Search book title
Filters:
FORMAT
BOOKS
All Books
PACKAGES
All Packages
EDITION
to
PUBLISHER
AABC
(1)
AAMI
(338)
ACI
(589)
AISC
(55)
ASA
(234)
ASCE
(996)
ASHRAE
(690)
ASME
(2161)
ASSE
(117)
ASTM
(94958)
AWC
(54)
AWWA
(575)
BHMA
(124)
BICSI
(33)
BIFMA
(21)
BOMA
(20)
BSI
(94991)
CHD
(3)
CRSI
(17)
IAHSS
(1)
IAPMO
(374)
ICC
(319)
IEEE
(6732)
IES
(241)
ISEA
(16)
Joint Commission
(184)
Joint Commission Int.
(1)
NETA
(6)
NFPA
(1667)
TCNA
(17)
TMS
(19)
USGBC
(28)
WILEY
(4)
 
AR
(6)
AZ
(7)
CA
(115)
CT
(3)
FL
(57)
ID
(5)
IL
(5)
IN
(1)
KY
(1)
LA
(2)
MI
(25)
MN
(27)
NC
(27)
NJ
(13)
NY
(61)
OH
(24)
OR
(22)
PA
(7)
RI
(8)
SC
(20)
SD
(1)
TX
(3)
VA
(50)
VT
(6)
WA
(33)
CONTENT TYPE
 Act
 Admin Code
 Announcements
 Bill
 Book
 CADD File
 CAN
 CEU
 Charter
 Checklist
 City Code
 Code
 Commentary
 Comprehensive Plan
 Conference Paper
 County Code
 Course
 DHS Documents
 Document
 Errata
 Executive Regulation
 Federal Guideline
 Firm Content
 Guideline
 Handbook
 Interpretation
 Journal
 Land Use and Development
 Law
 Legislative Rule
 Local Amendment
 Local Code
 Local Document
 Local Regulation
 Local Standards
 Manual
 Model Code
 Model Standard
 Notice
 Ordinance
 Other
 Paperback
 PASS
 Periodicals
 PIN
 Plan
 Policy
 Product
 Product - Data Sheet
 Program
 Provisions
 Requirements
 Revisions
 Rules & Regulations
 Standards
 State Amendment
 State Code
 State Manual
 State Plan
 State Standards
 Statute
 Study Guide
 Supplement
 Sustainability
 Technical Bulletin
 All
  • BSI
    BS EN 868-8:2009 Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
    Edition: 2009
    $313.97
    / user per year

Description of BS EN 868-8:2009 2009

This part of EN 868 provides 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. NOTE 1 The need for a packaging material inside the container is determined by the manufactures and users. 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 nor modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 2 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle e.g. operating temperature. NOTE 3 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.

Standard NumberBS EN 868-8:2009
TitlePackaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
StatusWithdrawn
Publication Date2009-10-31
Withdrawn Date2019-01-09
ReplacesBS EN 868-8:1999
Identical National Standard OfEN 868-8:2009
DescriptorsLids, Containers, Dimensions, Load capacity, Performance testing, Re-usable packages, Mechanical testing, Packages, Performance, Sterilization (hygiene), Design, Marking, Ageing tests, Consumer-supplier relations, Closures, Handles, Life (durability), Packaging, Medical equipment, Weight measurement, Strength of materials, Visual inspection (testing), Instructions for use, Stacking tests, Holes, Packaging materials, Sterile equipment, Steam, Medical instruments
ICS55.120 Cans. Tins. Tubes, 11.080.30 Sterilized packaging
CommitteeCH/198
ISBN978 0 580 59167 9
PublisherBSI
Pages22

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
GROUPS
X