Tecnología Médica
Tecnología Médica
ISO 8536-2:2023 - Infusion equipment for medical use — Part 2: Closures for infusion bottles
02/02/2023 -
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.
The dimensional requirements...
ISO 8536-15:2022/Amd 1 - Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use — Amendment 1
02/02/2023 -
Status: Under development
ISO 8536-2 - Infusion equipment for medical use — Part 2: Closures for infusion bottles
27/01/2023 -
Status: Under development
ISO 8536-5:2004 - Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed
27/01/2023 -
This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
ISO 19979:2018 - Ophthalmic optics — Contact lenses — Hygienic management of multipatient use trial contact lenses
27/01/2023 -
ISO 19979:2018 provides guidance to manufacturers for the development of information to be provided to eye care practitioners for the hygienic management of trial hydrogel, composite and rigid...
ISO 10341:2012 - Ophthalmic instruments — Refractor heads
27/01/2023 -
This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
ISO/DIS 11040-7 - Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling
27/01/2023 -
Status: Under development
ISO/DIS 11040-4 - Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
27/01/2023 -
Status: Under development
ISO 21649:2023 - Needle-free injection systems for medical use — Requirements and test methods
27/01/2023 -
This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical...
ISO 5361:2023 - Anaesthetic and respiratory equipment — Tracheal tubes and connectors
26/01/2023 -
This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube...
ISO 10943:2023 - Ophthalmic instruments — Indirect ophthalmoscopes
26/01/2023 -
This document, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for...
ISO/DIS 80369-20 - Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods
26/01/2023 -
Status: Under development
ISO 8600-4:2023 - Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum width of insertion portion
26/01/2023 -
This document specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories.
ISO 11979-10:2018 - Ophthalmic implants — Intraocular lenses — Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
26/01/2023 -
ISO 11979-10:2018 specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power.
There...
ISO 22665:2012 - Ophthalmic optics and instruments - Instruments to measure axial distances in the eye
25/01/2023 -
ISO 22665:2012 is applicable to instruments and methods used for measuring the axial length of the human eye.
It defines minimum requirements for such instruments and systems and defines...
ISO 11990:2018 - Lasers and laser-related equipment — Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs
25/01/2023 -
This document specifies a method of testing the continuous wave (cw) laser resistance of the shaft of a tracheal tube and the cuff regions including the inflation system of tracheal tubes designed...
ISO 5832-2:2018 - Implants for surgery — Metallic materials — Part 2: Unalloyed titanium
25/01/2023 -
ISO 5832-2:2018 specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants.
Six grades of titanium based on...
ISO 19090:2018 - Tissue-engineered medical products — Bioactive ceramics — Method to measure cell migration in porous materials
25/01/2023 -
ISO 19090:2018 specifies the test method to be followed for measuring and documenting the cell migration ability of porous bioactive ceramic materials.
ISO 19090:2018 is not applicable...
ISO 10524-1:2018 - Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices
25/01/2023 -
ISO 10524-1:2018 specifies the design, construction, type testing, and marking requirements for pressure regulators (as defined in 3.18) intended for the administration of medical gases and their...
ISO 19227:2018 - Implants for surgery — Cleanliness of orthopedic implants — General requirements
24/01/2023 -
ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are...
ISO 17327-1:2018 - Non-active surgical implants — Implant coating — Part 1: General requirements
24/01/2023 -
ISO 17327-1:2018 specifies general requirements for implant coatings, comprising both surface coatings and surface modifications, applied to non-active surgical implants. This document specifies...
