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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 27<\/td>\n | Contents Page <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 4 Requirements 4.1 Validation and routine control <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Table 1 \u2014 Acceptance limits and actions for occurrence of non-sterile units in process simulations in initial performance qualification <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | Table 2 \u2014 Acceptance limits and actions for occurrence of non-sterile units in process simulations in periodic requalification 4.2 Compliance 4.3 Documentation and records <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 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 \u2014 Correspondence between this European Standard and Directive 90\/385\/EEC <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC on medical devices Table ZB.1 \u2014 Correspondence between this European Standard and EU Directive 93\/42\/EEC <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98\/79\/EC on in vitro diagnostic medical devices <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Table ZC.1 \u2014 Correspondence between this European Standard and Directive 98\/79\/EC <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated ‘STERILE’ – Requirements for aseptically processed medical devices<\/b><\/p>\n |