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| text      = This is sublevel8 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p>
|-
}}
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
 
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
==Sandbox begins below==
|-
Material testing can focus on specific industries (e.g., automotive, construction, and pharmaceutical), products (e.g., car seats, asphalt, and medical devices), or raw materials (e.g., steel, gravel, and zirconia ceramic).
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
About chemical testing of raw materials https://a2la.org/accreditation/chemical-testing/
[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />
 
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-1]<br />
Material testing domains:
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
* Aerospace
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.2]<br />
**Adhesives
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
**Composites
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
**Fasteners
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4]<br />
**Paints and primers
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
**Sealants
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, Appendix 1]
**Etc.
  | style="background-color:white;" |'''4.1''' The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
*Automotive
|-
**Adhesives
  | style="padding:5px; width:500px;" |
**Coatings
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-2]<br />
**Foams
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 1.2]
**Lighting and high-visibility solutions
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br />
**Plastics
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
**Seating
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
**Etc.
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<br />
*Carbon
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
**Activated carbon
  | style="background-color:white;" |'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.
**Coal tar
|-  
**Etc.
  | style="padding:5px; width:500px;" |
*Coatings, linings, and sealants
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
**Ceramic coatings
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
**Metal coatings
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
**Pipe linings
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
**Thermal sprays
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
**Etc.
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
*Construction and engineering
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-3]<br />
**Asphalt
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
**Brick and tile
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
**Fasteners
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
**Fenestration and glazing products (i.e., windows, doors, glass)
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />
**Geosynthetics
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
**Plumbing
[https://ichgcp.net/ ICH GCP 4.9.0 and 4.9.3]<br />
**Soil
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.2.3)]<br />
**Etc.
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.3.5]<br />
* Insulation, foam, and composites
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]<br />
**Fiberglass
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 4.12]
**Flexible and laminate urethane foam composite
  | style="background-color:white;" |'''4.3''' The system shall accurately maintain a full audit trail for modified results.
**Polyester resins
|-
**Etc.
  | style="padding:5px; width:500px;" |
*Lubricants and thickeners
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
**Metallic stearates
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.9.1]<br />
**Powdered metal
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 4.13]<br />
**Pre-formed grease thickeners
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br />
**Etc.
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories G15.1]<br />
* Medical devices
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3]<br />
**Ceramics
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12]<br />
**Metals
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4–5]<br />
**Screws
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-4]<br />
**Etc.
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
*Metals
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
**Aluminum
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br />
**Castings
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11]<br />
**Copper
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br />
**Rebar
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
**Steel
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
**Tubing
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
**Welds
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />
**Zinc
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />
**Etc.
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
* Packaging and labeling
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
**Cardboard
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10]<br />
**Label adhesives
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.1]<br />
**Pharmaceutical packaging
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1]
**Sterile barrier materials
  | style="background-color:white;" |'''4.4''' The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.
**Etc.
|-
* Paints and oils
  | style="padding:5px; width:500px;" |
**Interior/Exterior paints
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-5]<br />
**Organic coatings
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
**Paint on parts
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
**Transformer oil
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
**Etc.
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
* Paper
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<br />
**Cellulose paper tape
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
**Crepe paper and tubes
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, Appendix 1]
**Kraft paper
  | style="background-color:white;" |'''4.5''' The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.
**Pressboard
|-
**Etc.
  | style="padding:5px; width:500px;" |
*Polymers and plastics
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-6]<br />
**Biopolymers
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
**Condoms and gloves
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
**Payment cards
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]
**O-rings
  | style="background-color:white;" |'''4.6''' The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.
**[https://www.sciencedirect.com/science/article/pii/S1751616121005105 Silicone-based biological tissue mimics]
|- 
**Thermoplastic resins
  | style="padding:5px; width:500px;" |[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 4.0]<br />[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]
**Etc.
  | style="background-color:white;" |'''4.7''' The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.
* Raw materials
|-
**Food and beverage ingredients
|}
**Elemental material
|}
**Pharmaceutical ingredients
**Etc.
* Reference materials
**Cannabinoids
**Coals and cokes
**Elemental gasses
**Isotope reference material
**Organic analytical reference material
**Pesticides
**Etc.
*Rubbers
**Bump stops
**Gloves
**Neoprene
**Silicone
**Tires
**Etc.
*Electronics and energy devices
**Batteries
**Semiconductors
**Solar panels
**Transformers
**Etc.
*Textiles
**Carpet
**Drapery
**Non-woven fabrics
**Upholstery
**Etc.
*Wood
**Dowel
**Flooring
**Lumber
**Medium-density fibreboard (MDF)
**Etc.
 
Test method developers:
* Aerospace Industries Association (AIA/NAS/NASM)
* American Architectural Manufacturers Association (AAMA)
* American Association of State Highway and Transportation Officials (AASHTO)
* American Association of Textile Chemists and Colorists (AATCC)
* American Institute of Timber Construction (AITC)
* American National Standards Institute (ANSI)
* American Petroleum Institute (API)
* American Society of Mechanical Engineers (ASME)
* American Welding Society (AWS)
* American Wood Protection Association (AWPA)
* AOAC International (Association of Official Agricultural Chemists; AOAC)
* ASTM International (ASTM)
* Automakers (Ford, GM, Honda, PACCAR, Peugeot, Subaru, Tesla, Toyota, Volvo, etc.)
* Canadian Standards Association (CSA)
* Chemical Fabrics & Film Association (CFFA)
* Consumer Product Safety Commission (CPSC)
* Deutsches Institut für Normung (DIN)
* Electronic Components Industry Association (ECIA/EIA)
* European Telecommunications Standards Institute (ETSI)
* Federal Motor Vehicle Safety Standard (FMVSS)
* FM Approvals (FM)
* GE Aerospace (GE)
* Government and military (MIL, [https://fedspecs.gsa.gov/s/federal-standards Fed], Consumer Product Safety Commission, CSFA, EPA, FDA, MMM, NAVSEA, United Nations Economic Commission for Europe, etc.)
* Industrial Fasteners Institute (IFI)
* Institute of Electrical and Electronics Engineers (IEEE)
* International Atomic Energy Agency (IAEA) ([https://www.iaea.org/topics/material-analysis 1], [https://www.iaea.org/topics/other-non-destructive-testing 2], [https://www.iaea.org/topics/materials 3])
* International Code Council (ICC-ES)
* International Electrotechnical Commission (IEC)
* International Maritime Organization (IMO)
* International Organization for Standardization (ISO)
* International Safe Transit Association (ISTA)
* IPC International (Institute for Interconnecting and Packaging Electronic Circuits; IPC)
* Japanese Standards Association (JAS/JIS)
* NACE International (National Association of Corrosion Engineers; NACE)
* National Fire Protection Association (NFPA)
* [https://www.dot.ny.gov/divisions/engineering/structures/manuals/scm/repository/SCM_4th_Edition_1-2018.pdf New York State Steel Construction Manual (NNSSCM/SCM)]
* NSF International (National Sanitation Foundation; NSF)
* Pressure Sensitive Tape Council (PSTC)
* Radio Technical Commission for Aeronautics (RTCA)
* Suppliers of Advanced Composite Materials Association (SACMA)
* SAE International (SAE/AMS/AS)
* TAPPI (Technical Association of the Pulp and Paper Industry; TAPPI)
* Truss Plate Institute (TPI)
* UL Standards and Engagement (UL)
* United States Pharmacopeia Convention (USP)

Latest revision as of 18:07, 20 September 2023

This is sublevel8 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead.

Sandbox begins below

Material testing can focus on specific industries (e.g., automotive, construction, and pharmaceutical), products (e.g., car seats, asphalt, and medical devices), or raw materials (e.g., steel, gravel, and zirconia ceramic).

About chemical testing of raw materials https://a2la.org/accreditation/chemical-testing/

Material testing domains:

  • Aerospace
    • Adhesives
    • Composites
    • Fasteners
    • Paints and primers
    • Sealants
    • Etc.
  • Automotive
    • Adhesives
    • Coatings
    • Foams
    • Lighting and high-visibility solutions
    • Plastics
    • Seating
    • Etc.
  • Carbon
    • Activated carbon
    • Coal tar
    • Etc.
  • Coatings, linings, and sealants
    • Ceramic coatings
    • Metal coatings
    • Pipe linings
    • Thermal sprays
    • Etc.
  • Construction and engineering
    • Asphalt
    • Brick and tile
    • Fasteners
    • Fenestration and glazing products (i.e., windows, doors, glass)
    • Geosynthetics
    • Plumbing
    • Soil
    • Etc.
  • Insulation, foam, and composites
    • Fiberglass
    • Flexible and laminate urethane foam composite
    • Polyester resins
    • Etc.
  • Lubricants and thickeners
    • Metallic stearates
    • Powdered metal
    • Pre-formed grease thickeners
    • Etc.
  • Medical devices
    • Ceramics
    • Metals
    • Screws
    • Etc.
  • Metals
    • Aluminum
    • Castings
    • Copper
    • Rebar
    • Steel
    • Tubing
    • Welds
    • Zinc
    • Etc.
  • Packaging and labeling
    • Cardboard
    • Label adhesives
    • Pharmaceutical packaging
    • Sterile barrier materials
    • Etc.
  • Paints and oils
    • Interior/Exterior paints
    • Organic coatings
    • Paint on parts
    • Transformer oil
    • Etc.
  • Paper
    • Cellulose paper tape
    • Crepe paper and tubes
    • Kraft paper
    • Pressboard
    • Etc.
  • Polymers and plastics
  • Raw materials
    • Food and beverage ingredients
    • Elemental material
    • Pharmaceutical ingredients
    • Etc.
  • Reference materials
    • Cannabinoids
    • Coals and cokes
    • Elemental gasses
    • Isotope reference material
    • Organic analytical reference material
    • Pesticides
    • Etc.
  • Rubbers
    • Bump stops
    • Gloves
    • Neoprene
    • Silicone
    • Tires
    • Etc.
  • Electronics and energy devices
    • Batteries
    • Semiconductors
    • Solar panels
    • Transformers
    • Etc.
  • Textiles
    • Carpet
    • Drapery
    • Non-woven fabrics
    • Upholstery
    • Etc.
  • Wood
    • Dowel
    • Flooring
    • Lumber
    • Medium-density fibreboard (MDF)
    • Etc.

Test method developers:

  • Aerospace Industries Association (AIA/NAS/NASM)
  • American Architectural Manufacturers Association (AAMA)
  • American Association of State Highway and Transportation Officials (AASHTO)
  • American Association of Textile Chemists and Colorists (AATCC)
  • American Institute of Timber Construction (AITC)
  • American National Standards Institute (ANSI)
  • American Petroleum Institute (API)
  • American Society of Mechanical Engineers (ASME)
  • American Welding Society (AWS)
  • American Wood Protection Association (AWPA)
  • AOAC International (Association of Official Agricultural Chemists; AOAC)
  • ASTM International (ASTM)
  • Automakers (Ford, GM, Honda, PACCAR, Peugeot, Subaru, Tesla, Toyota, Volvo, etc.)
  • Canadian Standards Association (CSA)
  • Chemical Fabrics & Film Association (CFFA)
  • Consumer Product Safety Commission (CPSC)
  • Deutsches Institut für Normung (DIN)
  • Electronic Components Industry Association (ECIA/EIA)
  • European Telecommunications Standards Institute (ETSI)
  • Federal Motor Vehicle Safety Standard (FMVSS)
  • FM Approvals (FM)
  • GE Aerospace (GE)
  • Government and military (MIL, Fed, Consumer Product Safety Commission, CSFA, EPA, FDA, MMM, NAVSEA, United Nations Economic Commission for Europe, etc.)
  • Industrial Fasteners Institute (IFI)
  • Institute of Electrical and Electronics Engineers (IEEE)
  • International Atomic Energy Agency (IAEA) (1, 2, 3)
  • International Code Council (ICC-ES)
  • International Electrotechnical Commission (IEC)
  • International Maritime Organization (IMO)
  • International Organization for Standardization (ISO)
  • International Safe Transit Association (ISTA)
  • IPC International (Institute for Interconnecting and Packaging Electronic Circuits; IPC)
  • Japanese Standards Association (JAS/JIS)
  • NACE International (National Association of Corrosion Engineers; NACE)
  • National Fire Protection Association (NFPA)
  • New York State Steel Construction Manual (NNSSCM/SCM)
  • NSF International (National Sanitation Foundation; NSF)
  • Pressure Sensitive Tape Council (PSTC)
  • Radio Technical Commission for Aeronautics (RTCA)
  • Suppliers of Advanced Composite Materials Association (SACMA)
  • SAE International (SAE/AMS/AS)
  • TAPPI (Technical Association of the Pulp and Paper Industry; TAPPI)
  • Truss Plate Institute (TPI)
  • UL Standards and Engagement (UL)
  • United States Pharmacopeia Convention (USP)
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