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BS EN 556-2:2015 – TC:2020 Edition

BS EN 556-2:2015 – TC:2020 Edition

$134.27

Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated ‘STERILE’ – Requirements for aseptically processed medical devices

Published By Publication Date Number of Pages
BSI 2020 43
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This European Standard specifies the requirements for an aseptically processed medical device to be designated ‘STERILE’. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is ‘STERILE’ is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.

PDF Catalog

PDF Pages PDF Title
27 Contents Page
28 European foreword
29 Introduction
30 1 Scope
2 Normative references
31 3 Terms and definitions
33 4 Requirements
4.1 Validation and routine control
34 Table 1 — Acceptance limits and actions for occurrence of non-sterile units in process simulations in initial performance qualification
35 Table 2 — Acceptance limits and actions for occurrence of non-sterile units in process simulations in periodic requalification
4.2 Compliance
4.3 Documentation and records
36 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices
Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC
37 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices
Table ZB.1 — Correspondence between this European Standard and EU Directive 93/42/EEC
38 Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices
39 Table ZC.1 — Correspondence between this European Standard and Directive 98/79/EC
40 Bibliography

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BS EN 556-2:2015 - TC
$134.27