Standard

BS EN ISO 11607-2:2020+A1:2023

Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes

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Product Details

Descriptors

Packaging processes

Sterilization (hygiene)

Quality assurance systems

Performance testing

Performance

Seals

Packaging materials

Medical equipment

Packaging

Sterile equipment

Acceptance (approval)

Quality

Packages

Sealing processes

Medical instruments

Verification

Wrapping

ICS Codes

11.080.30 Sterilized packaging

Committee

CH/198

International relationships

Identical to:

ISO 11607-2:2019/Amd 1

EN ISO 11607-2:2019/Amd 1

ISBN

978 0 539 14211 2

Publisher

BSI