SFS-EN 455-4:en

Scope

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.

The standards writing body responsible for this document in Finland is General Industry Federation.

Product group(s)

11.140 Hospital equipment »

Relationships

Normative references

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)

Technical committee

CEN/TC 205 Non-active medical devices »

Directive

93/42/EEC Medical devices

http://ec.europa.eu »

Date of implementation

25.01.2010

Published

12.02.2010

Edition

1

Pages

20

Language(s)

English