Project Opening Session
NP EN ISO/IEC 17025- Requisitos gerais de competência para laboratórios de ensaio e calibraçã
IEC 60601-2-4: Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
IEC 60601-2-19: Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601-2-20: Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
IEC 60601-2-21: Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
IEC 60601-2-24: Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
IEC 60601-2-25: Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
IEC 80601-2-30: Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
IEC 80601-2-49: Medical electrical equipment — Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
WEBINAR CATIM | A CONTRIBUTION TO THE PROMOTION OF DYNAMICS OF AFFIRMATION AND VALUE CREATION IN COMPANIES
22 September 2021
ISO 1: Geometrical product specifications (GPS) — Standard reference temperature for the specification of geometrical and dimensional properties
ISO 286-1: Geometrical product specifications (GPS) — ISO code system for tolerances on linear sizes — Part 1: Basis of tolerances, deviations and fits
ISO 286-2: Geometrical product specifications (GPS) — ISO code system for tolerances on linear sizes — Part 2: Tables of standard tolerance classes and limit deviations for holes and shafts
ISO 1101: Geometrical product specifications (GPS) — Geometrical tolerancing — Tolerances of form, orientation, location and run-out
ISO 14253 - 1: Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications
ISO 14253 - 2: Geometrical Product Specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 2: Guide to the estimation of uncertainty in GPS measurement, in calibration of measuring equipment and in product verification
ISO 14253 - 3: Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 3: Guidelines for achieving agreements on measurement uncertainty statements
ISO 14253 - 4: Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 4: Background on functional limits and specification limits in decision rules
ISO 14253 - 5: Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 5: Uncertainty in verification testing of indicating measuring instruments
ISO 14253 - 6: Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 6: Generalized decision rules for the acceptance and rejection of instruments and workpieces
ISO 15530 - 1: Geometrical product specifications (GPS) — Coordinate measuring machines (CMM): Technique for determining the uncertainty of measurement — Part 1: Overview and metrological characteristics
ISO/TC 121 - Anaesthetic and respiratory equipment
ISO/TC 198 - Sterilization of health care products
ISO 80601-2-12: Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-13: Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
ISO 80601-2-56: Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ISO 80601-2-61: Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
ISO 15883-1: Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
ISO 15883-2: Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
ISO 15883-3: Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
ISO 15883-4: Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 17665-2: Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
CEN/TC 102 - Sterilizers and associated equipment for processing of medical devices
EN 285: Sterilization - Steam sterilizers - Large sterilizers
EN 13060: Small steam sterilizers
CEN/TC 204 -
Sterilization of medical devices
EN 556 - 1: Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices
EN 556 - 2: Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
IEC/TC 62 - Electrical equipment in medical practice
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories