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
Enter keywords for book title search
Search book content
Enter keywords for book content search
Filters:
FORMAT
BOOKS
All Books
PACKAGES
All Packages
EDITION
to
PUBLISHER
AABC
(1)
AAMI
(326)
ACI
(573)
AISC
(44)
ASA
(234)
ASCE
(969)
ASHRAE
(652)
ASME
(2114)
ASSE
(64)
ASTM
(92448)
AWC
(54)
AWWA
(541)
BHMA
(117)
BICSI
(33)
BIFMA
(21)
BOMA
(20)
BSI
(93277)
CHD
(3)
CRSI
(17)
IAHSS
(1)
IAPMO
(351)
ICC
(300)
IEEE
(6217)
IES
(240)
ISEA
(16)
Joint Commission
(177)
Joint Commission Int.
(1)
NETA
(5)
NFPA
(1635)
TCNA
(16)
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
(26)
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 ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
    Edition: 2013
    $538.63
    / user per year

Description of BS EN ISO 20857:2013 2013

1.1 Inclusions

1.1.1

This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.

NOTE Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that might be applicable to other health care products.

1.1.2

Although this International Standard primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

NOTE Dry heat is often used for the depyrogenation of equipment, components and health care products and its effectiveness has been demonstrated. The process parameters for sterilization and/or depyrogenation are time and temperature. Because the conditions for depyrogenation are typically more severe than those required for sterilization, a process that has been validated for product depyrogenation will result in product sterility without additional validation.

1.2 Exclusions

1.2.1

This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.

1.2.2

This International Standard does not apply to processes that use infrared or microwaves as the heating technique.

1.2.3

This International Standard does not detail a specified requirement for designating a medical device as "sterile."

NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile.” See, for example, EN 556-1 or ANSI/AAMI ST67.

1.2.4

This International Standard does not specify a quality management system for the control of all stages of production of medical devices.

NOTE It is not a requirement of this International Standard to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party.

1.2.5

This International Standard does not specify requirements for occupational safety associated with the design and operation of dry heat sterilization and/or depyrogenation facilities.

NOTE Requirements for operational safety are specified in IEC 61010-2-040. Additionally, safety regulations exist in some countries.



Standard NumberBS EN ISO 20857:2013
TitleSterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
StatusConfirmed
Publication Date2013-04-30
Identical National Standard OfISO 20857:2010, EN ISO 20857:2013
DescriptorsSterile equipment, Sterilization (hygiene), Verification, Medical equipment, Medical instruments, Process control, Sterilizers, Quality control
ICS11.080.01 Sterilization and disinfection in general
CommitteeCH/198
ISBN978 0 580 77933 6
PublisherBSI
Pages74

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