Esileht»Infoteenus

11 TERVISEHOOLDUS

Tagasi peagrupi juurde

Uued standardid


EVS-EN ISO 27020:2019
Hind 10,19 EUR
Identne ISO 27020:2019; EN ISO 27020:2019
Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2019)
This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information. This document is applicable to brackets and tubes for use in fixed orthodontic appliances. This document does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993-1 and ISO 7405.

ISO 16054:2019
Hind 33,81 EUR
Implants for surgery -- Minimum data sets for surgical implants
This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry. This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event. This document is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up. It is not the intent of this document to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.
Asendab ISO 16054:2000

IEC 80601-2-60:2019
Hind 213,54 EUR
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
IEC 80601-2-60:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE OF DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES AND DENTAL OPERATING LIGHTS, hereafter referred to as DENTAL EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. IEC 80601-2-60:2019 cancels and replaces the first edition published in 2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
Asendab IEC 80601-2-60:2012

Asendatud või tühistatud standardid


EVS-EN ISO 27020:2011
Identne ISO 27020:2010; EN ISO 27020:2010
Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2010)
This International Standard is applicable to brackets and tubes for use in fixed orthodontic appliances. This International Standard gives details of methods to compare the functional dimensions of orthodontic brackets and tubes, the test methods by which they can be determined, as well as packaging and labelling information. This International Standard does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993-1 and ISO 7405.
Keel: Inglise

ENV 737-6:2003
Identne ENV 737-6:2003
Medical gas pipeline systems - Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum
1.1 This part of this European standard specifies the dimensions and allocation of probes intended to be connected to terminal units of medical gas pipeline systems specified in EN 737-3 for use with the following medical gases: oxygen; nitrous oxide; air for breathing; carbon dioxide; oxygen/nitrous oxide mixture (50/50 % V/V ); nitric oxide/nitrogen mixture (NO 500 ul/l); air for driving surgical tools; nitrogen for driving surgical tools; vacuum.
Keel: Inglise

Kavandite arvamusküsitlus


prEN 455-1
Identne prEN 455-1
Tähtaeg 16.09.2019
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
This document specifies requirements and provides the test method for medical gloves for single use in order to determine freedom from holes.
Keel: Inglise