Verkkokauppa
SFS-EN ISO 11607-1:2020:en
Packaging for terminally sterilized medical devices. Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ISO 11607-2:2019 Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
ISO 5636-5:2013 Paper and board -- Determination of air permeance (medium range) -- Part 5: Gurley method
ISO 5636-5:2013 Paper and board -- Determination of air permeance (medium range) -- Part 5: Gurley method
Tekninen komitea
Direktiivi
90/385/EEC Aktiiviset implantoitavat lääkinnälliset laitteet
93/42/EEC Lääkinnälliset laitteet
98/79/EC In vitro diagnostiset lääkinnälliset laitteet
2017/745
2017/746
http://ec.europa.eu »
93/42/EEC Lääkinnälliset laitteet
98/79/EC In vitro diagnostiset lääkinnälliset laitteet
2017/745
2017/746
http://ec.europa.eu »
Vahvistuspäivä
24.01.2020
Julkaisupäivä
28.01.2020
Painos
4
Sivumäärä
49
Julkaisun kieli
englanti