11 : Health care technology
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NBN EN ISO 10993-7:2008/A1:2022
Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid Sterilisationsrückstände - Änderung 1: Anwendbarkeit zulässiger Grenzwerte für Neugeborene und Kleinkinder (ISO 10993 7:2008/Amd 1:2019)
1/15/2022 - PDF - German - NBN
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22/30450431 DC:2022
BS EN 60601-2-57. Medical electrical equipment Part 2-57. Particular requirements for the basic safety and essential performance of non-laser light source intended therapeutic, diagnostic, monitoring cosmetic/aesthetic use
1/14/2022 - PDF - English - BSI
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BS EN IEC 60601-2-41:2021
Medical electrical equipment Particular requirements for the basic safety and essential performance of surgical luminaires diagnosis
1/12/2022 - PDF - English - BSI
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22/30426025 DC:2022
BS ISO 5227. Traditional Chinese Medicine. Safety controls of cupping device
1/11/2022 - PDF - English - BSI
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BS EN 60335-2-26:2003+A11:2020
Household and similar electrical appliances. Safety Particular requirements for clocks
1/10/2022 - PDF - English - BSI
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BS EN ISO 15223-1:2021 + Redline
Tracked Changes. Medical devices. Symbols to be used with information supplied by the manufacturer General requirements
1/4/2022 - PDF - English - BSI
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NF EN ISO 10993-7/A1, S99-501-7/A1 (01/2022)
Biological evaluation of medical devices - Part 7 : Ethylene oxide sterilization residuals - Amendment 1
1/1/2022 - Paper - French - AFNOR
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ASTM F3275-22
Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
1/1/2022 - PDF - English - ASTM
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ASTM F3275-22 + Redline
Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
1/1/2022 - PDF - English - ASTM
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ASTM F3276-22
Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
1/1/2022 - PDF - English - ASTM
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ASTM F3276-22 + Redline
Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
1/1/2022 - PDF - English - ASTM
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DIN CEN/TS 17626:2022-01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA, German version CEN/TS 17626:2021
1/1/2022 - PDF - German - DIN
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UNE-EN IEC 61010-2-040:2021
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (Endorsed by Asociación Española de Normalización in January of 2022.)
1/1/2022 - PDF - English - AENOR
Learn More€81.00 -
Pharmacopée Européenne 10th Edition 2022 - Bilingue Français/Anglais
Electronic version (10.3 –10.4 –10.5)
monoposte
1/1/2022 - Internet - English, French - EDQM
Learn More€574.00 -
€574.00
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€574.00
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€144.67
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DIN EN ISO 80601-2-85:2022-01
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021), German version EN ISO 80601-2-85:2021
1/1/2022 - PDF - German - DIN
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DIN EN ISO 80601-2-74:2022-01
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2021), German version EN ISO 80601-2-74:2021
1/1/2022 - PDF - German - DIN
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DIN EN ISO 6877:2022-01
Dentistry - Endodontic obturating materials (ISO 6877:2021), German version EN ISO 6877:2021
1/1/2022 - PDF - German - DIN
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UNE-CEN/TS 17500:2021
Quality of care and support for older persons (Endorsed by Asociación Española de Normalización in January of 2022.)
1/1/2022 - PDF - English - AENOR
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NF EN ISO 20776-2, S92-053-2 (01/2022)
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test - Part 2 : Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution - Systèmes d'essais en laboratoire et de diagnostic in vitro - Sensibilité in vitro des agents infectieux et évaluation des performances des dispositifs pour antibiogrammes - Partie 2 : Évaluation des performances des dispositifs pour antibiogrammes par rapport à une méthode de référence de
1/1/2022 - Paper - French - AFNOR
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UNE-CEN ISO/TS 16775:2021
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021) (Endorsed by Asociación Española de Normalización in January of 2022.)
1/1/2022 - PDF - English - AENOR
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UNE-EN ISO 9680:2021
Dentistry - Operating lights (ISO 9680:2021) (Endorsed by Asociación Española de Normalización in January of 2022.)
1/1/2022 - PDF - English - AENOR
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UNE-EN ISO 7711-1:2021
Dentistry - Diamond rotary instruments - Part 1: General requirements (ISO 7711-1:2021) (Endorsed by Asociación Española de Normalización in January of 2022.)
1/1/2022 - PDF - English - AENOR
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NF EN ISO 9713, S94-302 (01/2022)
Neurosurgical implants - Self-closing intracranial aneurysm clips
1/1/2022 - Paper - French - AFNOR
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ASTM F562-22
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
1/1/2022 - PDF - English - ASTM
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ASTM F562-22 + Redline
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
1/1/2022 - PDF - English - ASTM
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ASTM F2146-22
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
1/1/2022 - PDF - English - ASTM
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ASTM F2146-22 + Redline
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
1/1/2022 - PDF - English - ASTM
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ASTM F1671/F1671M-22
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
1/1/2022 - PDF - English - ASTM
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ASTM F1671/F1671M-22 + Redline
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
1/1/2022 - PDF - English - ASTM
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UNE-CEN/TS 14237:2021
Textiles for healthcare and social services facilities (Endorsed by Asociación Española de Normalización in January of 2022.)
1/1/2022 - PDF - English - AENOR
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ASTM E2597/E2597M-22
Standard Practice for Manufacturing Characterization of Digital Detector Arrays
1/1/2022 - PDF - English - ASTM
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ASTM E2597/E2597M-22 + Redline
Standard Practice for Manufacturing Characterization of Digital Detector Arrays
1/1/2022 - PDF - English - ASTM
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DIN 6868-1:2022-01
Image quality assurance in diagnostic X-ray departments - Part 1: General
1/1/2022 - PDF - German - DIN
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DIN 6868-15:2022-01
Image quality assurance in X-ray departments - Part 15: Constancy testing of X-ray installations for dental radiographic equipment for digital cone-beam computed tomography
1/1/2022 - PDF - German - DIN
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DIN 6868-14:2022-01
Image quality assurance in diagnostic X-ray departments - Part 14: Constancy testing of X-ray installations for digital mammography
1/1/2022 - PDF - German - DIN
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DIN 6868-152:2022-01
Image quality assurance in diagnostic X-ray departments - Part 152: Acceptance test of X-ray installations for screen/film mammography
1/1/2022 - PDF - German - DIN
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DIN 6868-162:2022-01
Image quality assurance in diagnostic X-ray departments - Part 162: Acceptance test of digital mammography installations
1/1/2022 - PDF - German - DIN
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DIN 6868-150:2022-01
Image quality assurance in diagnostic X-ray departments - Part 150: Acceptance test of medical radiographic and fluoroscopic X-ray equipment
1/1/2022 - PDF - German - DIN
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DIN 6868-157:2022-01
Image quality assurance in diagnostic X-ray departments - Part 157: X-ray ordinance acceptance and constancy test of image display systems in their environment
1/1/2022 - PDF - German - DIN
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DIN 6868-161:2022-01
Image quality assurance in diagnostic X-ray departments - Part 161: Acceptance testing of dental radiographic equipment for digital cone-beam computed tomography
1/1/2022 - PDF - German - DIN
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DIN 6859-1:2022-01
Image quality assurance in diagnostic laboratories - Part 1: Constancy testing of ultrasound equipment for medical diagnosis and monitoring
1/1/2022 - PDF - German - DIN
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ASTM F1127-22
Standard Guide for Containment of Hazardous Material Spills by Emergency Response Personnel
1/1/2022 - PDF - English - ASTM
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ASTM F1127-22 + Redline
Standard Guide for Containment of Hazardous Material Spills by Emergency Response Personnel
1/1/2022 - PDF - English - ASTM
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€68.00
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€81.60
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CEN/TS 17688-1:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
12/24/2021 - PDF - German - NBN
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CEN/TS 17688-1:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
12/24/2021 - PDF - English - NBN
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CEN/TS 17688-2:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins
12/24/2021 - PDF - English - NBN
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CEN/TS 17688-3:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA
12/24/2021 - PDF - English - NBN
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CEN/TS 17688-3:2021
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für Feinnadelaspirate - Teil 3: Isolierte genomische DNA
12/24/2021 - PDF - German - NBN
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CEN/TS 15209:2021
Tactile paving surface indicators produced from concrete, clay and stone
12/24/2021 - PDF - German - NBN
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CEN/TS 15209:2021
Tactile paving surface indicators produced from concrete, clay and stone
12/24/2021 - PDF - English - NBN
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CEN/TS 15209:2021
Surfaces tactiles d'indication au sol en béton, terre cuite et pierre naturelle
12/24/2021 - PDF - French - NBN
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PD CEN/TS 17688-2:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes Fine Needle Aspirates (FNAs) Isolated proteins
12/23/2021 - PDF - English - BSI
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PD CEN/TS 17688-1:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes Fine Needle Aspirates (FNAs) Isolated cellular RNA
12/23/2021 - PDF - English - BSI
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PD CEN/TS 17688-3:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes Fine Needle Aspirates (FNAs) Isolated genomic DNA
12/23/2021 - PDF - English - BSI
Learn More€293.00 -
€326.00
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21/30404455 DC:2021
BS EN ISO 22675. Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
12/23/2021 - PDF - English - BSI
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BS ISO 13179-1:2021 + Redline
Tracked Changes. Implants for surgery. Coatings on metallic surgical implants Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
12/23/2021 - PDF - English - BSI
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BS EN IEC 60601-2-1:2021 + Redline
Tracked Changes. Medical electrical equipment Particular requirements for the basic safety and essential performance of electron accelerators in range 1 MeV to 50
12/21/2021 - PDF - English - BSI
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21/30387349 DC:2021
BS EN ISO 13408-1. Aseptic processing of health care products Part 1. General requirements
12/17/2021 - PDF - English - BSI
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BS EN ISO 4307:2021 + Redline
Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
12/17/2021 - PDF - English - BSI
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IEC 81001-5-1:2021
IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
12/16/2021 - PDF - English, French - IEC
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21/30398248 DC:2021
BS EN ISO 3630-6. Dentistry. Endodontic instruments Part 6. Numeric coding system
12/16/2021 - PDF - English - BSI
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BS EN ISO 14971:2019+A11:2021
Medical devices. Application of risk management to medical devices
12/15/2021 - PDF - English - BSI
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ASTM F1980-21
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
12/15/2021 - PDF - English - ASTM
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ASTM F1980-21 + Redline
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
12/15/2021 - PDF - English - ASTM
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BS EN ISO 5832-3:2021 + Redline
Tracked Changes. Implants for surgery. Metallic materials Wrought titanium 6-aluminium 4-vanadium alloy
12/15/2021 - PDF - English - BSI
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ASTM E2280-21
Standard Guide for Fire Hazard Assessment of the Effect of Upholstered Seating Furniture Within Patient Rooms of Health Care Facilities
12/15/2021 - PDF - English - ASTM
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ASTM E2280-21 + Redline
Standard Guide for Fire Hazard Assessment of the Effect of Upholstered Seating Furniture Within Patient Rooms of Health Care Facilities
12/15/2021 - PDF - English - ASTM
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BS EN IEC 62244:2021 + Redline
Tracked Changes. Radiation protection instrumentation. Installed radiation portal monitors (RPMs) for the detection of illicit trafficking of radioactive and nuclear materials
12/14/2021 - PDF - English - BSI
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NBN EN ISO 14971:2019/A11:2021
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
12/11/2021 - PDF - French - NBN
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NBN EN ISO 14971:2019/A11:2021
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
12/11/2021 - PDF - German - NBN
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NBN EN ISO 14971:2019/A11:2021
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
12/11/2021 - PDF - English - NBN
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€348.00
-
BS EN ISO 17511:2021 + Redline
Tracked Changes. In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
12/10/2021 - PDF - English - BSI
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UNE-EN ISO 20417:2021
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
12/7/2021 - PDF - Spanish - AENOR
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UNE-EN ISO 20417:2021
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
12/7/2021 - PDF - English - AENOR
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BS EN IEC 61010-2-040:2021
Safety requirements for electrical equipment measurement, control, and laboratory use Particular sterilizers washer-disinfectors used to treat medical materials
12/7/2021 - PDF - English - BSI
Learn More€331.00 -
IEC 61223-3-7:2021
IEC 61223-3-7:2021 Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography
12/7/2021 - PDF - English, French - IEC
Learn More€311.00 -
21/30433033 DC:2021
BS EN IEC 80601-2-71. Medical electrical equipment Part 2-71. Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS)
12/7/2021 - PDF - English - BSI
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BS EN ISO 7711-1:2021 + Redline
Tracked Changes. Dentistry. Diamond rotary instruments General requirements
12/6/2021 - PDF - English - BSI
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€326.00
-
BS EN ISO 5832-3:2021
Implants for surgery. Metallic materials Wrought titanium 6-aluminium 4-vanadium alloy
12/6/2021 - PDF - English - BSI
Learn More€180.00 -
€184.00
-
€184.00
-
€121.00
-
€121.00
-
€121.00
-
NBN EN ISO 5832-3:2021
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
12/4/2021 - PDF - French - NBN
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NBN EN ISO 5832-3:2021
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
12/4/2021 - PDF - German - NBN
Learn More€58.00 -
NBN EN ISO 5832-3:2021
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
12/4/2021 - PDF - English - NBN
Learn More€58.00 -
NBN ISO 16840-10:2021
Wheelchair seating — Part 10: Resistance to ignition of postural support devices — Requirements and test method ISO 16840-10:2021 - Corrected version 2022-01
12/3/2021 - PDF - English - NBN
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NBN ISO 16840-13:2021
Wheelchair seating — Part 13: Determination of the lateral stability property of a seat cushion ISO 16840-13:2021
12/3/2021 - PDF - English - NBN
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21/30448951 DC:2021
BS IEC SRD 63314. AAL requirements for education and training of persons working in the field of AAL
12/3/2021 - PDF - English - BSI
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NBN ISO 23089-2:2021
Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements — Part 2: Spinal intervertebral body fusion devices ISO 23089-2:2021
12/3/2021 - PDF - English - NBN
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NBN ISO 8600-8:2021
Endoscopes — Medical endoscopes and endotherapy devices — Part 8: Particular requirements for capsule endoscopes ISO 8600-8:2021
12/3/2021 - PDF - English - NBN
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BS ISO 16840-12:2021
Wheelchair seating Envelopment and immersion characterization of seat cushions using a dual semispherical indenter
12/2/2021 - PDF - English - BSI
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NF EN ISO 14971/A11, S99-211/A11 (12/2021)
Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
12/1/2021 - Paper - French - AFNOR
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€46.00
-
€53.00
-
DIN EN ISO 13485:2021-12
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016), German version EN ISO 13485:2016 + AC:2018 + A11:2021
12/1/2021 - PDF - German - DIN
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UNE-EN IEC 80001-1:2021
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (Endorsed by Asociación Española de Normalización in December of 2021.)
12/1/2021 - PDF - English - AENOR
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UNE-EN IEC 80601-2-26:2020/AC:2021-10
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in December of 2021.)
12/1/2021 - PDF - English - AENOR
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DIN EN 285:2021-12
Sterilization - Steam sterilizers - Large sterilizers, German version EN 285:2015+A1:2021
12/1/2021 - PDF - German - DIN
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DIN EN ISO 6717:2021-12
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021), German version EN ISO 6717:2021
12/1/2021 - PDF - German - DIN
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UNE-EN ISO 16256:2021
Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021) (Endorsed by Asociación Española de Normalización in December of 2021.)
12/1/2021 - PDF - English - AENOR
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FD ISO/TR 21582, S99-513 (12/2021)
Pyrogénicité - Principes et méthodes d'essai pour la recherche des pyrogènes sur les dispositifs médicaux
12/1/2021 - Paper - French - AFNOR
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BS EN ISO 7711-1:2021
Dentistry. Diamond rotary instruments General requirements
12/1/2021 - PDF - English - BSI
Learn More€180.00 -
€250.00
-
€86.67
-
XP CEN ISO/TS 16775, S98-167 (12/2021)
Emballages des dispositifs médicaux stérilisés au stade terminal - Lignes directrices relatives à l'application de l'ISO 11607-1 et l'ISO 11607-2
12/1/2021 - Paper - French - AFNOR
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€377.00
-
NF ISO 7206-10/A1, S94-166-10/A1 (12/2021)
Implants for surgery - Partial and total hip-joint prostheses - Part 10 : Determination of resistance to static load of modular femoral heads - Amendment 1
12/1/2021 - Paper - French - AFNOR
Learn More€25.67 -
NF EN ISO 5832-3, S94-051-3 (12/2021)
Implants for surgery - Metallic materials - Part 3 : wrought titanium 6-aluminium 4-vanadium alloy
12/1/2021 - Paper - French - AFNOR
Learn More€48.00 -
NF ISO 13179-1, S94-169-1 (12/2021)
Implants for surgery - Coatings on metallic surgical implants - Part 1 : plasma-sprayed coatings derived from unalloyed titanium and TiAl6V4 powders
12/1/2021 - Paper - French - AFNOR
Learn More€48.00 -
ASTM F1377-21
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
12/1/2021 - PDF - English - ASTM
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ASTM F1377-21 + Redline
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
12/1/2021 - PDF - English - ASTM
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DIN ISO 15309:2021-12
Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices (ISO 15309:2013)
12/1/2021 - PDF - German - DIN
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UNE-EN 50527-2-3:2021
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-3: Specific assessment for workers with implantable neurostimulators (Endorsed by Asociación Española de Normalización in December of 2021.)
12/1/2021 - PDF - English - AENOR
Learn More€138.00 -
NF EN IEC 60601-2-41, C74-325 (12/2021)
Medical electrical equipment - Part 2-41 : Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
12/1/2021 - Paper - French - AFNOR
Learn More€170.00 -
XP CEN/TS 14237, G33-004 (12/2021)
Textiles dans les établissements de santé et de services sociaux
12/1/2021 - Paper - French - AFNOR
Learn More€75.67 -
NF EN IEC 62563-2, C74-236-2 (12/2021)
Appareils électromédicaux - Systèmes d'imagerie médicale - Partie 2 : essais d'acceptation et de constance des systèmes d'imagerie médicale
12/1/2021 - Paper - French - AFNOR
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DIN 6864-1:2021-12
Constancy test of the radiation therapy chain - Part 1: Teletherapy
12/1/2021 - PDF - German - DIN
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DIN/TS 58194:2021-12
Ophthalmic optics - Terms and definitions related to free-form technology, Text in German and English
12/1/2021 - PDF - English, German - DIN
Learn More€73.93 -
NF U47-027 (12/2021)
Animal health analysis methods - Detection of antibodies against mucosal disease by virus neutralisation test and immunochemistry on cell cultures (IF or IP)
12/1/2021 - Paper - French - AFNOR
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21/30415192 DC:2021
BS ISO 4754. Traditional Chinese Medicine. Fermented Cordyceps Powder
11/30/2021 - PDF - English - BSI
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BS EN ISO 80601-2-74:2021 + Redline
Tracked Changes. Medical electrical equipment Particular requirements for basic safety and essential performance of respiratory humidifying
11/30/2021 - PDF - English - BSI
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BS EN ISO 20184-3:2021 + Redline
Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes frozen tissue Isolated DNA
11/30/2021 - PDF - English - BSI
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21/30400346 DC:2021
BS ISO 19609-3. Traditional Chinese medicine. Quality and safety of raw materials finished products made with Part 3. Testing for contaminants
11/29/2021 - PDF - English - BSI
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PD CEN ISO/TS 16775:2021
Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
11/26/2021 - PDF - English - BSI
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CEN ISO/TS 16775:2021
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)
11/26/2021 - PDF - French - NBN
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CEN ISO/TS 16775:2021
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)
11/26/2021 - PDF - German - NBN
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CEN ISO/TS 16775:2021
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)
11/26/2021 - PDF - English - NBN
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NBN EN ISO 7711-1:2021
Dentistry - Diamond rotary instruments - Part 1: General requirements (ISO 7711-1:2021)
11/26/2021 - PDF - French - NBN
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NBN EN ISO 7711-1:2021
Dentistry - Diamond rotary instruments - Part 1: General requirements (ISO 7711-1:2021)
11/26/2021 - PDF - German - NBN
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NBN EN ISO 7711-1:2021
Dentistry - Diamond rotary instruments - Part 1: General requirements (ISO 7711-1:2021)
11/26/2021 - PDF - English - NBN
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€121.00
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€121.00
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BS EN ISO 14160:2021 + Redline
Tracked Changes. Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
11/25/2021 - PDF - English - BSI
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€250.00
-
BS EN IEC 80001-1:2021 + Redline
Tracked Changes. Application of risk management for IT-networks incorporating medical devices Safety, effectiveness and security in the implementation use connected or health software
11/24/2021 - PDF - English - BSI
Learn More€382.00 -
€382.00
-
UNE-EN ISO 80601-2-85:2021
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021)
11/24/2021 - PDF - Spanish - AENOR
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UNE-EN ISO 80601-2-85:2021
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021)
11/24/2021 - PDF - English - AENOR
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€57.00
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€68.40
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BS EN ISO 6717:2021 + Redline
Tracked Changes. In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
11/23/2021 - PDF - English - BSI
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21/30379304 DC:2021
BS EN ISO 10993-17. Biological evaluation of medical devices Part 17. Toxicological risk assessment device constituents
11/22/2021 - PDF - English - BSI
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BS ISO 25551:2021
Ageing societies. General requirements and guidelines for carer-inclusive organizations
11/18/2021 - PDF - English - BSI
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BS EN ISO 16256:2021 + Redline
Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
11/17/2021 - PDF - English - BSI
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BS EN ISO 10993-12:2021 + Redline
Tracked Changes. Biological evaluation of medical devices Sample preparation and reference materials
11/16/2021 - PDF - English - BSI
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BS EN ISO 13408-6:2021 + Redline
Tracked Changes. Aseptic processing of health care products Isolator systems
11/15/2021 - PDF - English - BSI
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BS ISO 25539-4:2021
Cardiovascular implants. Endovascular devices Application of ISO 17327-1 for coated endovascular
11/15/2021 - PDF - English - BSI
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NBN EN 13624:2021
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
11/12/2021 - PDF - French - NBN
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NBN EN 13624:2021
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
11/12/2021 - PDF - German - NBN
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NBN EN 13624:2021
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
11/12/2021 - PDF - English - NBN
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UNE-EN ISO 21801-1:2021
Cognitive accessibility - Part 1: General guidelines (ISO 21801-1:2020)
11/10/2021 - PDF - Spanish - AENOR
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UNE-EN ISO 21801-1:2021
Cognitive accessibility - Part 1: General guidelines (ISO 21801-1:2020)
11/10/2021 - PDF - English - AENOR
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BS EN IEC 61326-2-6:2021 + Redline
Tracked Changes. Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical
11/10/2021 - PDF - English - BSI
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BS EN ISO 11199-1:2021 + Redline
Tracked Changes. Assistive products for walking manipulated by both arms. Requirements and test methods Walking frames
11/10/2021 - PDF - English - BSI
Learn More€382.00 -
UNE-EN ISO 80601-2-67:2021
Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO 80601-2-67:2020)
11/10/2021 - PDF - Spanish - AENOR
Learn More€112.00 -
UNE-EN ISO 80601-2-67:2021
Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO 80601-2-67:2020)
11/10/2021 - PDF - English - AENOR
Learn More€134.40 -
UNE-EN ISO 80601-2-69:2021
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)
11/10/2021 - PDF - Spanish - AENOR
Learn More€124.00 -
UNE-EN ISO 80601-2-69:2021
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)
11/10/2021 - PDF - English - AENOR
Learn More€148.80 -
UNE-EN ISO 21976:2021
Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)
11/10/2021 - PDF - Spanish - AENOR
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UNE-EN ISO 21976:2021
Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)
11/10/2021 - PDF - English - AENOR
Learn More€82.80 -
IEC 62563-2:2021
IEC 62563-2:2021 Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
11/10/2021 - PDF - English, French - IEC
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€449.00
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BS EN ISO 16061:2021 + Redline
Tracked Changes. Instruments for use in association with non-active surgical implants. General requirements
11/9/2021 - PDF - English - BSI
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NBN EN ISO 4307:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
11/8/2021 - PDF - French - NBN
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NBN EN ISO 4307:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
11/8/2021 - PDF - German - NBN
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NBN EN ISO 4307:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
11/8/2021 - PDF - English - NBN
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NBN EN ISO 10535:2021
Assistive products - Hoists for the transfer of persons - Requirements and test methods (ISO 10535:2021)
11/8/2021 - PDF - French - NBN
Learn More€184.00 -
NBN EN ISO 10535:2021
Assistive products - Hoists for the transfer of persons - Requirements and test methods (ISO 10535:2021)
11/8/2021 - PDF - German - NBN
Learn More€184.00 -
NBN EN ISO 10535:2021
Assistive products - Hoists for the transfer of persons - Requirements and test methods (ISO 10535:2021, Corrected version 2023-08)
11/8/2021 - PDF - English - NBN
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BS EN IEC 61010-2-051:2021+A11:2021
Safety requirements for electrical equipment measurement, control and laboratory use Particular mixing stirring
11/4/2021 - PDF - English - BSI
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BS EN ISO 4307:2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
11/4/2021 - PDF - English - BSI
Learn More€180.00 -
BS EN 60601-1:2006+A2:2021
Medical electrical equipment General requirements for basic safety and essential performance
11/2/2021 - PDF - English - BSI
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BS EN 50527-2-3:2021
Procedure for the assessment of exposure to electromagnetic fields workers bearing active implantable medical devices Specific with neurostimulators
11/2/2021 - PDF - English - BSI
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BS EN IEC 62244:2021
Radiation protection instrumentation. Installed radiation portal monitors (RPMs) for the detection of illicit trafficking of radioactive and nuclear materials
11/2/2021 - PDF - English - BSI
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BS EN IEC 80001-1:2021
Application of risk management for IT-networks incorporating medical devices Safety, effectiveness and security in the implementation use connected or health software
11/1/2021 - PDF - English - BSI
Learn More€293.00 -
DIN EN ISO 13408-6:2021-11
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021), German version EN ISO 13408-6:2021
11/1/2021 - PDF - German - DIN
Learn More€120.84 -
DIN EN ISO 14160:2021-11
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020), German version EN ISO 14160:2021
11/1/2021 - PDF - German - DIN
Learn More€131.96 -
DIN EN ISO 21802:2021-11
Assistive products - Guidelines on cognitive accessibility - Daily time management (ISO 21802:2019), German version EN ISO 21802:2021
11/1/2021 - PDF - German - DIN
Learn More€99.35 -
DIN EN ISO 11138-8:2021-11
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021), German version EN ISO 11138-8:2021
11/1/2021 - PDF - German - DIN
Learn More€65.89 -
DIN EN ISO 17664-1:2021-11
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021), German version EN ISO 17664-1:2021
11/1/2021 - PDF - German - DIN
Learn More€104.95 -
NF EN ISO 10535, S96-305 (11/2021)
Hoists for the transfer of disabled persons - Requirements and test methods
11/1/2021 - Paper - French - AFNOR
Learn More€154.67 -
NF EN ISO 4307, S92-076 (11/2021)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
11/1/2021 - Paper - French - AFNOR
Learn More€75.67 -
DIN EN ISO 17511:2021-11
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020), German version EN ISO 17511:2021
11/1/2021 - PDF - German - DIN
Learn More€163.74 -
DIN EN ISO 15883-5:2021-11
Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021), German version EN ISO 15883-5:2021
11/1/2021 - PDF - German - DIN
Learn More€158.04 -
DIN EN ISO 20184-3:2021-11
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021), German version EN ISO 20184-3:2021
11/1/2021 - PDF - German - DIN
Learn More€85.79 -
DIN EN ISO 20166-4:2021-11
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), German version EN ISO 20166-4:2021
11/1/2021 - PDF - German - DIN
Learn More€104.95 -
DIN EN ISO 11199-2:2021-11
Assistive products for walking, manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2021), German version EN ISO 11199-2:2021
11/1/2021 - PDF - German - DIN
Learn More€110.00 -
DIN EN ISO 10651-5:2021-11
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006), German version EN ISO 10651-5:2021
11/1/2021 - PDF - German - DIN
Learn More€131.96 -
UNE-EN ISO 21563:2021
Dentistry - Hydrocolloid impression materials (ISO 21563:2021) (Endorsed by Asociación Española de Normalización in November of 2021.)
11/1/2021 - PDF - English - AENOR
Learn More€95.00 -
UNE-EN ISO 80601-2-90:2021
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO 80601-2-90:2021) (Endorsed by Asociación Española de Normalización in November of 2021.)
11/1/2021 - PDF - English - AENOR
Learn More€136.00