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11.100 : Laboratory medicine 11 : Health care technology ICS
11.100 : Laboratory medicine
Items 1 to 200 of 899 total
NBN ISO 35001:2020
BS EN ISO 22367:2020
Medical laboratories. Application of risk management to medical laboratories
PD ISO/TS 10993-19:2020
Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization materials
BS ISO 15190:2020
Medical laboratories. Requirements for safety
PD ISO/TR 15499:2016:2020 + Redline
Tracked Changes. Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
BS EN ISO 22870:2016:2020 + Redline
Tracked Changes. Point-of-care testing (POCT). Requirements for quality and competence
BS EN ISO 15197:2015:2020 + Redline
Tracked Changes. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
BS EN ISO 23640:2015:2020 + Redline
Tracked Changes. In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 10993-6:2016:2020 + Redline
Tracked Changes. Biological evaluation of medical devices Tests for local effects after implantation
BS EN ISO 22442-1:2015:2020 + Redline
Tracked Changes. Medical devices utilizing animal tissues and their derivatives Application of risk management
BS EN ISO 22442-2:2015:2020 + Redline
Tracked Changes. Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection handling
20/30398724 DC:2020
BS EN ISO 10993-2. Biological evaluation of medical devices Part 2. Animal welfare requirements
20/30377819 DC:2020
BS EN ISO 10993-10. Biological evaluation of medical devices Part 10. Tests for skin sensitization
PD CEN/TS 17390-1:2020
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes circulating tumor cells (CTCs) venous whole blood Isolated RNA
PD CEN/TS 17390-2:2020
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes circulating tumor cells (CTCs) venous whole blood Isolated DNA
PD CEN/TS 17390-3:2020
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes circulating tumor cells (CTCs) venous whole blood Preparations analytical CTC staining
CEN/TS 17390-1:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA
1/24/2020 - PDF - English - NBN
CEN/TS 17390-2:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA
1/24/2020 - PDF - German - NBN
CEN/TS 17390-3:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining
UNE-EN ISO 20186-2:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)
XP ISO/TS 20914, S92-065 (01/2020)
UNE-EN ISO 20186-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
12/4/2019 - PDF - Spanish - AENOR
12/4/2019 - PDF - English - AENOR
NBN EN ISO 20186-3:2019
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)
BS EN ISO 20186-3:2019
Molecular in-vitro diagnostic examinations. Specifications for pre-examination processes venous whole blood Isolated circulating cell free DNA from plasma
PD ISO/TS 22583:2019
19/30381866 DC:2019
BS ISO 17822-2. In vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens Part 2. Laboratory quality practice guide
PR NF EN IEC 61326-2-6, C46-050-2-6PR (11/2019)
ASTM E1969-19
Standard Practice for Microcrystal Testing in Forensic Analysis for Methamphetamine and Amphetamine
ASTM E1969-19 + Redline
ASTM C1473-19
ASTM C1473-19 + Redline
19/30392968 DC:2019
BS EN 17444. Doping prevention in sport. Good development and manufacturing practices aimed at preventing the presence of prohibited substances in food intended for sports people and food supplements
UNE-EN ISO 20166-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018)
10/23/2019 - PDF - Spanish - AENOR
10/23/2019 - PDF - English - AENOR
UNE-EN ISO 20166-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018)
UNE-EN ISO 20166-3:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)
UNE-EN ISO 20184-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)
UNE-EN ISO 20184-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)
UNE-EN ISO 15195:2019
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
UNE-EN ISO 7405:2019
10/2/2019 - PDF - Spanish - AENOR
10/2/2019 - PDF - English - AENOR
ASTM E3231-19
Standard Guide for Cell Culture Growth Assessment of Single-Use Material
NF EN ISO 20186-3, S92-075-3 (10/2019)
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Cellular RNA - Part 3 : isolated circulating cell free DNA from plasma - Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus pré-analytiques pour le sang total veineux - Partie 3 : ADN libre circulant extrait du plasma
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice - Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude
ASTM F2212-19
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
ASTM F2212-19 + Redline
ASTM F1841-19
ASTM F1841-19 + Redline
ASTM F1830-19
Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps
ASTM F1830-19 + Redline
19/30361173 DC:2019
BS ISO 21474. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Part 1. Terminology and general requirements acid quality evaluation
PD ISO/TS 20914:2019
Medical laboratories. Practical guidance for the estimation of measurement uncertainty
8/5/2019 - PDF - English - BSI
PR NF EN ISO 10993-12, S99-501-12PR (07/2019)
PR NF EN ISO 10993-23, S99-501-23PR (07/2019)
Évaluation biologique des dispositifs médicaux - Partie 23 : Essais d'irritation
CLSI QMS01 -2019
6/19/2019 - - - CLSI
BS ISO 20916:2019
In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
ASTM F3352-19
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
19/30372368 DC:2019
BS EN ISO 10993-23. Biological evaluation of medical devices Part 23. Tests for irritation
19/30376763 DC:2019
BS EN ISO 10993-12. Biological evaluation of medical devices Part 12. Sample preparation and reference materials
BS EN ISO 20186-2:2019
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes venous whole blood Isolated genomic DNA
5/10/2019 - PDF - English - BSI
PR NF ISO 21151, S92-080PR (05/2019)
PR NF EN ISO 17511, S92-021PR (05/2019)
Dispositifs médicaux de diagnostic in vitro - Exigences pour l'établissement d'une traçabilité métrologique des valeurs attribuées aux étalons, aux matériaux de contrôle de la justesse et aux échantillons humains
NBN EN ISO 20186-1:2019
NBN EN ISO 20186-2:2019
PD CEN/TS 17305:2019
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
CEN/TS 17305:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
BS EN ISO 20186-1:2019
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes venous whole blood Isolated cellular RNA
4/2/2019 - PDF - English - BSI
PR NF EN ISO 22367, S92-081PR (04/2019)
Laboratoires de biologie médicale - Application de la gestion des risques aux laboratoires de biologie médicale
19/30378309 DC:2019
BS EN ISO 17511. In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
19/30378312 DC:2019
BS ISO 21151. In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples
NF EN ISO 20186-1, S92-075-1 (03/2019)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1 : isolated cellular RNA - Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus pré-analytiques pour le sang - ARN cellulaire - Partie 1 : ARN cellulaire extrait
NF EN ISO 20186-2, S92-075-2 (03/2019)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2 : isolated genomic DNA - Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus pré-analytiques pour le sang - ARN cellulaire - Partie 2 : ADN génomique extrait
NBN EN ISO 20166-3:2019
2/27/2019 - PDF - German - NBN
2/27/2019 - PDF - English - NBN
2/27/2019 - PDF - French - NBN
NBN EN ISO 15195:2019
BS EN ISO 20184-2:2018:2019
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes frozen tissue Isolated proteins
2/22/2019 - PDF - English - BSI
BS EN ISO 20166-1:2018:2019
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes formalin-fixed and paraffin-embedded (FFPE) tissue Isolated RNA
BS EN ISO 15195:2019
Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures
PD ISO/TS 21726:2019
Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
NF EN ISO 15195, S92-062 (02/2019)
PR NF EN ISO 22442-2, S97-601-2PR (02/2019)
ASTM F2888-19
Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
ASTM F2888-19 + Redline
NBN EN ISO 20166-2:2019
NBN EN ISO 20166-1:2019
NBN EN ISO 20184-1:2019
NBN EN ISO 20184-2:2019
BS EN ISO 20166-3:2019
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes formalin-fixed and paraffin-embedded (FFPE) tissue Isolated DNA
1/28/2019 - PDF - English - BSI
BS EN ISO 20166-2:2018:2019
Molecular in vitro diagnostic examinations. Specifications for pre-examinations processes formalin-fixed and paraffin-embedded (FFPE) tissue Isolated proteins
CLSI M100 :2019
1/1/2019 - PDF - English - CLSI
NF EN ISO 20166-3, S92-071-3 (01/2019)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3 : isolated DNA - Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus fixés au formol et inclus en paraffine (FFPE) - Partie 3: ADN extrait
UNE-EN ISO 10993-11:2018
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
BS EN ISO 20184-1:2018
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes frozen tissue Isolated RNA
NBN EN ISO 7405:2018
NF EN ISO 20166-1, S92-071-1 (12/2018)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1 : isolated RNA - Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus fixés au formol et inclus en paraffine (FFPE) - Partie 1 : ARN extrait
NF EN ISO 20166-2, S92-071-2 (12/2018)
Molecular in vitro diagnostic examinations Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2 : isolated proteins - Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus fixés au formol et inclus en paraffine (FFPE) - Partie 2: Protéines extraites
NF EN ISO 20184-1, S92-070-1 (12/2018)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1 : isolated RNA - Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus congelés - Partie 1: ARN extrait
NF EN ISO 20184-2, S92-070-2 (12/2018)
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2 : isolated proteins - Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus congelés - Partie 2: Protéines extraites
DIN EN ISO 22442-2:2018-12
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/DIS 22442-2:2018); German and English version prEN ISO 22442-2:2018
PR NF EN ISO 22442-1, S97-601-1PR (12/2018)
Standard Specification for Polysulfone Resin for Medical Applications
ASTM F702-18 + Redline
Standard Specification for Polycarbonate Resin for Medical Applications
ASTM F997-18 + Redline
BS EN ISO 7405:2018
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
18/30380349 DC:2018
BS ENISO 22442-2. Medical devices utilizing animal tissues and their derivatives Part 2. Controls on sourcing, collection handling
ASTM F2450-18
11/15/2018 - PDF - English - ASTM
ASTM F2450-18 + Redline
FD CEN/TR 17223, S99-212 (11/2018)
NF EN ISO 7405, S91-224 (11/2018)
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Médecine bucco-dentaire - Évaluation de la biocompatibilité des dispositifs médicaux utilisés en médecine bucco-dentaire
18/30377030 DC:2018
BS ISO 15190. Medical laboratories. Requirements for safety
10/22/2018 - PDF - English - BSI
PR NF EN ISO 10993-7/A1, S99-501-7/A1PR (10/2018)
DIN 58989:2018-10
Haemostaseology - HPLC-MS methods for the quantification of direct oral anticoagulants (DOAC) - Rivaroxaban; Text in German and English
ASTM F2382-18
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
ASTM F2382-18 + Redline
DIN EN ISO 22442-1:2018-09
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2018); German and English version prEN ISO 22442-1:2018
DIN EN ISO 10993-18:2018-09
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO/DIS 10993-18:2018); German and English version prEN ISO 10993-18:2018
DIN EN ISO 10993-11:2018-09
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
9/1/2018 - - - DIN
DIN 58909-1:2018-09
18/30355036 DC:2018
BS EN ISO 10993-7 AMD1. Biological evaluation of medical devices Part 7. Ethylene oxide sterilization residuals
8/16/2018 - PDF - English - BSI
18/30358832 DC:2018
BS EN ISO 10993-18. Biological evaluation of medical devices Part 18. Chemical characterization device materials within a risk management process
18/30375452 DC:2018
BS EN ISO 22442-1. Medical devices utilizing animal tissues and their derivatives Part 1. Application of risk management
DIN EN ISO 14155:2018-08
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2018); German and English version prEN ISO 14155:2018
DIN EN ISO 10993-7/A1:2018-08
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7:2008/DAM 1:2018); German and English version EN ISO 10993-7:2008/prA1:2018
PR NF EN ISO 20776-1, S92-053-1PR (08/2018)
Sensibilité in vitro des agents infectieux et évaluation des performances des dispositifs pour antibiogrammes - Partie 1 : Méthode de référence de microdilution en bouillon pour la détermination de la sensibilité in vitro aux agents antimicrobiens des bactéries aérobies à croissance rapide impliquées dans les maladies infectieuses
PR NF EN ISO 14155, S99-201PR (08/2018)
ASTM D6499-18
ASTM D6499-18 + Redline
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes snap frozen tissue Isolated DNA
CEN/TS 16826-3:2018
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA
7/20/2018 - PDF - English - NBN
18/30370871 DC:2018
BS EN ISO 20776-1. Susceptibility testing of infectious agents and evaluation performance antimicrobial susceptibility test devices Part 1. Broth micro-dilution reference method for the in vitro activity against rapidly growing aerobic bacteria involved diseases
NF EN ISO 10993-4, S99-501-4 (07/2018)
Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood - Evaluation biologique des dispositifs médicaux - Partie 4 : Choix des essais pour les interactions avec le sang
PR NF ISO 10993-15, S99-501-15PR (07/2018)
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys - Évaluation biologique des dispositifs médicaux - Partie 15 : Identification et quantification des produits de dégradation issus des métaux et alliages
7/1/2018 - Paper - English, French - AFNOR
18/30344902 DC:2018
BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
NBN EN ISO 10993-11:2018
BS EN ISO 10993-11:2018
6/18/2018 - PDF - English - BSI
PR NF EN ISO 10993-9, S99-501-9PR (06/2018)
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products - Évaluation biologique des dispositifs médicaux - Partie 9 : Cadre pour l'identification et la quantification des produits potentiels de dégradation
ASTM F2260-18
ASTM F2260-18 + Redline
ASTM F2103-18
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM F2103-18 + Redline
UNE-EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
18/30354689 DC:2018
BS EN ISO 10993-9. Biological evaluation of medical devices Part 9. Framework for identification and quantification potential degradation products
5/4/2018 - PDF - English - BSI
11.100.01 : Laboratory medicine in general
11.100.20 : Biological evaluation of medical devices
11.100.30 : Analysis of blood and urine
11.100.99 : Other standards related to laboratory medicine
AENOR (119)
AFNOR (98)