BS EN 868-2:2017 – TC:2020 Edition
$186.33
Tracked Changes. Packaging for terminally sterilized medical devices – Sterilization wrap. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 57 |
This draft European Standard provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply. The materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 37 | 1 Scope 2 Normative references |
| 38 | 3 Terms and definitions 4 Requirements 4.1 General 4.2 Performance requirements and test methods |
| 39 | 4.2.1 General 4.2.2 Specific requirements 4.2.2.1 Wrap made of plain paper |
| 40 | 4.2.2.2 Wrap made of creped paper 4.2.2.3 Wrap made of nonwoven material |
| 41 | 4.2.2.4 Wrap made of woven textile material 4.3 Marking 4.3.1 Transport packaging |
| 42 | 4.3.2 Inner package 5 Information to be supplied by the manufacturer |
| 43 | Annex A (informative)Details of significant technical changes between this European Standard and the previous edition |
| 44 | Annex B (informative)Method for the determination of drape B.1 Apparatus B.1.1 Softness tester B.1.2 Rule B.2 Procedure B.3 Test report |
| 45 | Annex C (normative)Method for the determination of water repellency C.1 Apparatus C.2 Reagent C.3 Procedure C.4 Repeatability and reproducibility |
| 46 | C.5 Test report |
| 47 | Annex D (normative)Method for the determination of pore size D.1 Principle D.2 Test liquid D.3 Apparatus |
| 49 | D.4 Preparation of test specimens D.5 Procedure |
| 50 | D.6 Result D.6.1 Calculation and expression of results D.6.2 Derivation of formula for calculation of equivalent pore radius |
| 51 | D.7 Repeatability and reproducibility D.8 Test report |
| 52 | Annex E (informative)Repeatability and reproducibility of test methods |
