Tecnología Médica
Tecnología Médica
ISO 15223-1 - Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
13/05/2021 -
Status: Under development
ISO/AWI 5910 - Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
11/05/2021 -
Status: Under development
ISO 5910:2018 - Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
11/05/2021 -
1.1 This document applies to all heart valve repair systems that have an intended use to repair and/or improve the function of native human heart valves by acting either on the valve apparatus or...
ISO 19980 - Ophthalmic instruments — Corneal topographers
11/05/2021 -
Status: Under development
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
06/05/2021 -
Abstract This specification covers ultra-high-molecular-weight polyethylene (UHMWPE) powder and fabricated forms for use in surgical implants. UHMWPE powder shall be of...
ISO/PRF 21917 - Anaesthetic and respiratory equipment — Voice prostheses
03/05/2021 -
Status: Under development
ISO/CD 8536-2 - Infusion equipment for medical use — Part 2: Closures for infusion bottles
03/05/2021 -
Status: Under development
ISO/PRF TS 17137 - Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
03/05/2021 -
Status: Under development
Standard Practice for Care and Handling of Orthopedic Implants and Instruments
26/04/2021 -
Abstract
This practice covers recommended procedures for the handling of orthopedic implants and instruments. Hospital receiving personnel, central supply personnel,...
ISO/DIS 10651-4 - Lung ventilators — Part 4: Particular requirements for user-powered resuscitators
26/04/2021 -
Status: Under development
ISO/CD 18562-4 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
26/04/2021 -
Status: Under development
ISO 29783-3:2016 - Prosthetics and orthotics — Vocabulary — Part 3: Pathological gait (excluding prosthetic gait)
19/04/2021 -
ISO 29783-3:2016 specifies a method of describing abnormal gait patterns resulting from pathology (excluding prosthetic gait) by identifying the deviations from the normal pattern of gait during...
ISO 7740:1985 - Instruments for surgery — Scalpels with detachable blades — Fitting dimensions
19/04/2021 -
Lays down the dimensions of two sizes of fitting features for detacheable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable...
ISO 7197:2006 - Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components
19/04/2021 -
ISO 7197:2006 specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes...
ISO 5832-1:2016 - Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
19/04/2021 -
ISO 5832-1:2016 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.
NOTE 1 The mechanical...
ISO 7206-13:2016 - Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
19/04/2021 -
ISO 7206-13:2016 describes a method of determining the torque required, under specified laboratory conditions, to loosen the fixation of the head of hip joint prostheses in which the head is not...
ISO 21534:2007 - Non-active surgical implants — Joint replacement implants — Particular requirements
19/04/2021 -
ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the...
ISO 5837-1:1985 - Implants for surgery — Intramedullary nailing systems — Part 1: Intramedullary nails with cloverleaf or V-shaped cross-section
19/04/2021 -
Specifies the main and fitting dimensions for intramedullary nails of the cross-section mentioned. It also specifies extracting hooks and recommends the diameters of the guide wires to be used...
