DIN EN 556-1 PDF Download
Standard EN EN DE
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Also Known As:
SKU152523932
Published by
Deutsches Institut für Normung
DIN
Publication Date2002-03
Pages CountPages8
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated 'STERILE'. NOTE: For the purpose of the EC Directives for medical devices (see Bibliography), designation of a medical device as 'STERILE' is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.
Details
| Descriptors | CE marking, Definitions, Ethylene oxide, Hygiene, Marking, Medical devices, Medical equipment, Medical instruments, Medical products, Medical sciences, Packages, Quality assurance, Safety, Specification (approval), Sterile, Sterile equipment, Sterility, Sterilization (hygiene), Vapours |
| ICS Codes | 11.080.01 - Sterilization and disinfection in general |
| Language(s) | English |
| File Size | 307.2 KB |
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