SFS-EN 455-4:en

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for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

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Tuoteryhmä(t)

11.140 Sairaalalaitteet ja -tarvikkeet »

Sidokset

Velvoittavat viittaukset

EN 455-1:2020 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-1:2020+A1 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-1:2020+A1:2022 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

EN 455-1:2020 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-1:2020+A1 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-1:2020+A1:2022 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties
EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 455-3:2023 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
EN ISO 11607-1:2020/A11:2022 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
EN ISO 11607-1:2020/A1:2023 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)
EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
EN ISO 11607-2:2020/A11:2022 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
EN ISO 11607-2:2020/A1:2023 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)

Tekninen komitea

CEN/TC 205 Non-active medical devices »

Direktiivi

93/42/EEC Lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

25.01.2010

Julkaisupäivä

12.02.2010

Painos

1

Sivumäärä

20

Julkaisun kieli

englanti