Tecnología Médica
Tecnología Médica
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
24/11/2020 -
Abstract
This specification covers the requirements for wrought titanium-6aluminum-4vanadium alloy for use in surgical implant applications. The material shall be...
Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
24/11/2020 -
Significance and Use
5.1 Total Facet Prosthesis Components—The total facet replacement may comprise a variety of shapes and configurations. Its forms may...
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
24/11/2020 -
Significance and Use
5.1 This test procedure provides a method of evaluating the frictional torque and friction factor of hip replacement...
Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical Device
24/11/2020 -
Significance and Use
5.1 This guide describes the use of test methods in Guides F3275 and F3276 to assess the service life of a brush part intended to clean a...
ISO/FDIS 15223-1 - Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
24/11/2020 -
Status: Under development
Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
24/11/2020 -
Abstract
This test method deals with static, dynamic, and wear testing of extra-discal motion preserving implants. These implants are intended to augment spinal...
ISO/CD 23958-1 - TCM- Dermal Needle for single use — Part 1: Tapping type
24/11/2020 -
Status: Under development
ISO/CD 23958-2 - TCM- Dermal Needle for single use — Part 2: Roller Type
24/11/2020 -
Status: Under development
Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
19/11/2020 -
Significance and Use
4.1 This guide can be used to determine the fatigue and wear behavior of IVD prostheses subjected to functional and kinematic cyclic...
ISO 13175-3:2012 - Implants for surgery — Calcium phosphates — Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
19/11/2020 -
1 Scope
This part of ISO 13175 specifies requirements for monophasic hydroxyapatite bone substitutes, monophasic β-tricalcium phosphate bone substitutes and biphasic...
ISO 80601-2-70:2020 - Medical electrical equipment — Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
19/11/2020 -
This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to...
Standard Test Methods for Determining Radiopacity for Medical Use
16/11/2020 -
Significance and Use
5.1 These methods are intended to determine whether a material, product, or part of a product has the degree of radiopacity desired for its...
ISO 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
16/11/2020 -
This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or...
ISO 14534:2011 - Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements
16/11/2020 -
ISO 14534:2011 specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses.
ISO 14534:2011 does not specify...
ISO 1135-4:2015 - Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
16/11/2020 -
ISO 1135-4:2015 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with...
ISO 1135-5:2015 - Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus
16/11/2020 -
ISO 1135-5:2015 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard...
ISO 3826-3:2006 - Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features
16/11/2020 -
ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems).
The...
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
09/11/2020 -
Significance and Use
4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from...
ISO 80601-2-69:2020 - Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
09/11/2020 -
This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination...
