BS EN 868-8:2018 Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods

BS EN 868-8:2018

Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods

Status : Current   Published : January 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

This document specifies test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285.

Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.




Standard NumberBS EN 868-8:2018
TitlePackaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
StatusCurrent
Publication Date09 January 2019
Normative References(Required to achieve compliance to this standard)EN 10088-1, ISO 4582, EN ISO 11607-1:2017, EN 285:2015, ISO 4017:2014, ISO 11607-1:2006/Amd 1:2014, EN ISO 4017:2014, ISO 11607-1:2006
Informative References(Provided for Information)EN 1041, ISO 11607-2, EN ISO 11607-2, EN ISO 17664:2017, ISO 17664:2017
ReplacesBS EN 868-8:2009
International RelationshipsEN 868-8:2018
Draft Superseded By17/30360915 DC
DescriptorsSterile equipment, Holes, Consumer-supplier relations, Re-usable packages, Mechanical testing, Closures, Visual inspection (testing), Medical instruments, Packaging materials, Packages, Ageing tests, Medical equipment, Handles, Instructions for use, Performance, Packaging, Marking, Design, Stacking tests, Dimensions, Sterilization (hygiene), Performance testing, Steam, Strength of materials, Weight measurement, Containers, Life (durability), Load capacity, Lids
ICS11.080.30
55.120
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal Conteneurs réutilisables de stérilisation pour stérilisateurs à la vapeur d'eau conformes à l'EN 285. Exigences et méthodes d'essai
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte Wiederverwendbare Sterilisierbehälter für Dampf- Sterilisatoren nach EN 285. Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 98600 0
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size646 KB
Price£182.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Worldwide Standards
We can source any standard from anywhere in the world


BSOL

The faster, easier way to work with standards


Customers who bought this product also bought

  • BS EN 868-5:2018
    Packaging for terminally sterilized medical devices Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods
  • BS EN 868-9:2018
    Packaging for terminally sterilized medical devices Uncoated nonwoven materials of polyolefines. Requirements and test methods
  • BS EN 868-10:2018
    Packaging for terminally sterilized medical devices Adhesive coated nonwoven materials of polyolefines. Requirements and test methods
  • BS EN ISO 15883-4:2018
    Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes