Document Center List of Standards on Laboratory Medicine
ICS Code 11.100
Return to ICS Index.Up to Level 1:
Down to Level 3:
- 11.100.01 (Laboratory medicine in general)
- 11.100.10 (In vitro diagnostic test systems)
- 11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
- 11.100.30 (Analysis of blood and urine Including doping control)
- 11.100.99 (Other standards related to laboratory medicine)
The following documents are a part of this series:
ASTM:
- ASTM-C1379 - Standard Test Method for Analysis of Urine for Uranium-235 and Uranium-238 Isotopes by Inductively Coupled Plasma-Mass Spectrometry (Withdrawn 2017)
- ASTM-C1473 - Standard Test Method for Radiochemical Determination of Uranium Isotopes in Urine by Alpha Spectrometry
- ASTM-D6499 - Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
- ASTM-E1044 - Standard Specification for Glass Serological Pipets (General Purpose and Kahn)
- ASTM-E1045 - Standard Specification for Pipet, Sahli Hemoglobin
- ASTM-E1046 - Standard Specification for Glass Westergren Tube, Disposable
- ASTM-E1047 - Standard Specification for Blood Sedimentation Tube, Wintrobe, Glass, Disposable
- ASTM-E1048 - Standard Specification for Pharmaceutical Glass Graduates
- ASTM-E1092 - Standard Specification for Glass Micro Folin Pipet, Disposable
- ASTM-E1103 - Standard Test Method for Determining Subchronic Dermal Toxicity (Withdrawn 2010)
- ASTM-E1246 - Standard Practice for Reporting Reliability of Clinical Laboratory Computer Systems (Withdrawn 2002)
- ASTM-E1365 - Practice for Conducting Static Acute Aquatic Toxicty Screening Tests With the Mosquito, Wyeomyia Smithii (Coquillett) (Withdrawn 1994)
- ASTM-E1380 - Standard Specification for Color Coding of Laboratory Pipets with Multiple Graduations, 0.1 mL and Larger, But Excluding Disposable Prothrombin and Disposable Micropipets
- ASTM-E1466 - Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory (Withdrawn 2002)
- ASTM-E1619 - Standard Test Method for Chronic Oral Toxicity Study in Rats
- ASTM-E1639 - Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems (Withdrawn 2002)
- ASTM-E1712 - Standard Specification for Representing Clinical Laboratory Test and Analyte Names (Withdrawn 2003)
- ASTM-E1768 - Standard Guide for Ventilatory Behavioral Toxicology Testing of Freshwater Fish (Withdrawn 2022)
- ASTM-E1811 - Standard Test Method for Oncogenicity Study in Rats and Mice (Withdrawn 2010)
- ASTM-E1843 - Standard Guide for Sexual Violence Investigation, Examination, and Evidence Collection Protocol
- ASTM-E1939 - Standard Practice for Blood Irradiation Dosimetry
- ASTM-E1969 - Standard Practice for Microcrystal Testing in Forensic Analysis for Methamphetamine and Amphetamine
- ASTM-E2146 - Standard Guide for Detection of Nucleic Acid Sequences of the Human Immunodeficiency Virus HIV-1 by the Polymerase Chain Reaction Technique (Withdrawn 2010)
- ASTM-E2328 - Standard Terminology Relating to Seized-Drug Analysis (Withdrawn 2005)
- ASTM-E714 - Standard Specification for Disposable Glass Serological Pipets
- ASTM-E732 - Standard Specification for Disposable Pasteur-Type Pipet
- ASTM-E733 - Standard Specification for 44.7-[mu]L Disposable Glass Micropipets (Withdrawn 2005)
- ASTM-E734 - Standard Specification for Disposable Glass Blood Sample Capillary Tube (Microhematocrit)
- ASTM-E787 - Standard Specification for Disposable Glass Micro Blood Collection Pipets
- ASTM-E788 - Standard Specification for Pipet, Blood Diluting
- ASTM-E890 - Standard Specification for Disposable Glass Culture Tubes
- ASTM-E923 - Standard Specification for Glass Westergren Tube, Reusable
- ASTM-E934 - Standard Specification for Serological Pipet, Disposable Plastic
- ASTM-E993 - Standard Test Method for Evaluation of Delayed Contact Hypersensitivity (Withdrawn 2010)
- ASTM-F1830 - Standard Practice for Selection of Blood for
in vitro Evaluation of Blood Pumps - ASTM-F1841 - Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
- ASTM-F1905 - Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)
- ASTM-F2103 - Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
- ASTM-F2147 - Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
- ASTM-F2148 - Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
- ASTM-F2151 - Standard Practice for Assessment of White Blood Cell Morphology After Contact with Materials (Withdrawn 2007)
- ASTM-F2382 - Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
- ASTM-F2386 - Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
- ASTM-F2450 - Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
- ASTM-F756 - Standard Practice for Assessment of Hemolytic Properties of Materials
BSI:
- BS-2554 - Specification for Westergren Tubes and Support for the Measurement of Erythrocyte Sedi
- BS-4851 - Specification for single use labelled medical specimen containers for haematology and biochemistry.
- BS-EN-12287 - In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological O
- BS-EN-13532 - General requirements for in vitro diagnostic medical devices for self-testing
- BS-EN-13612 - Performance evaluation of in vitro diagnostic medical devices
- BS-EN-13641 - Elimination or reduction of risk of infection related to in vitro diagnostic reagents
- BS-EN-13975 - Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
- BS-EN-375 - Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
- BS-EN-376 - Information Supplied by the Manufacturer With in Vitro Diagnostic Reagents for Self-Testin
- BS-EN-592 - Instructions for Use for in Vitro Diagnostic Instruments for Self-Testing
- BS-EN-928 - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
- BS-EN-ISO-10993-2 - Biological evaluation of medical devices
- BS-EN-ISO-10993-8 - Biological evaluation of medical devices
- BS-EN-ISO-20776-1 - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices
- BS-EN-ISO-6717 - In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
- BS-EN-ISO-6717-TC - Tracked Changes. In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
- BS-ISO-12771 - Plastics laboratory ware. Disposable serological pipettes
- BS-ISO-15190 - Medical laboratories. Requirements for safety
- DD-ISO-10993-19 - Biological evaluation of medical devices
- DD-ISO-10993-20 - Biological evaluation of medical devices
- PAS-93 - Characterization of human cells for clinical applications. Guide
ISO:
- ISO-10993-14 - Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
- ISO-10993-15 - Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
- ISO-10993-17 - Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
- ISO-10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO-10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- ISO-10993-8 - Biological evaluation of medical devices - Part 8: Selection and Qualification of Reference Materials for Biological Tests
- ISO-12771 - Plastics laboratory ware -- Disposable serological pipettes
- ISO-12772 - Laboratory glassware -- Disposable microhaematocrit capillary tubes
- ISO-14155-1 - Clinical investigation of medical devices for human subjects - Part 1: General requirements
- ISO-14155-2 - Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
- ISO-15190 - Medical laboratories - Requirements for safety
- ISO-15195 - Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures
- ISO-15198 - Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
- ISO-17511 - In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
- ISO-18153 - In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
- ISO-7713 - Laboratory glassware -- Disposable serological pipettes
- ISO/DIS-10993-18 - Part 18: Chemical Characterization of Materials - Biologicalevaluation of Medical Devices
- ISO/PAS-18873 - International protocol for doping control
Other SDOs:
- DIN-EN-13975 - Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
- DIN-EN-14254 - In Vitro Diagnostic Medical Devices, Single-Use Receptacles for the Collection of SPE
- DIN-EN-ISO-10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
- DIN-EN-ISO-10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012
- DIN-EN-ISO-10993-14 - Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009
- DIN-EN-ISO-10993-17 - Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2009
- DIN-EN-ISO-10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- DIN-EN-ISO-10993-8 - Part 8: Selection and Qualification of Reference Materials Forbiological Tests, Biologic
- DIN-EN-ISO-14155-2 - Part 2: Clinical Investigation Plans, Clinical Investigation of Medical Devices for Hu
- DIN-EN-ISO-15189 - Medical laboratories - Requirements for quality and competence
- EN-13975 - Sampling Procedures Used for Acceptance Testing of in Vitro Diagnostic Medical Device
- EN-14254 - In Vitro Diagnostic Medical Devices, Single-Use Receptacles for the Collection of SPE
- EN-ISO-20776-1 - Part 1: Reference Method for Testing the in Vitro Activity of Antimicrobial Agents AGA
- GB-19083 - Technical requirements for protective face mask for medical use (TEXT OF DOCUMENT IS IN ENGLISH)
- JIS-Z-2801 - Antibacterial products -- Test for antibacterial activity and efficacy
- SIS-EN-ISO-10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
- SS-EN-12286 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
- SS-EN-12287 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
- SS-EN-13503-5 - Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:1999, modified)
- SS-EN-13503-7 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2001, modified)
- SS-EN-13612 - Performance evaluation of in vitro diagnostic medical devices
- SS-EN-14136 - Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
- SS-EN-375 - Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
- SS-EN-376 - Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
- SS-EN-591 - Instructions for use for in vitro diagnostic instruments for professional use
- SS-EN-592 - Instructions for use for in vitro diagnostic instruments for self-testing
- SS-EN-829 - In vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements, tests
- SS-EN-ISO-10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)
- SS-EN-ISO-10993-9 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
- SS-EN-ISO-11979-5 - Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
- SS-EN-ISO-11979-7 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)
- SS-EN-ISO-14155-1 - Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
- SS-EN-ISO-17511 - In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
- SS-EN-ISO-20166-4 - Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques (ISO 20166-4:2021)
- SS-EN-ISO-6717 - In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)