Tecnología Médica
Tecnología Médica
ISO/DIS 22926 - Implants for surgery — Specification and verification of synthetic anatomical bone models for testing
22/08/2022 -
Status: Under development
ISO/FDIS 21536 - Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
08/08/2022 -
Status: Under development
ISO/CD 7197 - Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components
08/08/2022 -
Status: Under development
ISO/FDIS 21535 - Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
04/08/2022 -
Status: Under development
ISO/TS 24560-1:2022 - Tissue-engineered medical products — MRI evaluation of cartilage — Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolimium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping
02/08/2022 -
This document provides a principle to determine the parameter settings and operating methods for the evaluation of the composition and structure of articular cartilage by dGEMRIC and T2-mapping...
ISO/CD 5910 - Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
02/08/2022 -
Status: Under development
ISO 18369-3:2017 - Ophthalmic optics — Contact lenses — Part 3: Measurement methods
28/07/2022 -
ISO 18369-3:2017 specifies the methods for measuring the physical and optical properties of contact lenses specified in ISO 18369?2, i.e. radius of curvature, label back vertex power, diameter,...
ISO 18369-1:2017 - Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
28/07/2022 -
ISO 18369-1:2017 identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and,...
ISO 18369-2:2017 - Ophthalmic optics — Contact lenses — Part 2: Tolerances
28/07/2022 -
ISO 18369-2:2017 specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses at the time of manufacture.
These...
ISO 18369-4:2017 - Ophthalmic optics — Contact lenses — Part 4: Physicochemical properties of contact lens materials
28/07/2022 -
ISO 18369-4:2017 specifies the methods of testing the physicochemical properties of contact lens materials. These are extraction, rigid lens flexure and breakage, oxygen permeability, refractive...
ISO 19213:2017 - Implants for surgery — Test methods of material for use as a cortical bone model
27/07/2022 -
ISO 19213:2017 specifies mechanical test methods for characterizing cortical bone model materials for use as a standard model for performing mechanical tests for devices or instruments used in...
ISO/DIS 14630 - Non-active surgical implants — General requirements
25/07/2022 -
Status: Under development
ISO 13781:2017 - Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
25/07/2022 -
ISO 13781:2017 describes methods for the determination of chemical and mechanical changes in poly(lactide)-based homopolymers, copolymers and/or blends induced under in vitro degradation...
ISO 11658:2012 - Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
25/07/2022 -
This standard was last reviewed and confirmed in 2017. Therefore this version remains current.
ISO/CD 5832-7 - Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
28/06/2022 -
Status: Under development
ISO/CD 5832-11 - Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy
28/06/2022 -
Status: Under development
ISO/CD 5832-1 - Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
28/06/2022 -
Status: Under development
ISO/CD 5832-4 - Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy
28/06/2022 -
Status: Under development
ISO/CD 14607 - Non-active surgical implants — Mammary implants — Particular requirements
23/05/2022 -
Status: Under development
