Cart (0)
  • No items in cart.
Total
$0
There is a technical issue about last added item. You can click "Report to us" button to let us know and we resolve the issue and return back to you or you can continue without last item via click to continue button.
Home
Content
Tour
eLibrary
Store
Search book title
Filters:
FORMAT
BOOKS
All Books
PACKAGES
All Packages
EDITION
to
PUBLISHER
AABC
(1)
AAMI
(337)
ACI
(585)
AISC
(54)
ASA
(234)
ASCE
(996)
ASHRAE
(657)
ASME
(2154)
ASSE
(117)
ASTM
(94142)
AWC
(54)
AWWA
(560)
BHMA
(124)
BICSI
(33)
BIFMA
(21)
BOMA
(20)
BSI
(94146)
CHD
(3)
CRSI
(17)
IAHSS
(1)
IAPMO
(374)
ICC
(309)
IEEE
(6631)
IES
(241)
ISEA
(16)
Joint Commission
(177)
Joint Commission Int.
(1)
NETA
(6)
NFPA
(1646)
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
(31)
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 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated \"STERILE\" - Requirements for aseptically processed medical devices
    Edition: 2015
    $313.97
    / user per year

Description of BS EN 556-2:2015 2015

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.

Standard NumberBS EN 556-2:2015
TitleSterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices
StatusUnder Review
Publication Date2015-09-30
ReplacesBS EN 556-2:2003
Identical National Standard OfEN 556-2:2015
DescriptorsParticulate materials, Contaminants, Quality control, Microorganisms, Medical instruments, Sterilization (hygiene), Medical equipment, Contamination, Controlled-atmosphere rooms, Sterile equipment, Environment (working)
ICS11.080.01 Sterilization and disinfection in general
CommitteeCH/198
ISBN978 0 580 80961 3
PublisherBSI
Pages20

The following editions for this book are also available...

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