Verkkokauppa
SFS-EN ISO 15883-5:2021:en
Washer-disinfectors. Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.
NOTE 1 The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2 This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.
Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.
This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.
NOTE 1 The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2 This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.
Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 15883-1 Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 15883-1 Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
Tekninen komitea
Vahvistuspäivä
27.08.2021
Julkaisupäivä
31.08.2021
Painos
1
Sivumäärä
63
Julkaisun kieli
englanti