S S R S 5.16 Assignment of property values and their uncertainties 5.17 Authorization of property values and issue of documentation or certificate R R R R R R R R R R R R R R R R 5.18 Distribution service R R S R S R S R Note: As per ISO Guide 34:2009, definitions 3.1, 3.2 and clause activities , 5.16 and 5.17 shall be done by the reference material producer. R = Tasks performed by the RMP S = Task performed by subcontractor M The assessment team appointment by the AB shall include adequately trained assessors who have relevant knowledge of the categories of (C)RMs produced and an Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 7 of 19

8 ability to cover the technical competency elements of an assessment based on ISO Guide 34, as well as the applicable requirements from ISO/IEC 17025, ISO 15189, ISO Guide 31 and ISO Guide 35. M The procedures for sampling of the scope shall ensure that the assessment team review a representative sample of CRM certificates and RM documentation during the assessment process to ensure proper evaluation of the competence of the CAB. M Key activities include: policy formulation, process and/or procedure development, contract review, production planning, assignment and decision on property values and relevant uncertainties, authorization of property values, issuing of certificates or other statements for the reference materials. M When planning the assessment, the AB shall take into account the different modes of operation that the RMP uses (e.g. see Table 1). in the assessment approach that is adopted. M If the RMP or the specified subcontractor is accredited to ISO/IEC or ISO by an IAAC and/or ILAC MRA signatory for the testing/calibration/measurement /examination activities it undertakes in the production of RMs, this accreditation can be considered satisfactory to meet the ISO/IEC or ISO M If the RMP is not accredited to ISO/IEC or ISO by an IAAC and/or ILAC MRA signatory for the testing/calibration/measurement/examination activities it undertakes in the production of RMs, but performs the testing/calibration/measurement/examination activities, the AB s assessment of the RMP shall include an assessment of the RMP s testing/calibration/ measurement/examination activities against the relevant parts of ISO/IEC or ISO M Where the RMP uses a subcontractor to perform the testing/calibration/ measurement/examination activities that does not hold ISO/IEC or ISO accreditation by an IAAC or ILAC MRA signatory for these activities, the AB shall assess how the RMP determines the competence of the subcontractor in accordance with the relevant parts of ISO/IEC or ISO The AB may determine that an on-site assessment of the subcontractor is necessary to directly assess its competence. M The certificate of accreditation shall state that the RMP meets the requirements of ISO Guide 34. M An AB shall provide a scope of accreditation that describes the specific types of certified reference materials and non-certified reference materials that the RMP is competent to produce. The scope of accreditation shall state the following: the category and/or subcategory of reference material (including the matrix) (see Annex 2); the property(ies) characterized; Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 8 of 19

9 ; the characterization technique(s); N It is recommended that the RMP scope of accreditation be based on the categories and sub-categories of RMs as provided in Annex 2. M Proficiency testing can be used to monitor the on-going competence of the testing and calibration processes. When the RMP performs testing/calibration or measurement that significantly affects the validity and uncertainty of the assigned property value of a RM, the RMP shall participate in the proficiency testing programs as required in ILAC P9 for the tests/calibrations and measurements it performs. When an accredited laboratory acts as a subcontractor, it shall also participate in proficiency testing programs, as required to meet ILAC P9 for the tests and calibrations it performs. A nonaccredited subcontractor shall similarly demonstrate competence through proficiency testing or other equivalent means. In situations where relevant PT is not available, the AB shall consider if the characterization process for candidate RM is adequate to demonstrate competence. M The AB shall require that it is informed by the accredited RMP without any delay if the arrangements between the RMP and any of the its subcontractors change during the accreditation period. The conditions shall stipulate that the RMP provide written details of provisions that are in place to assure continued technical competency and measures demonstrating that accreditation is being effectively maintained. M An RMP shall comply with the requirements for measurement traceability established in ILAC P10 for calibration laboratories, when it produces certified reference materials. Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 9 of 19

10 Annex 1 List of ISO Guide 31 and ISO Guide 34 Requirements for a Reference Material Certificate or Documentation Note: In case where the whole clause establishes requirements for certificate or documentation, just the clause number and, if applicable, the title are mentioned. Where the requirements is part of a broader requirement which covers aspects of the production of reference materials other the certificate or documentation, those relevant parts of the text of the ISO Guides are copied below. ISO Guide 31 Requirements 5.1 Some information is considered obligatory and shall always be provided, even though it may not be important in every case, e.g. the stability of a metal alloy or of the isotopic composition of natural compounds will rarely be questioned. 5.6 The presence of preservatives, such as mercury (II) chloride added to aqueous solutions of ethanol, shall also be stated. 5.8 It is essential that the reference material is used under the conditions prescribed in the certificate. For example, if drying is necessary the exact conditions, for example for 2h at 105 C, shall be stated. The nature of the solvent, temperature, mixing procedure, delay before use, and stability of the solution shall be carefully specified. It is essential to state the conditions under which the material shall be stored (e.g. temperature, exposure to light) in order to maintain the validity of the certificate Full details of the results from each method shall, in any case, be available from the producer in the form of a certification report or otherwise provided Names and signatures of certifying officers 6 Summary of the essential contents of a certificate ISO Guide 34 Requirements Although the measurement values do not have to be communicated to customers, the degree of homogeneity (e.g. expressed as maximum between-bottle variation) shall be indicated in the documentation accompanying the reference material Although the measurement values do not have to be communicated to customers, the degree of stability shall be indicated in the documentation accompanying the reference material Certificates or documentation for users Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 10 of 19

11 Annex 2 (Informative) CATEGORIES OF REFERENCE MATERIAL Introduction This Annex has been retained from the superseded ILAC G12 and is informative. ISO/TR 10989: Reference materials - Guidance on, and keywords used for, RM categorizations - also provides useful guidance on classification and categorization for reference materials. The list of reference material categories provided in this Annex has been derived following consideration of the existing entries in the reference material catalogues of bodies such as the National Institute of Standards and Technology (NIST), LGC, COMAR, and the European Community Bureau of Reference (BCR). The purpose of classifying reference materials is to enable the AB and the RMP to identify and define those types of material for which the producer has been found by assessment to be competent. It should be noted that that materials may fall into more than one category, and that classification is often better defined by reference to the intended use than by reference to the certified property. This Annex as well as ISO TR 10989:2009 can serve as good guidance in describing the specific types of RMs that an RMP is accredited to produce. Sub-categories may be required and can be included for clarity in the RMP s scope of accreditation. This information could be useful to the customers of the RMP. The System of Classification The principal headings or categories under which it is suggested that the reference materials are to be listed are: Category A: Chemical composition Reference materials, being either pure chemical compounds or representative sample matrices, either natural or with added analytes (e.g. animal fats spiked with pesticides for residues analysis), characterised for one or more chemical or physicochemical property values. Category B: Biological and clinical properties Materials similar to Category A, but characterised for one or more biochemical or clinical property values Category C: Physical properties Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 11 of 19

12 Materials characterised for one or more physical property values, e.g. melting point, viscosity, density. Category D: Engineering properties Materials characterised for one or more engineering property values (e.g. hardness, tensile strength, surface characteristics, etc). Category E: Miscellaneous These principal categories are sub-divided into sub-categories as indicated in the following draft list. It should be noted that these sub-categories are indicative only. Other subcategories can be added at any time to address the needs of applicants seeking recognition of competence in producing types of reference materials not currently listed. CATEGORY A: CHEMICAL COMPOSITION A1: METALS A1.1 Ferrous Steels carbon steels low alloy steels high alloy steels cast steels speciality steels gases in steels Irons white cast irons grey cast irons A1.2 Non-ferrous Aluminium base alloys Colbalt base alloys Copper base alloys Lead base alloys Nickel base alloys Tin base alloys Titanium base alloys Zinc base alloys Zirconium base alloys High purity metals Rare earth metals Refractory metals and alloys Special alloys Gases in non-ferrous A1.3 Special alloys A1.4 Refractory metals and alloys A1.5 Rare earth metals A1.6 High purity metals Solid forms Spectrochemical materials Spectrochemical solutions A2: INORGANIC REFERENCE MATERIALS Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 12 of 19

13 A2.1 Ores and minerals A2.2 Cements, clays and related products A2.3 Ceramics, glasses and refractory oxides Carbides Glasses A2.4 Agricultural chemicals and fertilisers A2.5 Solid fuels Coal and coke Mineral content Major elements Trace elements A2.6 Pure chemicals Stoichiometry standards Primary standards Working standards Secondary standards Chromatography standards Pharmaceutical materials Cosmetic materials A2.7 Stable isotope materials A3: ORGANIC REFERENCE MATERIALS A3.1 Pure organic compounds Compounds for elemental analysis Compounds for molecular weight Chromatography standards Illicit drugs and their metabolites - (See also A8 Forensic Reference Materials) Illicit drugs delta-9-thc and other cannabinoids amphetamine methylamphetamine 3,4-methylenedioxyamphetamine 3,4-methylenedioxy-methylamphetamine 3,4-methylenedioxyethylamphetamine diacetylmorphine morphine cocaine lysergic acid diethylamide and isomers Therapeutic drugs Veterinary drugs Steroids Pesticides, herbicides, acaricides, etc Metabolites of any of the above Priority pollutants PCBs, PAHs, etc Fine chemicals Pharmaceutical materials Cosmetic materials Isotopically labelled compounds Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 13 of 19

14 A3.2 Agricultural materials, fertilisers A3.3 Foodstuffs Proximate analysis Nutritional properties Vitamins Other food additives antioxidants emulsifiers Toxins animal origin plant origin other biological origin Trace elements Trace organics pesticide residues other organic contaminants A3.4 Plastics and rubbers Hardness Natural rubber content Identity copolymers plasticisers vulcanising agents blowing agents antioxidants fillers A3.5 Petroleum products Fuels and lubricants lead vanadium nickel Transformer oils moisture PCBs Heat exchange fluids moisture PCBs A3.6 Vegetable oils and fats Fatty acid profile Triglyceride composition A4: ENVIRONMENTAL REFERENCE MATERIALS A4.1 Soils and sludges Trace elements Mineral content Trace organics TCLP leachate Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 14 of 19

15 A4.2 Ashes Fly ash from coal and coke Incinerator ash A4.3 Waters Potable water routine analytes trace elements organic pollutants other analytes Fresh water major elements trace elements other analytes Sea water major elements trace elements other analytes Industrial waste water routine analytes trace elements organic pollutants other analytes Treated sewage routine analytes A4.4 Plant material Trace elements Mineral content Inter American Accreditation Cooperation A4.5 Marine Fish ) trace elements Molluscs ) mineral content Plankton ) organics A4.6 BOD reference compounds A4.7 Miscellaneous biological materials (e.g. Human hair) A5: HEALTH AND INDUSTRIAL HYGIENE A5.1 Clinical laboratory materials A5.2 Ethanol solutions A5.3 Toxic substances in urine Toxic metals Fluoride Mercury A5.4 Drugs of abuse in urine A5.5 Drugs of abuse in hair A5.6 Materials on filter media A5.7 Trace elements in blank filters A5.8 Lead in paint (powder and sheet forms) A5.9 Respirable silica Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 15 of 19

16 A6: ENGINE WEAR MATERIALS A6.1 Metallo-organic compounds A6.2 Wear metals in oil A7: REFERENCE GASES A7.1 Reference Gasmixtures A7.2 Ceritified gases A8: FORENSIC REFERENCE MATERIALS A8.1 Ethanol reference standards Ethanol Ethanol, aqueous solutions containing 0.050, 0.150, g/100ml A8.2 Drugs (individually named) and metabolites* In whole human blood and urine (*metabolites to include glucuronides). See also A3.1 Pure Organic Compounds. A8.3 Glasses Bottle Window Automotive Spectacle A8.4 Paints Automotive Architectural A8.5 Accelerants Flammable liquids and residues thereof A8.6 Explosives and primers A8.7 Gunshot residues A8.8 Noxious substances Crowd control agents capsaicin o-chlorobenzalmalononitrile (CS) chloroacetophenone (CN) A8.9 Document examination A9: ION ACTIVITY A9.1 ph standards A9.2 Ion selective electrode calibrants A9.3 Conductivity standards A9.4 Buffer systems CATEGORY B : BIOLOGICAL AND CLINICAL PROPERTIES B1 General Medicine B1.1 Human serum materials (powder and solution forms) B2 Clinical Chemistry B2.1 Proteins Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 16 of 19

17 B2.2 Apolipoproteins B2.3 Enzymes B2.4 Hormones B2.5 Trace elements lead and cadmium B3 Tissue Pathology B4 Haematology and Cytology B4.1 Blood serum B5 Immunohaematology B6 Immunology B7 Parasitology B8 Bacteriology and Mycology B8.1 Reference cultures B8.2 Antibiotics B9 Virology B10 Other biological and clinical reference materials B11 Forensic Reference Materials Purified DNA of known and continuing genetic composition Human, primate and animal blood Animal hairs Fibres (see also C7.1 to C7.3) CATEGORY C : PHYSICAL PROPERTIES C1 Reference Materials with Optical Properties C1.1 Optical rotation C1.2 Refractive index C1.3 Spectral absorbance visible ultraviolet infrared C1.4 Specular reflectance C1.5 Colour white reference material (opal glass) ceramic tiles C2 Reference Materials with Electrical and Magnetic Properties C2.1 Dielectric strength C2.2 Resistivity C2.3 Magnetic susceptibility C3 Reference Materials for Frequency Measurements C4 Reference Materials for Radioactivity C4.1 Radiation dosimetry C4.2 Radiopharmaceuticals C4.3 Labelled compounds C4.4 Natural matrix materials C4.5 Carbon-14 dating C5 Reference Materials for Thermodynamic Properties C5.1 Calorimetry C5.2 Thermal conductivity metals pyrex glass Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 17 of 19

18 resin-bonded fibre board C5.3 Vapour pressure C5.4 Thermal expansion C5.5 Thermal resistance C5.6 ITS-90 temperature fixed point C5.7 Curie point C5.8 Boiling point C5.9 Melting point C5.10 Thermal analysis standards C6 Reference Materials for Physicochemical Properties C6.1 Density C6.2 Viscosity C6.3 Surface tension C6.4 Molecular weight C7 Reference Materials for Fibre Identification C7.1 Natural fibres animal hairs plant fibres C7.2 Synthetic fibres organic polymers inorganic C7.3 Asbestos fibres crude fibres mounted specimens for fibre counting C8 Reference Materials for other properties C8.1 Shear testing of powders C8.2 Minerals for x-ray diffraction CATEGORY D : ENGINEERING PROPERTIES D1 Surface Finish D1.1 Surface roughness D1.2 Corrosion D1.3 Microhardness D1.4 Abrasive wear D1.5 Properties of films and surfaces Nominal thickness - x-ray fluorescence - B particle backscattering - ion beam sputtering D2 Sizing D2.1 Particle size Particulate materials Latex sphere suspensions D2.2 Surface area D3 Nondestructive Testing D3.1 Dye penetrant test blocks D3.2 Artificial flaw for eddy current D3.3 Magnetic particle inspection Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 18 of 19

19 D4 Hardness D4.1 Rockwell hardness D4.2 Izod hardness D5 Impact Toughness D5.1 Charpy V-notch test blocks D6 Tensile Strength D7 Elasticity D8 Creep D9 Fire Research D9.1 Surface flammability D9.2 Smoke density Inter American Accreditation Cooperation CATEGORY E : MISCELLANEOUS PROPERTIES (Sub-categories to be developed as required.) Date of Issue: April 24, 2017 IAAC MD 028/17 Pages 19 of 19