Verkkokauppa
SFS-EN ISO 17664-2:2024:en
Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Part 2: Non-critical medical devices (ISO 17664-2:2021)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact).
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:
a) preparation before processing;
b) cleaning;
c) disinfection;
d) drying;
e) inspection and maintenance;
f) packaging;
g) storage;
h) transportation.
This document excludes processing of:
1) critical and semi-critical medical devices;
2) medical devices intended to be sterilized;
3) textile medical devices used in patient draping systems or surgical clothing;
4) medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact).
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:
a) preparation before processing;
b) cleaning;
c) disinfection;
d) drying;
e) inspection and maintenance;
f) packaging;
g) storage;
h) transportation.
This document excludes processing of:
1) critical and semi-critical medical devices;
2) medical devices intended to be sterilized;
3) textile medical devices used in patient draping systems or surgical clothing;
4) medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
Tässä julkaisussa ei ole velvoittavia viittauksia
Tekninen komitea
Direktiivi
Vahvistuspäivä
05.01.2024
Julkaisupäivä
09.01.2024
Painos
1
Sivumäärä
33
Julkaisun kieli
englanti